A Phase III Study of Cabazitaxel With or Without Carboplatin in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC), Stratified by Aggressive Variant Signature

This phase III trial compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Prednisone is often given together with chemotherapy drugs. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs and to help the chemotherapy work. Giving carboplatin with the standard of care chemotherapy drug cabazitaxel may be better at treating metastatic castrate-resistant prostate cancer.

Start Date12 Dec 2024

Sponsor / Collaborator

National Cancer Institute

NCT06353386 / RecruitingPhase 1/2

MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01).
The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.

Start Date20 May 2024

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

CTRI/2024/04/066247 / Not yet recruitingPhase 2

A Phase-2, Open-label, Randomized, Parallel-group, Three- arm, Study to Assess Efficacy and Safety of Cabazitaxel Lipid Tablet in Combination with Prednisone for the Treatment of Adult Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with a Docetaxel- containing Treatment Regimen - NIL

Start Date04 May 2024

Sponsor / Collaborator

Intas Pharmaceuticals Ltd.

100 Clinical Results associated with Cabazitaxel Acetone

100 Translational Medicine associated with Cabazitaxel Acetone

100 Patents (Medical) associated with Cabazitaxel Acetone

1,140

Literatures (Medical) associated with Cabazitaxel Acetone

01 Feb 2024·Colloids and surfaces. B, Biointerfaces

Quality by design fostered fabrication of cabazitaxel loaded pH-responsive Improved nanotherapeutics against prostate cancer

Article

Author: Srinivasarao, Dadi A ; Shah, Saurabh ; Sharma, Anamika ; Kumar, Prakash ; Singh, Gurpreet ; Srivastava, Saurabh ; Shinde, Akshay ; Vambhurkar, Ganesh ; Famta, Paras ; Mehra, Ankit ; Pandey, Giriraj ; Mourya, Atul ; Prasad, Sajja Bhanu ; Kumar, Rahul ; Khatri, Dharmendra Kumar ; Madan, Jitender

Cabazitaxel has been approved for the treatment of prostate cancer since 2010. However, its poor solubility and permeability pitfalls prevent its accumulation at the target site and promote severe adverse effects. About 90% of prostate cancer (PCa) patients suffer from bone metastasis. This advent reports the development of CBZ-loaded pH-responsive polydopamine nanoparticles (CBZ NP) against metastatic PCa cells. Quality by design (QbD) and multivariate analysis tools were employed for the optimization of CBZ NP. Amorphisation of CBZ along with metastatic microenvironment responsive release was observed thereby imparting spatial release and circumventing solubility pitfalls. CBZ NP retained its cytotoxic potential, with a significant increase in quantitative cellular uptake. Apoptotic markers observed from nuclear staining with elevated reactive oxygen species (ROS) and mitochondrial damage revealed by JC-1 staining demonstrated the efficacy of CBZ NP against PC-3 cells with good serum stability and diminished hemolysis. Cell cycle analysis revealed substantial S and G2/M phase arrest with enhancement in apoptosis was observed. Western blot studies revealed an elevation in caspase-1 and suppression in Bcl-2 indicating enhanced apoptosis compared to the control group. Substantial reduction in the diameter of 3D-Tumoroid and enhanced cell proliferation inhibition indicated the efficacy of CBZ NP in PCa. Thus, we conclude that CBZ NP could be a promising Nanotherapeutic approach for PCa.

01 Feb 2024·The Lancet. Oncology

Actinium-225-PSMA radioligand therapy of metastatic castration-resistant prostate cancer (WARMTH Act): a multicentre, retrospective study

Article

Author: Sathekge, Mike M ; Davis, Cindy ; Thakral, Parul ; Kratochwil, Clemens ; Hekimsoy, Türkay ; Tauber, Robert ; Reed, Janet ; Yadav, Madhav Prasad ; Knoesen, Otto ; Ndlovu, Honest ; Lenzo, Nat P ; Bruchertseifer, Frank ; Ballal, Sajana ; Singh, Aviral ; Lawal, Ismaheel O ; Eiber, Mathias ; Sood, Ashwani ; Mdlophane, Amanda H ; Cardaci, Giuseppe ; Mahapane, Johncy ; Maserumule, Letjie C ; Rathke, Hendrik ; Pant, Vineet ; Mokoala, Kgomotso M G ; Sen, Ishita B ; Morgenstern, Alfred ; Bal, Chandrasekhar

BACKGROUND:

Actinium-225 (²²⁵Ac) prostate-specific membrane antigen (PSMA) radioligand therapy (RLT) is a novel therapy for metastatic castration-resistant prostate cancer (mCRPC). We aimed to report the safety and antitumour activity of ²²⁵Ac-PSMA RLT of mCRPC in a large cohort of patients treated at multiple centres across the world.

METHODS:

This retrospective study included patients treated at seven centres in Australia, India, Germany, and South Africa. We pooled data of consecutive patients of any age and Eastern Cooperative Oncology Group performance status with histopathologically confirmed adenocarcinoma of the prostate who were treated with one or more cycles of 8 MBq ²²⁵Ac-PSMA RLT administered intravenously for mCRPC. Previous lines of mCRPC treatment included taxane-based chemotherapy, androgen-receptor-axis inhibitors, lutetium-177 (¹⁷⁷Lu) PSMA RLT, and radium-223 dichloride. The primary outcomes were overall survival and progression-free survival.

FINDINGS:

Between Jan 1, 2016, and May 31, 2023, 488 men with mCRPC received 1174 cycles of ²²⁵Ac-PSMA RLT (median two cycles, IQR 2-4). The mean age of the patients was 68·1 years (SD 8·8), and the median baseline prostate-specific antigen was 169·5 ng/mL (IQR 34·6-519·8). Previous lines of treatment were docetaxel in 324 (66%) patients, cabazitaxel in 103 (21%) patients, abiraterone in 191 (39%) patients, enzalutamide in 188 (39%) patients, ¹⁷⁷Lu-PSMA RLT in 154 (32%) patients, and radium-223 dichloride in 18 (4%) patients. The median follow-up duration was 9·0 months (IQR 5·0-17·5). The median overall survival was 15·5 months (95% CI 13·4-18·3) and median progression-free survival was 7·9 months (6·8-8·9). In 347 (71%) of 488 patients, information regarding treatment-induced xerostomia was available, and 236 (68%) of the 347 patients reported xerostomia after the first cycle of ²²⁵Ac-PSMA RLT. All patients who received more than seven cycles of ²²⁵Ac-PSMA RLT reported xerostomia. Grade 3 or higher anaemia occurred in 64 (13%) of 488 patients, leukopenia in 19 (4%), thrombocytopenia in 32 (7%), and renal toxicity in 22 (5%). No serious adverse events or treatment-related deaths were recorded.

INTERPRETATION:

²²⁵Ac-PSMA RLT shows a substantial antitumour effect in mCRPC and represents a viable therapy option in patients treated with previous lines of approved agents. Xerostomia is a common side-effect. Severe bone marrow and renal toxicity are less common adverse events.

FUNDING:

None.

01 Feb 2024·The Prostate

Berbamine targets cancer stem cells and reverses cabazitaxel resistance via inhibiting IGF2BP1 and p‐STAT3 in prostate cancer

Article

Author: Pohla, Heike ; Buchner, Alexander ; Lyu, Chen ; Stadlbauer, Birgit ; Wang, Lili ; Nößner, Elfriede

Abstract:

Background:

Cancer stem cells (CSCs) are a small subpopulation of tumor cells with the capability of self‐renewal and drug resistance, leading to tumor progression and disease relapse. Our study aimed to investigate the antitumor effect of berbamine, extracted from berberis amurensis, on prostate CSCs.

Methods:

Sphere formation was used to collect prostate CSCs. The viability, proliferation, invasion, migration, and apoptosis assays were used to evaluate the antitumor effect of berbamine on prostate CSCs. Prostate CSC markers were analyzed by flow cytometry and qRT‐PCR. Small RNA sequencing analysis was conducted to analyse miRNAs. Exosomes were extracted using the ExoQuick‐TC kit and verified by testing exosomal markers using western blot.

Results:

Berbamine targets prostate CSCs. Additionally, berbamine enhanced the antitumor effect of cabazitaxel, a second‐line chemotherapeutic drug for advanced prostate cancer, and re‐sensitized Cabazitaxel‐resistant PCa cells (CabaR‐DU145) to cabazitaxel by inhibiting ABCG2, CXCR4, IGF2BP1, and p‐STAT3. Berbamine enhanced the expression of let‐7 miRNA family and miR‐26b and influenced the downstream targets IGF2BP1 and p‐STAT3, respectively. Silencing CXCR4 and ABCG2 downregulated the expression of IGF2BP1 and p‐STAT3, respectively. Importantly, berbamine enhanced also levels of exosomal let‐7 family and miR‐26b, suggesting that berbamine possibly influences the expression of let‐7 family and miR‐26b through exosome delivery. Exosomes derived from berbamine‐treated CabaR‐DU145 cells re‐sensitized the cells to cabazitaxel.

Conclusion:

Berbamine enhanced the toxic activity of cabazitaxel and reversed cabazitaxel resistance potentially through CXCR4/exosomal let‐7/IGF2BP1 and ABCG2/exosomal miR‐26b/p‐STAT3 axes.

News (Medical) associated with Cabazitaxel Acetone

25 Jan 2024

·www.globenewswire.com

Bionano Announces Publication of a Study that Applied OGM to Discovery of Structural Variants Driving Drug Resistance and Sensitivity in Cancer

SAN DIEGO, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced a peer-reviewed publication in Cancers from a team of cancer researchers primarily at the NCI-Designated Cancer Center, Sanford Burnham Prebys Medical Discovery Institute and Scripps MD Anderson in La Jolla, California. The publication describes what could be the first study to use optical genome mapping (OGM) for the discovery of structural variants (SVs) that drive drug resistance and sensitivity in cancer. Study Design Patient Samples. The study analyzed 26 leukemia samples from 23 subjects, including 3 samples from subjects after relapse. Genome Variation Signatures. The study compared genome variation signatures obtained from the leukemia samples by OGM and by classical cytogenetic methods including karyotyping (KT) and fluorescence in situ hybridization (FISH). Drug Library. The study used a broad collection of 120 cancer drugs based on the Oncology Drug Library (ODL, ODL2 and ODL3) and the FDA-approved oncology collection drugs from the NCI’s Developmental Therapeutics Program, including some experimental agents and those in phase II/III trials. Drug Resistance & Sensitivity Assay. The study used a cell viability and drug screening assay based on growing leukemia-enriched cell collections in the presence of different concentrations of drug agents to measure cell viability. Cells that grew well in the presence of drugs were determined to be resistant and those that didn’t were determined to be sensitive. Key Findings Overall, the study shows that OGM for SV detection combined with drug sensitivity data for the same samples is a useful approach to identifying potentially pathogenic SVs that may be drivers of drug sensitivity or resistance. Key findings are as follows: OGM detected all SVs that had been observed using classical cytogenetic methods as well as multiple additional variants that were not previously reportedBCR-ABL1 translocated leukemia samples are sensitive to the tyrosine kinase inhibitor Nilotinib, as expected, but exhibit resistance to proteasome inhibitorsDrug sensitivities associated with previously unreported genomic rearrangements were revealed Leukemia samples with KMT2A translocations are associated with drug sensitivities to the microtubule disruptors Paclitaxel and Cabazitaxel and resistance to Bcl-2 family inhibitorsChemosensitivity associations with SVs detected by OGM are able to reveal several potential new treatment strategies for leukemia “This paper represents incredibly well-done research that demonstrates the potential biological and clinical significance of structural variants and the ability of OGM to detect SVs in a reliable and efficient sample to answer workflow. SVs are historically underrepresented in genomics studies due to limitations associated with classical cytogenetic methods and sequencing. We are pleased to see this type of biomarker discovery research and hope it will lead others to conduct more studies, which we believe will help pharmaceutical companies develop better drugs and clinicians provide the right drugs to the right patients,” commented Erik Holmlin, PhD, president and chief executive officer of Bionano. The paper is available at: https://www.mdpi.com/2072-6694/16/2/418. About Bionano Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. The Company also offers an industry-leading, platform-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. The Company additionally offers nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. For more information, visit www.bionano.com, www.bionanolaboratories.com or www.purigenbio.com. Bionano’s OGM products are for research use only and not for use in diagnostic procedures. Forward-Looking Statements of Bionano This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “could,” “potential,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and utility of OGM to detect SVs in leukemia samples; the ability and utility of OGM to detect SVs that drive drug resistance and sensitivity in cancer; the ability and utility of OGM to detect SVs compared to classical cytogenetic methods, including FISH and KT; the ability and utility of OGM to detect SVs in a reliable and efficient sample to answer workflow; the ability and utility of OGM to detect novel causative or pathogenic SVs associated with drug efficacy and resistance; and execution of our stated strategies and plans. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of geopolitical and macroeconomic developments, such as recent and potential future bank failures, supply chain disruptions, global pandemics, inflation and the ongoing conflicts between Ukraine and Russian and Israel and Hamas, on our business and the global economy; general market conditions; the failure of OGM to detect SVs in leukemia samples; the failure of OGM to detect SVs that drive drug resistance and sensitivity in cancer; the failure of OGM to detect SVs compared to classical cytogenetic methods, including FISH and KT; the failure of OGM to detect SVs in a reliable and efficient sample to answer workflow; the failure of OGM to detect novel causative or pathogenic SVs associated with drug efficacy and resistance; study results that differ or contradict the results reported in the study referenced in this press release; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; our need and ability to obtain sufficient financing to fund our strategic plans and commercialization efforts, our ability to effectively manage our uses of cash, and our ability to continue as a “going concern”; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2022 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. CONTACTSCompany Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionano.com Investor Relations:David HolmesGilmartin Group+1 (858) 888-7625IR@bionano.com

Clinical Study

09 Jan 2024

·www.prnewswire.com

Castration-Resistant Prostate Cancer (CRPC) Treatment Market size to grow by USD 5.98 billion from 2023 to 2028, North America to account for 47% of market growth- Technavio

NEW YORK, Jan. 8, 2024 /PRNewswire/ -- The castration-resistant prostate cancer (CRPC) treatment market is expected to grow by USD 5.98 billion from 2023 to 2028. In addition, the momentum of the market will progress at a CAGR of 8.83% during the forecast period, according to Technavio Research. The market has been segmented by distribution channels (hospital pharmacies, retail pharmacies, and online pharmacies), therapy (hormonal therapy, chemotherapy, and others), and geography (North America, Europe, Asia, and the Rest of the World (ROW)). North America is estimated to contribute 47% to the growth of the global market during the forecast period. Moreover, this region's market growth is driven by high-quality healthcare infrastructure. Continue Reading Technavio has announced its latest market research report titled Global Castration-Resistant Prostate Cancer (CRPC) Treatment Market 2024-2028 This report offers an up-to-date analysis of the current market scenario, the latest trends and drivers, and the overall market environment. Read a Free PDF Sample Report Company Profile: Active Biotech AB, Allarity Therapeutics Inc., Amgen Inc., Amneal Pharmaceuticals Inc., Astellas Pharma Inc., Bayer AG, BeiGene Ltd., Daiichi Sankyo Co. Ltd., Dr Reddys Laboratories Ltd., Everest Pharmaceuticals Ltd., F. Hoffmann La Roche Ltd., Johnson and Johnson, Medias Klinikum GmbH and Co. KG, Merck KGaA, Novartis AG, Pfizer Inc., Robotic Prostate Centre Cambridge, Sanofi SA, The Focal Therapy Clinic, and Ono Pharmaceutical Co. Ltd. Allarity Therapeutics Inc. - The company offers Castration-Resistant Prostate Cancer CRPC treatments such as LiPlaCis and Irofulven, in Phase II trials. To gain access to more company profiles available with Technavio, buy the report! Castration-Resistant Prostate Cancer (CRPC) Treatment Market: Segmentation Analysis The hospital pharmacies segment is estimated to witness significant growth during the forecast period. A specific category of pharmacies operating within the premises of a healthcare facility is included in this hospital pharmacy segment. Learn about the contribution of each segment summarized in concise infographics and thorough descriptions. View a Free PDF Sample Report Castration-Resistant Prostate Cancer (CRPC) Treatment Market: Market Dynamics Key Driver The increasing Early detection of prostate cancer is a key factor driving market growth. This growth has intensified the use of Androgen Deprivation Therapy (ADT), Chemotherapy (including Docetaxel and cabazitaxel), and novel medications like Abiraterone Acetate, Enzalutamide, Radium-223 Dichloride. Additionally, the emergence of immunotherapy, PARP Inhibitors such as Olaparib, and advancements in targeted therapies focusing on Prostate-Specific Membrane Antigen (PSMA) are further catalyzing innovative treatment approaches for CRPC. Leading Trend The evolution of CRPC treatment options stands as a significant trend driving the growth of the Castration-Resistant Prostate Cancer (CRPC) Treatment Market. This evolution includes Clinical Trials, addressing Hormone Refractory Prostate Cancer and Metastatic CRPC (mCRPC), with a focus on Novel Therapeutics developed by Biopharmaceutical Companies. FDA Approvals of these treatments, alongside an emphasis on Personalized Medicine to combat Treatment Resistance Mechanisms, are shaping the landscape. Additionally, attention to Health Economics and Reimbursement aligns with improving Patient's Quality of Life. Significant Challenge The prevalence of health complications linked to CRPC drugs emerges as a significant challenge impeding the Castration-Resistant Prostate Cancer (CRPC) Treatment Market growth. Challenges persist regarding Biomarkers in CRPC and Genetic Testing, impacting the efficacy of treatments like Radiopharmaceuticals and Bone-targeted Therapy. Market Trends and Forecasts, influenced by Healthcare Policies and Regulations, affect the Drug Development Pipeline and Oncology Research and Development, complicating Global Market Analysis within the CRPC treatment landscape. Identify key trends, drivers, and challenges in the market. Download a sample to gain access to this information. Related Reports The fallopian tube cancer treatment market is estimated to generate a value of USD 998.75 million in 2018, anticipated to reach USD 2.14 billion by 2028. The head and neck cancer treatment market size is estimated to grow by USD 5,077.38 million at a CAGR of 11.27% between 2022 and 2027. What are the key data covered in this castration-resistant prostate cancer (CRPC) treatment market report? CAGR of the market during the forecast period Detailed information on factors that will drive the growth of the castration-resistant prostate cancer (CRPC) treatment market between 2023 and 2028. Precise estimation of the castration-resistant prostate cancer (CRPC) treatment market size and its contribution to the market in focus on the parent market Accurate predictions about upcoming trends and changes in consumer behavior Growth of the castration-resistant prostate cancer (CRPC) treatment market across North America, Europe, Asia, and ROW A thorough analysis of the market's competitive landscape and detailed information about companies Comprehensive analysis of factors that will challenge the growth of castration-resistant prostate cancer (CRPC) treatment market companies. ToC: Executive Summary Market Landscape Market Sizing Historic Market Sizes Five Forces Analysis Market Segmentation by Distribution Channel Market Segmentation by Therapy Market Segmentation by Geography Customer Landscape Geographic Landscape Drivers, Challenges, & Trends Company Landscape Company Analysis Appendix About Technavio Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provide actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contacts Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

Phase 2Immunotherapy

13 Dec 2023

·www.prnewswire.com

Metastatic Prostate Cancer Market to Exhibit Positive Growth at a CAGR of 22% and 7.5% for mHSPC and mCRPC, respectively During the Study Period (2019-2032), Assesses DelveInsight

The dynamics of the metastatic prostate cancer market are anticipated to change in the coming years owing to the rise in the number of companies taking interest in the development of specific drugs for mCRPC and nmCRPC along with increasing awareness and penetration of already approved prostate cancer drugs. LAS VEGAS, Dec. 13, 2023 /PRNewswire/ -- DelveInsight's Metastatic Prostate Cancer Market Insights report includes a comprehensive understanding of current treatment practices, metastatic prostate cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Metastatic Prostate Cancer Market Report As per DelveInsight analysis, the total market size in the 7MM for metastatic castration-resistant prostate cancer (mCRPC) was estimated to be nearly USD 6.4 billion in 2022, which is expected to show positive growth by 2032. In 2022, the United States held the highest market share for mCRPC and mCSPC in the 7MM, at 63% and 61%, respectively, followed by the EU4 countries and the UK. As per DelveInsight estimates, the total prevalent population of prostate cancer in the 7MM was nearly 8 million cases in 2022. These cases will increase during the study period, i.e., 2019–2032. Leading metastatic prostate cancer companies such as AstraZeneca, Merck Sharp & Dohme, Hinova Pharmaceuticals, Pfizer, Astellas Pharma, Modra Pharmaceuticals, AB Science, Eli Lilly and Company, Zr Pharma & GmbH, Bristol-Myers Squibb, Ipsen, Exelixis, Takeda, Janssen Research & Development, Tesaro, Lantheus Holdings, Kintor Pharmaceutical, MacroGenics, Daiichi Sankyo, Madison Vaccines, Novartis, Point Biopharma, Xencor, Essa Pharma , Telix International, Bayer, Arvinas, and others are developing novel metastatic prostate cancer drugs that can be available in the metastatic prostate cancer market in the coming years. The promising metastatic prostate cancer therapies in the pipeline include HC-1119, Talazoparib, Enzalutamide, Niraparib, Boosted Oral Docetaxel, Masitinib, EPI-7386, Verzenio, 177Lu-PSMA-617, Capivasertib, I-131-1095, Proxalutamide (GT0918), MGC018, DS-7300, MVI-816, ARV-110, 177Lu-PNT2002 (PNT2002), Vudalimab (XmAb20717), 177Lu-DOTA-rosopatamab (TLX591), and others. Established therapies in the metastatic prostate cancer market include Astella/Pfizer's and Jansenn's blockbuster products XTANDI and ZYTIGA, respectively, approved for metastatic patients for over a decade now. Even though ZYTIGA's generics have entered the US market since 2019, and the EU since late 2022, leading to a drastic decline in the revenue mainly in the US, the product is extensively being evaluated in combination with novel emerging therapies, leading to an increase in patient share on the compound abiraterone acetate. Whereas, Jansenn's XTANDI, the biggest revenue generator in the prostate cancer market, has witnessed stable growth since 2021 owing to increased competition. Quantitatively mCRPC pipeline seems to be quite strong, however with recent failures/terminations of several trials of certain therapies in the past year, we have mentioned the most promising ones, which include ESSA Pharma's EPI-7386, Macrogenics, and Daiichi's anti-B7-H3 Antibody Drug Conjugates, MGC-018 and DS-7300 respectively, Arvinas, AR-targeted PROTAC protein degrader, and Point Biopharma's Radioligand therapy. Except for Point Biopharma's therapy, none of these potential players have initiated a Phase III trial, even though Arvinas is planning to opt for an accelerated approval based on its Phase II data readout. The landscape of mHSPC has evolved tremendously in the past decades. The treatment paradigm has shifted from androgen deprivation therapy (ADT) alone to doublet combinations comprising ADT with docetaxel or an androgen receptor inhibitor, and now triplet therapy involving all three classes of agents. Apart from XTANDI, ZYTIGA, and ERLEADA in the mCSPC market, Bayer's NUBEQA is another rising contender with a strong uptake in a short period. Bayer is further strategizing to increase the prescription by volume for NUBEQA by label expansion in patients who are not eligible for chemotherapy in the ARANOTE Phase III trial. PARP inhibitors such as AKEEGA and TALZENNA are also currently being evaluated in the mHSPC space alone and with ARIs. Novartis' radioligand therapy, PLUVICTO approved in 2022, has generated an unexpected revenue from the third-line mCRPC setting, further plans to expand in an earlier line in mCRPC by 2024 in the United States. The approval of PLUVICTO has also marked a crucial advancement in treating progressive mCRPC, offering improved survival rates for those with limited treatment options. The drug had an exceptionally robust initial market performance, garnering a stronger-than-expected uptake in the US. The drug is currently being studied in the Phase III PSMAddition study to see if that triplet combination is better than ADT and an androgen receptor signaling inhibitor alone in patients with mHSPC. Discover which therapies are expected to grab the major metastatic prostate cancer market share @ Metastatic Prostate Cancer Market Report Metastatic Prostate Cancer Overview Prostate cancer, a form of malignancy specific to the prostate gland within the male reproductive system, can advance to a metastatic stage, spreading from the prostate to other areas of the body. This advanced stage is often referred to as metastatic or advanced prostate cancer, commonly extending to lymph nodes or bones. Prostate cancer symptoms can differ widely among individuals. Although some men might not experience any symptoms, typical signs may include the presence of blood in the urine or semen, painful ejaculation, discomfort or a burning sensation during urination, and various other related symptoms. The primary diagnostic method involves prostate-specific antigen (PSA) testing, which detects elevated PSA levels in individuals affected by prostate cancer or other prostate-related conditions. Screening processes may also include a digital rectal exam to identify any notable prostate tumors, alongside additional methods such as prostate ultrasound and MRI scans. However, a conclusive diagnosis typically necessitates a transrectal ultrasound-guided (TRUS) prostate tissue biopsy. Metastatic Prostate Cancer Epidemiology Segmentation As per DelveInsight analysis, the United States had the highest number of diagnosed prostate cancer cases in 2022, with approximately 2.9 million reported cases. In 2022, total cases of metastatic CSPC/HSPC and metastatic CRPC were around 100K and 120K, respectively, in the 7MM. These cases are expected to increase by 2032. The metastatic prostate cancer market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalent Cases of Prostate Cancer Total Diagnosed Cases of Prostate Cancer Age-Specific Cases of Prostate Cancer Total Diagnosed Cases of Prostate Cancer by Clinical Stages Total Metastatic Cases of Prostate Cancer Total Treated Cases of mCRPC Total Treated Cases of mCSPC Metastatic Prostate Cancer Treatment Market Metastatic Castration-Resistant Prostate Cancer (mCRPC) is a stage of prostate cancer that has spread to other parts of the body, such as lymph nodes or bones, and no longer responds to treatment that lowers testosterone. Despite currently approved therapeutics, mCRPC remains a terminal diagnosis with an aggressive disease course. ADT is a stalwart therapy for the initial treatment of metastatic disease. Unfortunately, most men in this situation will go on to develop mCRPC and require secondary systemic therapy. This disease state can be very challenging to treat. Docetaxel was the only agent available for the treatment of mCRPC until 2010, which showed an increase in overall survival compared with the standard of care. It was approved in 2004 for mCRPC with prednisone. Patients failed to first-line docetaxel for many years, and no standard treatment option was approved. However, in the last few years, several drugs such as JEVTANA, ZYTIGA, XTANDI, LYNPARZA, TALZENNA, AKEEGA, and others have received regulatory approval for mCRPC in the United States. Most recently, PARP inhibitors have shown tremendous development in this area with AKEEGA (Janssen), followed by TALZENNA (Pfizer/Astellas Pharma) and LYNPARZA in combination (AstraZeneca/Merck) getting approved in mCRPC in 2023. The approval of PLUVICTO has also marked a crucial advancement in treating progressive mCRPC, offering improved survival rates for those with limited treatment options. The drug had an exceptionally robust initial market performance, garnering a stronger-than-expected uptake in the US. Quantitatively, the mCRPC pipeline seems to be quite strong. ADCs such as MGC018 and DS-7300 have both displayed encouraging results in clinical trials involving patients with mCRPC. However, except for Point Biopharma's therapy, none of these potential players have initiated a Phase III trial, even though Arvinas plans to opt for an accelerated approval based on its Phase II data readout. Metastatic Castrate-Sensitive Prostate Cancer (mCSPC) is an advanced form of cancer in which cancer cells have spread from the prostate to other body areas. However, the patient is still sensitive to androgen deprivation therapy (ADT) (some mCSPC patients have never had ADT, while others may have had ADT but have recovered testicular function). The backbone of all treatments in mCSPC is androgen deprivation therapy (ADT) with medications that suppress the level of testosterone in the body because testosterone is the fuel for prostate cancer and gives the signals to grow and spread. Studies over the last decade have demonstrated that intensification of androgen deprivation with different treatment modalities correlates with prolongation of survival. The options for intensification include docetaxel chemotherapy, different androgen receptor-targeted agents, including abiraterone acetate, apalutamide, and enzalutamide, and radiation to the prostate. Most recently, the treatment paradigm for mHSPC shifted to triplet therapy, NUBEQA combined with ADT and chemotherapy. According to the findings presented at the ASCO GU 2023, the regimen should be considered the new standard of care for this patient population. To know more about metastatic prostate cancer treatment guidelines, visit @ Metastatic Prostate Cancer Management Metastatic Prostate Cancer Pipeline Therapies and Key Companies Capivasertib (AZD 5363): AstraZeneca Bavdegalutamide (ARV-110): Arvinas MVI-816 (pTVG-HP): Madison Vaccines PT-112: Phosplatin Therapeutics HC-1119: Hinova Pharmaceuticals OPDIVO (nivolumab): Bristol Myers Squibb KEYTRUDA (Pembrolizumab/MK-3475): Merck MGC018 (vobramitamab duocarmazine): MacroGenics DS-7300: Daiichi Sankyo Ceralasertib: AstraZeneca Ladiratuzumab vedotin: Seagen/Merck BMS-986218: Bristol-Myers Squibb TAS-115: Taiho Pharmaceutical ModraDoc006/r: Modra Pharmaceuticals Vudalimab: Xencor (Lu-177) - PNT2002: Point Biopharma LNTH-1095 (MIP-1095): Lantheus Holdings ZEN-3694: Zenith Epigenetics EPI-7386: Essa Pharma 177Lu-DOTA-rosopatamab: Telix Pharmaceuticals Proxalutamide: Kintor Pharmaceutical Masitinib: AB Science VERZENIO (Abemaciclib/LY2835219): Eli Lilly and Company CABOMETYX (cabozantinib): Exelixis Learn more about the FDA-approved drugs for metastatic prostate cancer @ Drugs for Metastatic Prostate Cancer Treatment Metastatic Prostate Cancer Market Dynamics The dynamics of the metastatic prostate cancer are expected to change in the coming years. Before 2010, docetaxel was the primary therapeutic option for metastatic castration-resistant prostate cancer (mCRPC), demonstrating improved overall survival compared to the established standard of care. Its approval in 2004, alongside prednisone, marked a milestone in mCRPC treatment. Following initial docetaxel therapy failure, patients faced a dearth of approved second-line treatments for numerous years. However, recent years have witnessed regulatory approvals of multiple drugs in the United States for mCRPC, transforming the treatment landscape. Notably, medications such as JEVTANA, ZYTIGA, XTANDI, LYNPARZA, TALZENNA, AKEEGA, and several others have gained approval. Of late, significant advancements have emerged in the realm of mCRPC, particularly with PARP inhibitors. AKEEGA from Janssen, TALZENNA jointly developed by Pfizer and Astellas Pharma, and the combination of LYNPARZA by AstraZeneca and Merck garnered approval in 2023, showcasing remarkable progress in this domain. PLUVICTO's approval is a significant leap forward in the management of progressive metastatic castration-resistant prostate cancer, bringing improved survival rates to patients with limited treatment alternatives. The drug witnessed an exceptional and robust initial performance in the US market, exceeding expectations. In numerical terms, the pipeline for metastatic castration-resistant prostate cancer appears robust. Antibody-drug conjugates like MGC018 and DS-7300 have demonstrated promising outcomes in clinical trials among mCRPC patients. Nevertheless, except for Point Biopharma's treatment, the majority of these prospective treatments have yet to commence a Phase III trial. Despite this, Arvinas intends to pursue an expedited approval pathway leveraging its Phase II data for regulatory approval. Scope of the Metastatic Prostate Cancer Market Report Therapeutic Assessment: Metastatic Prostate Cancer current marketed and emerging therapies Metastatic Prostate Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging Metastatic Prostate Cancer Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Metastatic Prostate Cancer Market Access and Reimbursement Discover more about metastatic prostate cancer drugs in development @ Metastatic Prostate Cancer Clinical Trials Table of Contents Related Reports Prostate Cancer Epidemiology Forecast Prostate Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and prostate cancer epidemiology trends. Metastatic Prostate Cancer Pipeline Metastatic Prostate Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key metastatic prostate cancer companies, including AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, Seagen, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis , among others. Metastatic Castration-Resistant Prostate Cancer Market Metastatic Castration-Resistant Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic castration-resistant prostate cancer companies including AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, Seagen, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis among others. Metastatic Hormone-Refractory Prostate Cancer Pipeline Metastatic Hormone-Refractory Prostate Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key metastatic hormone-refractory prostate cancer companies, including AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, Seagen, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +91-9650213330 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3Drug ApprovalClinical ResultPhase 2

100 Deals associated with Cabazitaxel Acetone

External Link

KEGG	Wiki	ATC	Drug Bank
D09755	Cabazitaxel Acetone	L01CD04	DB06772

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Prostatic Cancer	JP	Sanofi KK	04 Jul 2014
Metastatic castration-resistant prostate cancer	US	Sanofi-Aventis U.S. LLC	17 Jun 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 3	FR	Sanofi	01 Dec 2013
Localized Prostate Carcinoma	Phase 3	FR	Sanofi	01 Dec 2013
Transitional Cell Carcinoma	Phase 3	GB	Sanofi	01 Jan 2013
Castration-Resistant Prostatic Cancer	Phase 3	US	Sanofi (China) Investment Co. Ltd.	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	US	Sanofi-Aventis Recherche et Développement SA	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	US	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	JP	Sanofi-Aventis Recherche et Développement SA	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	JP	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	JP	Sanofi (China) Investment Co. Ltd.	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	DK	Sanofi-Aventis Recherche et Développement SA	05 May 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03419234 (CHAARTED2, ASCO2024) Manual	Phase 2	Castration-Resistant Prostatic Cancer Second line	223	Abiraterone+prednisone+cabazitaxel	bzgbnzznra(mdajqtihxc) = rrrcdbnoyj njyqdxqeiv (fpztinybgj, 9.9 - 18.6) View more	Negative	02 Jun 2024
				Abiraterone+prednisone	bzgbnzznra(mdajqtihxc) = wnqgwxccby njyqdxqeiv (fpztinybgj, 7.0 - 12.6) View more
NCT03381326 (ASCO2024)	Not Applicable	Metastatic castration-resistant prostate cancer Circulating Subclonality Index (CSI)	104	Cabazitaxel	keuzpkdhzi(usphfidfmb) = wbkkbdvyph grxdbndmqr (zjqggnowjy, 2.3 - 4.4) View more	-	24 May 2024
NCT02903160 (CTgov)	Phase 2	Castration-Resistant Prostatic Cancer	40	Radium-223 dichloride+Enzalutamide+Cabazitaxel+Carboplatin+Prednisone+Abiraterone acetate	holkibmwzy(sebgxwxlru) = ysfbjdakfz rdxgjpbevt (tnehuemqqh, txmgmmkrwy - steztkavzb) View more	-	07 Feb 2024
ASCO_GI2024 Manual	Phase 1/2	Esophageal Carcinoma	15	DEP cabazitaxel 20 mg/m2	njrantepyg(maaewdmtli) = mtspkfufhn obpgunfyzi (mogrxbpcin ) View more	Positive	18 Jan 2024
				DEP cabazitaxel 20 mg/m2 (EG ADENOCA pts)	njrantepyg(maaewdmtli) = ubywenogaf obpgunfyzi (mogrxbpcin ) View more
NCT03903835 (ProBio, ESMO2023) Manual	Phase 3	Castration-Resistant Prostatic Cancer First line	219	abiraterone or enzalutamide (Androgen receptor pathway inhibitors (ARPi))	yxebqxiwsn(rnebxitihn) = vcgtosgdtq odtobrqofx (xnmobwywgr, 9.8 ～ 13.1) View more	Positive	22 Oct 2023
				docetaxel or cabazitaxel (Taxanes)	oookliebqy(wyifhlsajc) = bsmbqwrdpd cqtvbtdugd (lrcpmmvmzo, 18.4 ～ 23.0)
NCT03295565 (OSTRICH, ESMO2023) Manual	Phase 2	Castration-Resistant Prostatic Cancer	106	Cabazitaxel	fvxhdiawpu(sfmmepgjbx) = wwpnhoqxup ixwwlfxmrq (nhtuhebilq, 46.1-74.2) View more	Non-superior	22 Oct 2023
				Abiraterone or Enzalutamide	fvxhdiawpu(sfmmepgjbx) = mvdluvfjww ixwwlfxmrq (nhtuhebilq, 52.9-79.7) View more
NCT03381326 (ESMO2023) Manual	Not Applicable	Metastatic castration-resistant prostate cancer PIK3CB \| AKT1	97	Cabazitaxel (ctDNA fraction at C3 vs BL)	zbmvlgaqer(qkknthnqtt) = kiobjxkzqq sxjjooqsds (wwzgusgdra, 2.2-3.1) View more	Positive	22 Oct 2023
				Cabazitaxel (pts who had a decrease at C3)	zbmvlgaqer(qkknthnqtt) = nmpeedtumh sxjjooqsds (wwzgusgdra, 5.1-8.2) View more
NCT04495179 (AARDVARC, CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	30	AZD4635+Durvalumab (Arm A: AZD4635 + Durvalumab)	kptmasdmje(ugrypnqfse) = depqftlump clphfsuads (gmfdetywmo, abjwnvtslo - vihowduhtn) View more	-	09 Aug 2023
				Cabazitaxel+AZD4635+Durvalumab (Arm B: AZD4635 + Durvalumab + Cabazitaxel)	romciuimvk(abfxgziedn) = oyzwbflasj vftmksinwz (wbkinwfcyg, smdfaxbjbs - dxwwzxxrzb) View more
NCT01616875 (ASCO_GU2023) Manual	Phase 2	Urothelial Carcinoma of the Urinary Bladder	26	Cabazitaxel + Cisplatin	nxbvenrvun(qmpzrrtmez) = grxndgfnyd zznkfutpay (hauxkymhnv ) View more	Positive	21 Feb 2023
				Cabazitaxel + Cisplatin (achieved ORR)	itdkbidsak(leyoqmwyva) = xndexfcnux xrrzlbwmlb (ntnpzzflhz )
Pubmed Manual	Phase 2/3	HER2-negative breast cancer First line HER2 Negative	158	cabazitaxel	wevroiwmri(slgdjzadyj) = qmmgzefsac pnfmkbjzhh (dhzkctvmbb ) View more	Negative	24 Sep 2022
				paclitaxel	wevroiwmri(slgdjzadyj) = blnhrfeqhg pnfmkbjzhh (dhzkctvmbb ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis