DAROSTEP: Evaluating Step Counts as a Biomarker and Its Relationship on Treatment Outcomes in Vulnerable Patients With Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy

This prospective clinical trial aims to investigate the impact of darolutamide in combination with standard-of-care androgen deprivation on physical activity, specifically step count, and its correlation with important markers of safety in vulnerable adults who screen positive by a brief geriatric assessment (GA) and metastatic hormone-sensitive prostate cancer.

Start Date01 Nov 2026

Sponsor / Collaborator

The University of Chicago

NCT07450599

/ Not yet recruitingPhase 2

CHINANEO: A China Phase 2, Open-Label, Randomized, Multicenter Study to Investigate the Efficacy and Safety of Darolutamide + ADT as Neo-Adjuvant Treatment for 12 Weeks vs 24 Weeks in Treatment-Naïve Participants Who Have Planned for Radical Prostatectomy (RP) With High-Risk Localized Prostate Cancer

Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make it more likely to grow and spread.
The study treatment darolutamide plus androgen deprivation therapy (ADT) is under development as treatment before surgery for men who have high-risk localized prostate cancer. Darolutamide works by blocking the attachment of androgen hormones to androgen receptors in cancer cells, thereby blocking cancer progression and growth. ADT is an established treatment that is used to lower the amount of androgen hormones (e.g., testosterone) in the body.
The main purpose of this study is to learn how the cancer responds to the two different treatment durations (12 weeks or 24 weeks) of darolutamide combined with ADT used before the men undergo surgery to remove the prostate. For this, the researchers will compare the percentage of participants who either achieve complete response to the treatment (where no cancer cells are found) or with condition of minimal residual disease after the treatment (where only a small amount of cancer cells remains).
The study participants will be randomly (by chance) assigned to one of two treatment groups. Depending on the group, they will receive darolutamide tablets by mouth plus ADT administered under the skin for either 12 weeks or 24 weeks. No more than 30 days after the end of the treatments, study participants will be performed with surgery to remove the prostate.
Each participant will be in the study for approximately 29 to 32 months, including a screening phase of up to 28 days, 12 weeks or 24 weeks of treatment depending on the treatment groups, followed by the surgery no more than 30 days after the treatment, and a follow up phase of up to 2 years after the surgery.
2 visits to the study site are planned during the screening phase, followed by 3 to 6 visits (every 28 days) during treatment. The treatment period ends with a visit within 7 days after the last dose of treatment.
During the study, the doctors and their study team will:
* take blood and urine samples
* check the participants' health parameters
* do physical examinations
* check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan
* take tumor samples
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
About 30 days after the last dose of treatment, 5 weeks after the surgery and every 12 weeks thereafter, the study doctors and their team will check the participants' health and any changes in cancer. This follow-up period ends 2 years after the surgery.

Start Date15 Apr 2026

Sponsor / Collaborator

Bayer AG

NCT07476677

/ Not yet recruitingPhase 2IIT

A Phase II Prospective, Open-Label Clinical Study of Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer

This is a two-Parallel cohort, prospective study, aimed to explore Efficacy and safety of neoadjuvant Darolutamide with or without ADT in high-risk/very high-risk localized-stage prostate cancer. Two parallel cohorts will enroll 30 patients with high-risk/very high-risk localized-stage prostate cancer according to the criteria, respectively. Eligible patients in cohort 1 will receive 600 mg of Darolutamide orally daily, and patients in cohort 2 will receive 600 mg of Darolutamide orally daily combined with ADT. The selection of the two parallel cohorts will be determined by the clinician. Considering that ADT treatment will bring typical adverse-reactions such as hot flashes, gynecomastia, fatigue, and sexual dysfunction, the clinician will decide the enrollment cohort based on the patient's specific clinical condition. After both cohorts receive 3-6 months of neoadjuvant treatment, these patients will receive robotic-assisted laparoscopic prostatectomy (RALP) ± standard lymph node dissection (LND), and the specific surgical plan will be formulated by the clinician. Patients will receive postoperative adjuvant therapy as same as the original prescription according to different conditions (the application of postoperative adjuvant radiotherapy is determined by the clinician). Follow-up: (1) PSA and testosterone levels: Monitor monthly for the first 6 months. Monitor every 3 months within 2 years. Monitor every 6 months thereafter. (2) Radiological evaluation: Monitor every 6 minutes within 2 years after surgery, and every 12 minutes thereafter.

Start Date01 Apr 2026

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

100 Clinical Results associated with Darolutamide

100 Translational Medicine associated with Darolutamide

100 Patents (Medical) associated with Darolutamide

509

Literatures (Medical) associated with Darolutamide

01 Apr 2026·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Progression-free survival with darolutamide and docetaxel vs. androgen receptor pathway inhibitors vs. docetaxel in metastatic hormone-sensitive prostate cancer: A real-world multicenter retrospective study

Article

Author: Schlack, Katrin ; Seitz, Anna Katharina ; Kappler, Paula ; Darr, Christopher ; Schnabel, Marco J ; Cathomas, Richard ; Paffenholz, Pia ; Steinestel, Julie ; Müller, Marten ; Unland-Gies, Daniel ; Rinderknecht, Emily ; Burger, Maximilian ; Richter, Julika ; Bielstein, Gloria ; Breyer, Johannes ; Heidegger, Isabel ; Bastian, Julius L D

BACKGROUND AND OBJECTIVE:

In metastatic hormone-sensitive prostate cancer (mHSPC), first-line treatment with either docetaxel + androgen deprivation therapy (ADT) or androgen receptor pathway inhibitors (ARPI) + ADT represented the standard of care. Triplet therapy (docetaxel + ARPI + ADT) has shown superiority over docetaxel + ADT, leading to regulatory approval. However, real-world data directly comparing ARPI + ADT and triplet therapy are lacking. This study evaluates real-world outcomes across 3 treatment regimens using inverse probability of treatment weighting (IPTW).

METHODS:

We retrospectively analyzed data from 13 centers of men with mHSPC treated with docetaxel + ADT, ARPI (apalutamide or enzalutamide) + ADT, or darolutamide + docetaxel + ADT. The primary endpoint was progression-free survival (PFS); secondary endpoints included adverse events. To address baseline imbalances, IPTW was employed. Time-to-event data were analyzed using weighted Cox proportional hazards regression with robust variance estimation.

RESULTS:

After excluding incomplete cases, 346 men were analyzed: 58 (16.8%) received docetaxel + ADT, 203 (58.7%) ARPI + ADT, and 85 (24.6%) triplet therapy. Before weighting, triplet patients demonstrated more adverse baseline features. After achieving covariate balance through IPTW adjustment, no significant differences in PFS were observed, with hazard ratios of 1.60 (95% CI: 0.78-3.28, P = 0.20) for docetaxel + ADT and 0.70 (95% CI: 0.36-1.35, P = 0.29) for ARPI + ADT compared to triplet therapy. Grade ≥3 adverse events occurred in 36.2%, 10.9%, and 31.8% of patients, respectively (P < 0.001).

CONCLUSIONS:

In this IPTW-adjusted real world cohort, triplet therapy was not significantly associated with improved PFS compared to ARPI + ADT or docetaxel + ADT. These findings should be interpreted in the context of limited sample size and follow-up, and further prospective studies are warranted.

01 Mar 2026·Biomaterials advances

PEGylated liposomes co-encapsulating darolutamide and hesperetin for enhanced prostate cancer therapy: 2D, 3D PC3 models and in-vivo evaluation

Article

Author: Khemchandani, Rahul ; Pawar, Avinash ; Pardhi, Ekta ; Mehra, Neelesh Kumar ; Smanthula, Gananadhamu ; Patil, Ruchita

In this study, a darolutamide and hesperetin co-loaded PEGylated liposomal formulation (DHLP) was developed for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). The formulation was prepared using the ethanol injection method, followed by membrane extrusion through a 100 nm polycarbonate filter to ensure size uniformity. The optimized DHLP liposomal formulation exhibited a clear bluish appearance, with a mean particle size of 106.5 ± 3.2 nm, a polydispersity index of 0.128 ± 0.023, and a zeta potential of -14.10 ± 0.25 mV, indicating colloidal stability and uniformity. Spherical morphology was confirmed through microscopic analysis. High encapsulation efficiencies were achieved for both DA (90.1 ± 3.3 %) and HE (91.3 ± 2.7 %). For both medication, in vitro drug release experiments showed a sustained release profile from the DHLP. Cytotoxicity assessment in PC3 prostate cancer cells revealed a 2.83-fold increase in cytotoxicity compared to free DA solution, a 3.89-fold increase compared to free HE solution, and a 1.47-fold improvement over the combined DA-HE solution. The combination index value of 0.89 confirmed synergistic anticancer activity. DHLPs inhibited cell migration, increased ROS generation, and reduced 3D spheroid size, with enhanced cellular uptake contributing to improved therapeutic efficacy. In-vivo pharmacokinetic studies in BALB/c mice demonstrated a 1.7- and 3.4-fold increase in the plasma half-life of DA and HE, respectively, compared to their free drug solutions. Biodistribution studies revealed reduced accumulation of DHLP in vital organs compared to the free drug solution. Acute toxicity assessment at three dose levels showed no histopathological alterations, indicating a favorable safety profile. These results imply that DHLP is a potential nanocarrier system for the effective management of prostate cancer.

01 Mar 2026·EUROPEAN JOURNAL OF CANCER

Use of concomitant G-CSF in maintaining efficacious dose and safe delivery of docetaxel in combination with darolutamide in ARASENS: A phase III study

Article

Author: Verholen, Frank ; Tombal, Bertrand ; Hussain, Maha ; Fizazi, Karim ; Ong, Michael ; Lalani, Aly-Khan A ; Smith, Matthew ; Suzuki, Hiroyoshi ; Srinivasan, Shankar ; Saad, Fred ; Pham, Ha

BACKGROUND:

We assessed the impact of granulocyte colony-stimulating factor (G-CSF) use and docetaxel relative dose intensity (RDI) on the safety profile of the ARASENS (NCT02799602) triplet regimen with darolutamide in patients with metastatic hormone-sensitive prostate cancer.

METHODS:

Patients were randomized to darolutamide 600 mg orally twice daily or placebo, with androgen deprivation therapy (ADT) and docetaxel. Baseline characteristics, G-CSF use, and safety were analyzed according to docetaxel RDI (≤85 % vs >85 %).

RESULTS:

Of 1273 patients with docetaxel RDI data (darolutamide n = 637; placebo n = 636), > 97 % received an efficacious dose of docetaxel (RDI >80 %). Patient demographics and baseline disease characteristics were generally similar between RDI subgroups; > 60 % of patients with RDI ≤ 85 % were from the Asia-Pacific region. Concomitant G-CSF, with/without docetaxel dose modification, was used in 42.4 % (darolutamide) and 44.6 % (placebo) of patients, mainly as secondary prophylaxis; 61.3 % (darolutamide) and 64.4 % (placebo) received both docetaxel dose modifications and G-CSF. Grade ≥ 3 treatment-emergent adverse events (TEAEs), grade ≥ 3 neutropenia, and grade ≥ 3 febrile neutropenia were higher with docetaxel RDI ≤ 85 %, but docetaxel discontinuation rates were similar between subgroups (RDI ≤85 %: darolutamide 7.2 %, placebo 10.8 %; RDI >85 %: darolutamide 8.1 %, placebo 10.5 %). TEAEs leading to docetaxel dose modification were more frequent with docetaxel RDI ≤ 85 % (darolutamide 92.8 %; placebo 97.3 %) versus RDI > 85 % (darolutamide 26.0 %; placebo 25.3 %).

CONCLUSION:

Appropriate docetaxel dose modifications and early G-CSF use allowed almost all patients to receive an efficacious dose of docetaxel in combination with darolutamide and ADT and may prevent neutropenic complications in patients receiving docetaxel.

PRIOR PRESENTATION:

Previously presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium, San Francisco, CA.

271

News (Medical) associated with Darolutamide

01 Apr 2026

·www.fiercebiotech.com

Oric chases Pfizer into phase 3 hailing prostate cancer edge, but investors send stock down

Oric plans to start a phase 3 trial in the first half of the year.\n Oric Pharmaceuticals has picked the phase 3 dose for its prostate cancer prospect, barreling into the pivotal program while outlining a claimed edge over Pfizer’s rival candidate. But investors sent the stock down as they digested Oric’s phase 1b data and choice of pivotal treatment regimen.The phase 3 trial, which will start in the first half of the year, will test 400 mg, once-daily doses of Oric’s PRC2 inhibitor rinzimetostat in combination with Bayer’s Nubeqa in metastatic castration-resistant prostate cancer patients previously treated with abiraterone. At an interim phase 1b analysis, 33% of patients on the regimen had at least a 50% decline in prostate-specific antigen (PSA). Oric reported a 40% rate of PSA50 across all doses in November. California-based Oric reported an 84% radiographic progression-free survival (rPFS) rate after five months. The company said the rPFS results were consistent with Pfizer’s rival EZH2 inhibitor, mevrometostat, and better than standard-of-care therapies, including Novartis’ Pluvicto.On a call with investors to discuss the results, Oric Chief Medical Officer Pratik Multani, M.D., said the biotech chose 400 mg, not 600 mg, for the phase 3 dose after seeing no statistical relationship between exposure and efficacy. The 400 mg dose performed numerically better than the 600 mg dose on some measures, Multani said, and the confidence intervals overlapped. While the efficacy data suggested the doses are comparable, the safety and tolerability results pointed to a clear advantage for 400 mg. Oric saw more toxicity and dose modifications at the 600-mg dose, leading it to advance the lower dose into phase 3. Citi analysts called the choice of dose “logical” in a note to investors.Safety and tolerability are key to Oric’s plans. Pfizer has taken mevrometostat into phase 3 based on data that suggest it matches rinzimetostat’s efficacy. Lagging behind its rival, Oric sees mevrometostat’s rates of gastrointestinal and hematological adverse events, plus cases of dysgeusia and alopecia, as areas to gain an edge. Oric CEO Jacob Chacko told investors rinzimetostat’s safety profile “looks markedly better.”Another analyst asked about Nubeqa\'s selection as a phase 3 combination drug. Oric also studied its candidate with Johnson & Johnson’s Erleada. Like Nubeqa, Erleada is an androgen receptor inhibitor. Chacko said Oric chose Nubeqa to avoid the drug-drug interactions associated with Erleada, adding that the company could combine rinzimetostat with J&J’s product in future phase 3 studies. Oric shares were trading down 24% to $9.60 in the first hour of trading Wednesday, compared to a Tuesday closing price of $12.67. Citi analysts said the stock drop could reflect confusion about the choice of the 400-mg dose or “possibly misguided expectations of greater efficacy” compared to mevrometostat. While Pfizer’s candidate is leading the race, the analysts said the safety data support Oric’s belief that rinzimetostat can claim a substantial share of the post-abiraterone market.

Phase 3Clinical ResultPhase 1Phase 2

01 Apr 2026

·endpoints.news

Oric to advance prostate cancer drug to Phase 3, but combo choice raises doubts

Oric Pharmaceuticals on Tuesday detailed its plans to advance a PRC2 inhibitor into a registrational program for prostate cancer after sharing results from a Phase 1b trial. But the company’s shares $ORIC dropped by as much as 25% before market open Wednesday as investors had reservations about the biotech’s choice of androgen receptor inhibitor it will combine the investigational drug with. Oric said it plans to advance its candidate, known as rinzimetostat, and Bayer’s Nubeqa into a Phase 3 study. The trial will enroll 600 patients with metastatic castration-resistant prostate cancer (mCRPC) across more than 20 countries. It is set to start in the first half of this year. Jefferies analysts wrote Wednesday that the negative stock move might be due to onlookers thinking that Johnson & Johnson’s Erleada would have been a “better fit strategically” than Nubeqa. Results from a recent head-to-head real-world analysis show Erleada cut the risk of death by 51% compared with Nubeqa in certain prostate cancer patients, although they aren’t the same ones Oric is targeting. Oric’s early-phase trial recruited mCRPC patients who had a median two prior lines of therapy, including previous treatment with abiraterone. The analysts wrote that Oric decided to opt for Nubeqa because it has a lower risk of drug-drug interactions with the investigational drug compared with Erleada. Oric’s choice of combination approach was also based on data from the Phase 1b trial, which tested two different doses of rinzimetostat with Nubeqa, but also with Erleada. The Tuesday release did not report data with Erleada. Results from the Phase 1b trial also led to Oric choosing the lower dose (400 mg) of rinzimetostat versus a higher one (600 mg). The company said that the higher dose was associated with a “modestly higher rate of adverse events.” The most common side effects at the lower dose were fatigue, diarrhea and nausea. There were no grade 4 or 5 events associated with the regimen. The company added both doses had “comparable efficacy,” although the Tuesday data were not split by dose level. Of the 18 evaluable patients treated with the investigational combo of rinzimetostat and Nubeqa, 84% were still alive with no disease progression at five months with a median follow-up of 4.9 months. With the caveat of cross-trial comparison, the Tuesday data are “consistent with” the results attained by Pfizer’s candidate, called mevrometostat, in combination with Xtandi in a Phase 3 trial, despite Oric patients being more heavily pretreated, the Jefferies analysts said. Both rinzimetostat and mevrometostat inhibit the PRC2 complex, but via different subunits — rinzimetostat targets EED, while mevrometostat acts on EZH2. Editor’s note: This story was updated to clarify drug mechanisms.

Phase 3Phase 1Phase 2Clinical Trial TerminationClinical Result

01 Apr 2026

·firstwordpharma.com

ORIC details Phase III prostate cancer plans for PRC2 inhibitor

ORIC Pharmaceuticals said Tuesday it will start a registrational study this half for its experimental metastatic castration-resistant prostate cancer (mCRPC) treatment, rinzimetostat (formerly ORIC-944), as it looks to best a potential rival from Pfizer. The pharma is developing mevrometostat, an EZH2 inhibitor, also for mCRPR. Last year, Phase I data showed mevrometostat reduced the risk of progression or death by 49% when combined with Xtandi (enzalutamide) in patients with mCRPC, which analysts at the time called "very positive" for ORIC. The biotech's rinzimetostat is an allosteric inhibitor of PRC2, a chromatin modifying enzyme complex whose subunits include EZH2 and EED, the latter of which ORIC's compound binds to.While ORIC reported seemingly positive Phase Ib data for rinzimetostat to justify its move into Phase III testing, the company's shares plummeted 41% on Wednesday — though some investors questioned the drastic drop's rationale. "We’re not sure why the stock is selling off," Oppenheimer analysts wrote in a note. "The efficacy looks competitive to mevrometostat."ORIC said in a company release that the early efficacy data are "suggestive of meaningful and durable clinical benefit…compared to competitor data and historical outcomes with approved therapies."Survival and safety dataThe early-stage study evaluated 400-mg and 600-mg once-daily doses of rinzimetostat in combination with an AR inhibitor, either Johnson & Johnson's Nubeqa (darolutamide) or Bayer’s Erleada (apalutamide). An exposure-response analysis showed that the two dose levels had comparable efficacy, but it "identified statistically significant relationships between higher drug exposure and toxicities as well as increased rates of treatment modifications, clearly favouring the 400-mg dose on the basis of safety." As a result, ORIC has selected the 400-mg dose of rinzimetostat in combination with the standard, 600-mg twice daily dose of Nubeqa as the recommended Phase III dose. The drugmaker on Tuesday shared data from the 18 patients who received that specific cocktail in the Phase Ib trial.After a median follow-up of 4.9 months, patients achieved "landmark" radiographic progression-free survival (rPFS) rates of 93%, 84% and 84% at three, four and five months, respectively. According to ORIC, the results are consistent with data for mevrometostat in post-abiraterone mCRPC patients, and superior standard-of-care therapies.Additionally, in a subset of 15 patients with at least one post-baseline assessment as of the Jan. 16 cutoff, seven patients (47%) achieved a PSA50 response, with five (33%) confirmed responses. ORIC also evaluated molecular responses in 14 patients with detectable circulating tumour DNA (ctDNA) at baseline. In that group, 10 patients (71%) achieved a >50% ctDNA reduction.The findings "provide confirmatory evidence that support rinzimetostat’s potential best-in-disease clinical profile, reinforcing its path towards becoming a practice-changing therapy for patients with prostate cancer," said CEO Jacob M. Chacko in a company release, noting that the candidate demonstrated "a markedly cleaner safety profile than competitor regimens."The Oppenheimer analysts also homed in on the safety data, calling it "the real differentiator." "Most docs we’ve spoken to say mevrometostat has real tolerability issues, driven by diarrhoea and dysgeusia," they wrote. "Rinzimetostat chops those in half." ORIC reported that the most common treatment-released adverse events (TRAEs) in patients receiving the 400-mg dose of rinzimetostat were fatigue (39%), diarrhoea (22%) and nausea (22%). There was one case of a grade 3 TRAE, and no grade 4 or 5 AEs were linked to the treatment regimen. The company is planning to enrol 600 patients with mCRPC patients who were previously treated with abiraterone in the Phase III Himalayas-1 trial, comparing the rinzimetostat-Nubeqa duo against physician’s choice of an AR inhibitor or chemotherapy. The study's primary endpoint will be rPFS, with overall survival as the key secondary measure.

Clinical ResultPhase 3Phase 1

100 Deals associated with Darolutamide

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KEGG	Wiki	ATC	Drug Bank
D11045	Darolutamide	L02BB06	DB12941

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hormone-dependent prostate cancer	European Union	Bayer AG	20 Mar 2023
Hormone-dependent prostate cancer	Iceland	Bayer AG	20 Mar 2023
Hormone-dependent prostate cancer	Liechtenstein	Bayer AG	20 Mar 2023
Hormone-dependent prostate cancer	Norway	Bayer AG	20 Mar 2023
Castration-sensitive prostate cancer	China	Bayer HealthCare Pharmaceuticals, Inc.	16 Mar 2023
Metastatic Prostate Carcinoma	Japan	Bayer AG	24 Feb 2023
Metastatic castration-resistant prostate cancer	United States	Bayer HealthCare Pharmaceuticals, Inc.	05 Aug 2022
Prostatic Cancer	Brazil	Bayer AG	01 Jan 2020
Castration-Resistant Prostatic Cancer	United States	Bayer HealthCare Pharmaceuticals, Inc.	30 Jul 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Localized Prostate Carcinoma	Phase 3	France	Bayer AG	10 Apr 2025
Localized Prostate Carcinoma	Phase 3	Martinique	Bayer AG	10 Apr 2025
Recurrent Prostate Carcinoma	Phase 3	United States	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	China	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Japan	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Australia	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Austria	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Belgium	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Brazil	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Canada	Bayer AG	03 Apr 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02799602 (ARASENS, ASCO_GU2026)	Phase 3	Hormone-dependent prostate cancer	1,305	darolutamide+androgen deprivation therapy+docetaxel	xaalklmkps(osbmyyjqvg) = kkwhnvzuso plofvvidbq (pajcvdvfqo ) View more	Positive	26 Feb 2026
				placebo+androgen deprivation therapy+docetaxel	xaalklmkps(osbmyyjqvg) = ospbhyntvm plofvvidbq (pajcvdvfqo ) View more
NCT05900973 (Daro-PET, ASCO_GU2026)	Phase 2	Localized Prostate Carcinoma	16	Darolutamide 600 mg	scfgkqexwm(lifivfqlvp) = No adverse events were reported, and all patients completed treatment. mzvfpekahg (zoctsmynoe )	Positive	26 Feb 2026
NCT06190899 (ASCO_GU2026)	Phase 1/2	Metastatic castration-resistant prostate cancer	56	Gedatolisib 120 mg + Darolutamide	lkbnemcxkb(asvogmdwzp) = jbhefvgdcu kmrmyiikwl (somuipfsxs ) View more	Positive	26 Feb 2026
				Gedatolisib 180 mg + Darolutamide	cfntjxngvh(ptobkfhacy) = rxvvxwwgac spokliorrl (irnbwxkxcp ) View more
NCT04736199 (ARANOTE, ASCO_GU2026)	Phase 3	Hormone-dependent prostate cancer	669	Darolutamide + ADT	wgvgeqsmui(pjttzjzgps) = phzooxsnyz fddwobqnbo (xjmwkpegbv ) View more	Positive	26 Feb 2026
				Placebo + ADT	wgvgeqsmui(pjttzjzgps) = ijkfcekrmq fddwobqnbo (xjmwkpegbv ) View more
NCT05526248 (ARAMON, ASCO_GU2026)	Phase 2	Castration-sensitive prostate cancer	23	Darolutamide 600 mg	wesnesnxpu(zeqreogdtu) = lzvwqvyxbe mvzrglpyar (ndvyllyvyh ) View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Prostatic Cancer	195	Abiraterone acetate	tvshygbcxl(bzuywuluyf) = apfgymreow rvouyjpysh (nvydetiols ) View more	Negative	26 Feb 2026
				Apalutamide	tvshygbcxl(bzuywuluyf) = llfuttmvku rvouyjpysh (nvydetiols ) View more
ASCO_GU2026	Not Applicable	Castration-Resistant Prostatic Cancer	96	enzalutamide	dgujzhknjh(mljrjdydwq) = uydvogvgmn rzmpkaewqh (gweqmyqyon ) View more	Positive	26 Feb 2026
				apalutamide	dgujzhknjh(mljrjdydwq) = zzitxovdjl rzmpkaewqh (gweqmyqyon ) View more
NCT05526248 (ARAMON, Pubmed \| Eur Urol Focus)	Phase 2	Castration-sensitive prostate cancer \| Non-metastatic prostate cancer	23	Darolutamide 600 mg	vnrveqpunw(crmvduprci) = Most AEs were grade 1/2, including feminizing AEs, occurring mainly during the first 6 months eedxwmerea (hcpobihnxu )	Positive	01 Feb 2026
NCT02200614 (ARAMIS, Pubmed \| Cancer Med)	Phase 3	Castration-Resistant Prostatic Cancer	1,509	Darolutamide + ADT	gzoblpjjci(riiznftwxm): HR = 0.36 (95.0% CI, 0.26 - 0.48) View more	Positive	01 Jan 2026
				Placebo + ADT
ARAMIS (ESMO_ASIA2025)	Phase 3	Castration-Resistant Prostatic Cancer	76	Darolutamide + androgen-deprivation therapy	xfjxtmuzkm(rjongwbkul) = zdippbihuc cqqgpstics (hjzgxgbtew ) View more	Positive	05 Dec 2025

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