Apalutamide in Hormone-dependent prostate cancer: NCT07751133 Clinical Landscape Report 2026
Explore the PatSnap Life Sciences MCP marketplace
This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 16 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 3
Clinical phase
Recruiting
Recruitment status
1500
Planned enrollment
2029-08-01
Primary-completion proxy
Executive view
NCT07751133 evaluates Apalutamide in Hormone-dependent prostate cancer. The disclosed sponsor is University College London, the design is Interventional, and the geographic footprint is United Kingdom. The first listed primary endpoint is Overall survival (primary efficacy), assessed over From randomisation up to 6 years (or date last known to be alive) or date of death, whichever occurs first..
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07751133 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Hormone-dependent prostate cancer landscape. Drug & Asset MCP drug_fetch was queried for Apalutamide, while Company & Deal Intelligence MCP organization_fetch was queried for University College London.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07751133 | Apalutamide | Phase 3 / Recruiting | University College London | United Kingdom | Overall survival (primary efficacy) From randomisation up to 6 years (or date last known to be alive) or… | 2029-08-01 |
| NCT07793435 | Fludarabine Phosphate | Phase 1/2 / Not yet recruiting | ADICET THERAPEUTICS INC | United States | The incidence of Subjects with Dose Limiting Toxicity within each dose level Day 42 | 2028-10-01 |
| NCT07783282 | Enzalutamide | Phase 1 / Not yet recruiting | Astellas Pharma Global Development, Inc. | Geography not reported | Pharmacokinetics (PK) of Fezolinetant in plasma: Maximum Concentration (Cmax) Up to Day 3 | 2027-04-30 |
| NCT07765940 | 64Cu-RAX301 | Phase 1/2 / Not yet recruiting | RadAlliance Therapeutics, Inc. | Geography not reported | The safety and tolerability of [⁶⁴Cu]Cu-RAX301 Injection - Phase 1 From administration of [⁶⁴Cu]Cu-RAX301 through Day 7 ± 2 days | 2027-06-30 |
| NCT07756593 | Nogapendekin alfa inbakicept-pmln | Phase 1 / Not yet recruiting | Washington University School of Medicine | United States | Frequency of dose-limiting toxicities (Cohort 1 only) Start of treatment (day 1 dose of Sip-T) through 14 days following th… | 2029-04-14 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
Reproduce the trial-to-asset workflow with PatSnap MCP
Protocol design and endpoint interpretation
NCT07751133 is a Phase 3, recruiting study with 1500 planned participants. Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment.
The primary endpoint is “Overall survival (primary efficacy)” over “From randomisation up to 6 years (or date last known to be alive) or date of death, whichever occurs first..” The retrieved endpoint description is: Overall survival, defined as the time from date of randomisation to date of death from any cause, and those who are alive are censored at the date last known to be alive. This will be assessed for non-inferiority using a margin for the absolute risk difference at 2 years of ≤4 percentage points, between reduced and standard dose ARPI arms. A hierarchical approach will be applied to all 3 primary outcome measures, in which each analysis (in turn) should yield a p-value of \<0.05 in the following ranked order: 1. Non-inferiority for overall survival 2. Superiority of a mean difference in QoL fatigue score (expecte….
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 1500 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
The protocol identifies Apalutamide, Abiraterone acetate as control therapy. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Hormone-dependent prostate cancer. These records do not establish direct evidence for NCT07751133 unless the registration number matches.
PLATI-PARP: A Phase 2 Study of Induction Docetaxel and Carboplatin Followed by Maintenance Rucaparib in Treatment of Patients With Metastatic Castration Resistant Prostate Cancer…
Phase 2; n=18; Radiographic Progression Free Survival Assessed by Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1/Prostate Cancer Working Group 3 (PCWG3) Criteria(Median) = 8.1 Months (95% Confidence Interval, 6.5 - 31.2) Source: https://clinicaltrials.gov/ct2/show/results/NCT03442556
Open-label Study of Androgen Receptor Inhibition With dArolutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Men With Metastatic Hormone-Sensitive Prostate Cancer Usin…
Phase 2; n=223; PFS(Median): Hazard Ratio (HR) = 0.29(95% CI, 0.20 - 0.40), P-Value = <0.001; PFS(Median) = 14.3 Months (95% Confidence Interval, 11.20 - 17.38) Source: https://clinicaltrials.gov/ct2/show/results/NCT05059236
A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients W…
Phase 3; n=1012; rPFS(Median) = 33.2 Months (95% Confidence Interval, 25.8 - 44.2); rPFS(Median): Hazard Ratio (HR) = 0.81(95% CI, 0.66 - 0.98), P-Value = 0.034 Source: https://clinicaltrials.gov/ct2/show/results/NCT04493853
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Apalutamide is indexed as Small molecule drug with AR biology and a global stage of Approved. The asset profile lists Janssen Global Services LLC as an originator or developer.
University College London is indexed in United Kingdom with the website http://www.ucl.ac.uk. UCL is one of the world's leading universities, founded in London to open up education to all on equal terms. The record lists 62 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Apalutamide is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07751133
Protocol source: https://clinicaltrials.gov/study/NCT07751133
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 16 September 2026.
Apalutamide in Hormone-dependent prostate cancer is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Overall survival (primary efficacy) and 2029-08-01 the leading decision points.
Build and refresh clinical landscape reports with PatSnap MCP
