Darolutamide in Localized Prostate Carcinoma: NCT07677566 Clinical Landscape Report 2026
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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: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 4
Clinical phase
Not yet recruiting
Recruitment status
20
Planned enrollment
2027-07-01
Primary-completion proxy
Executive view
NCT07677566 evaluates Darolutamide in Localized Prostate Carcinoma. The disclosed sponsor is Nanjing Drum Tower Hospital, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is pCR + MRD, assessed over Screening, End of Neoadjuvant Treatment( 12 weeks after baseline).
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 NCT07677566 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Localized Prostate Carcinoma landscape. Drug & Asset MCP drug_fetch was queried for Darolutamide, while Company & Deal Intelligence MCP organization_fetch was queried for Nanjing Drum Tower Hospital.
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 |
|---|---|---|---|---|---|---|
| NCT07677566 | Darolutamide | Phase 4 / Not yet recruiting | Nanjing Drum Tower Hospital | China | pCR + MRD Screening, End of Neoadjuvant Treatment( 12 weeks after baseline) | 2027-07-01 |
| NCT07727473 | Semaglutide (Novo Nordisk) | Early Phase 1 / Not yet recruiting | Banner Health | United States | Change in Caspase-3 (CC3) activation between baseline biopsy and radical prostatectomy specimen Baseline (pre-treatment biopsy) through radical prostatectomy, assess… | 2028-05-01 |
| NCT07717099 | Radium Ra-223 Dichloride | Phase 2 / Not yet recruiting | Sponsor not reported | Spain | Treatment compliance Throughout the study treatment period, approximately 6 months | 2029-12-01 |
| NCT07683182 | Prilocaine Hydrochloride | Not Applicable / Active, not recruiting | Marmara University | Turkey | Pain During Transperineal Prostate Biopsy During the biopsy procedure | 2026-06-01 |
| NCT07674771 | Gallium GA-68 Gozetotide | Early Phase 1 / Not yet recruiting | The University of Texas Southwestern Medical Center | United States | Reduction in PSMA-positive TTV 1 YEAR | 2029-06-15 |
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.
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Protocol design and endpoint interpretation
NCT07677566 is a Phase 4, not yet recruiting study with 20 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “pCR + MRD” over “Screening, End of Neoadjuvant Treatment( 12 weeks after baseline).” The retrieved endpoint description is: pCR + MRD (pCR: Pathological Complete Response; Minimal Residual Disease (MRD) rate: defined as the proportion of patients achieving MRD among all patients; MRD is defined as postoperative pathology indicating that the longest diameter of the tumor is ≤ 5 mm).
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 20 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. 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 Localized Prostate Carcinoma. These records do not establish direct evidence for NCT07677566 unless the registration number matches.
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
Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy
Phase 4; n=10; Change in Cardiovagal Baroreflex Sensitivity(Mean) = 0.56 ms/mmHg (Standard Deviation, 1.48); Change in Cardiovagal Baroreflex Sensitivity(Mean) = -4.82 ms/mmHg (Standard Deviation, 1.84) Source: https://clinicaltrials.gov/ct2/show/results/NCT05700903
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
Darolutamide is indexed as Small molecule drug with AR biology and a global stage of Approved. The asset profile lists Orion Oyj as an originator or developer.
Nanjing Drum Tower Hospital is indexed in China with the website http://www.njglyy.com. Nanjing Drum Tower Hospital specializes in training and diganosis treatment. The record lists 25 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 Darolutamide 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: NCT07677566
Protocol source: https://clinicaltrials.gov/study/NCT07677566
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: 18 September 2026.
Darolutamide in Localized Prostate Carcinoma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes pCR + MRD and 2027-07-01 the leading decision points.
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