NCT07503379 Docetaxel Hormone-dependent prostate cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07503379 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 26 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07503379 is a hot trial to watch
Hormone-dependent prostate cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07503379 is notable because it evaluates Docetaxel in a Phase 2 design sponsored by Sun Yat-Sen University. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07503379 |
| Official title | Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC (LoDARO) |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Docetaxel |
| Sponsor | Sun Yat-Sen University |
| Geography | China |
| Enrollment | not reported |
| Primary endpoint | Undetectable PSA(<0.2ng/ml) at 24w |
| Endpoint time frame | 6 months |
| Primary completion / readout proxy | not reported |
Protocol design and endpoint interpretation
This is a single-arm, prospective, multicenter, interventional study, aimed at exploring the efficacy and safety of darolutamide + ADT combined with low-dose docetaxel in treating patients with mHSPC planning to recruit approximately 109 patients. The purpose of this study is to investigate the proportion of patients who reach PSA undetectable (PSA< 0.2ng/ml) at the primary analysis (24 weeks). According to the ARASENS study, the percentage of undetectable PSA in the experimental arm in the Chinese subset at 24 weeks is 46.2%. This study calculates that it is possible to maintain the therapeutic efficacy of PSA while reducing the dose of docetaxel.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment was not reported; study geography in China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Undetectable PSA(<0.2ng/ml) at 24w(6 months)
- Undetectable PSA(<0.2ng/ml) at 24w(6 months) — Defined as the ratio of the number of subjects whose PSA less than 0.2ng/ml to the total number of subjects whose PSA response can be evaluated within 24 weeks
Readout outlook and evidence gap
The current protocol points to not reported as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Docetaxel is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Sun Yat-Sen University is resolved to a normalized organization record in Guangzhou, China. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07503379 provides a focused lens on Hormone-dependent prostate cancer development. Its value will be determined by whether Docetaxel can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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