NCT07795177 Rezvilutamide 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 NCT07795177 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: 1 September 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07795177 is a hot trial to watch
Hormone-dependent prostate cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07795177 is notable because it evaluates Rezvilutamide in a Phase 2 design sponsored by Anhui Medical 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 | NCT07795177 |
| Official title | A Prospective Study Based on Spatial Multi-omics to Predict the Efficacy of ADT Combined With Second-generation Novel Hormonal Agents in Metastatic Hormone-sensitive Prostate Cancer. |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Rezvilutamide |
| Sponsor | Anhui Medical University |
| Geography | China |
| Enrollment | 40 |
| Primary endpoint | Biochemical Progression-Free Survival (bPFS) |
| Endpoint time frame | From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (±1 month) for up to 24 months. |
| Primary completion / readout proxy | Not reported |
Protocol design and endpoint interpretation
This study plans to enroll patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) and conduct a prospective, single-center, observational study. By performing whole-exome sequencing (WES), Xenium spatial transcriptomics, and PhenoCycler-Fusion spatial single-cell proteomics (PCF analysis) on tumor tissue samples, we aim to comprehensively delineate the molecular landscape of patients with different spatial multi-omic profiles in the real-world setting. We will investigate the associations between these molecular features and differential treatment responses to various therapeutic regimens, and further construct predictive models of treatment response. Ultimately, this will enable precise evaluation of treatment outcomes across distinct molecular subtypes and provide evidence to support individualized precision diagnostics and therapeutics for patients with mHSPC.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 40 participants across 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.
- Biochemical Progression-Free Survival (bPFS) (From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (±1 month) for up to 24 months.) — Time from initiation of ADT plus ARPI therapy to biochemical progression or death from any cause, whichever occurs first. Biochemical progression is defined as a PSA rise to ≥0.2 ng/mL after having reached an undetectable level, confirmed by a second measurement at least 2 weeks apart. Participants without an event will be censored at the date of last follow-up.
- Overall Survival (OS) (From treatment initiation until death or last follow-up, assessed up to 24 months.) — Time from treatment initiation to death from any cause. Participants alive or lost to follow-up will be censored at the date last known alive.
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: Rezvilutamide 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: Anhui Medical University is resolved to a normalized organization record in Hefei, 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
NCT07795177 provides a focused lens on Hormone-dependent prostate cancer development. Its value will be determined by whether Rezvilutamide can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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