Trial · NCT07490210
Rezvilutamide With Radical Prostatectomy and Metastasis-Directed Therapy in Oligometastatic Prostate Cancer
NCT07490210, Phase 2, Not yet recruiting, Fudan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rezvilutamide With Radical Prostatectomy and Metastasis-Directed Therapy in Oligometastatic Prostate Cancer. Trials, record NCT07490210. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07490210
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rezvilutamide With Radical Prostatectomy and Metastasis-Directed Therapy in Oligometastatic Prostate Cancer
- NCT number
- NCT07490210
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Fudan University
- Conditions
- Oligometastatic Prostate Cancer
- Interventions
- Metastasis-directed radiotherapy, Rezvilutamide + ADT, Radical prostatectomy
- First posted
- 2026-03-24
- Last updated
- 2026-03-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) | up to 72 months | Time from randomization to the first occurrence of biochemical progression, radiographic progression, clinical progression, or death. Biochemical progression: (1) For patients with PSA decline from baseline: PSA increase ≥25% and ≥1 ng/mL above nadir, confirmed by repeat testing ≥3 weeks later; or (2) For patients without PSA decline: PSA increase ≥25% and ≥1 ng/mL above baseline after ≥12 weeks of treatment. Radiographic progression: Disease progression per RECIST 1.1 (soft tissue) and PCWG4 (bone) criteria. Clinical progression: New symptoms due to local disease progression, lymph node involvement, or systemic metastases (e.g., pathologic fracture, spinal cord compression, worsening pain unresponsive to symptomatic treatment). |
| Secondary | Radiographic PFS (rPFS) | up to 72 months | Time from randomization to first radiographic disease progression (RECIST 1.1 for soft tissue; PCWG3 for bone) or death. |
| Secondary | Overall Survival (OS) | up to 72 months | Time from randomization to death from any cause. |
| Secondary | PSA Response Rates | up to 72 months | Proportion of patients achieving PSA50 (≥50% decline), PSA90 (≥90% decline), or undetectable PSA (\<0.2 ng/mL). |
| Secondary | Local Therapy Completion Rate | up to 72 months | Proportion of patients in experimental arms completing all planned local therapies (surgery ± radiotherapy). |
| Secondary | Time to CRPC | up to 72 months | Time from randomization to castration-resistant prostate cancer (disease progression per PSA or imaging criteria despite castrate testosterone levels \<50 ng/dL). |
| Secondary | 3-Year PSA Progression-Free Survival Rate | up to 72 months | Proportion of patients without PSA progression at 3 years. |
| Secondary | Time to PSA Progression | up to 72 months | Time from randomization to PSA progression (same criteria as biochemical progression in PFS). |
| Other | PSMA PET/CT-based rPFS (rPFS-PSMA). | up to 72 months | Time from randomization to the first documented radiographic disease progression as assessed by PSMA PET/CT (per PCWG4 criteria) or death from any cause. This endpoint evaluates the utility of molecular imaging compared to conventional imaging for detecting progression. |
| Other | Artificial Intelligence (AI) Predictive Model Development | up to 72 months | Development and validation of machine learning/deep learning models integrating multimodal data-including clinical-pathological variables (age, Gleason score, baseline PSA), imaging features (radiomics from PSMA PET/CT, CT/MRI), pathological features (surgical specimen characteristics), and molecular biomarkers-to predict patient prognosis (PFS, OS) and treatment response. This explores personalized risk stratification and treatment optimization through advanced data analytics. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07490210
GET https://conductscience.org/api/trials/v1/NCT07490210/registered