Trial · NCT06134271
Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer
NCT06134271, Phase 2, Unknown, Jianbin Bi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer. Trials, record NCT06134271. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06134271
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer
- NCT number
- NCT06134271
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 160 participants, estimated
- Lead sponsor
- Jianbin Bi
- Conditions
- Metastatic Hormone-Sensitive Prostate Cancer
- Interventions
- Rezvilutamide, Rezvilutamide plus abiraterone, Continue previous treatment
- First posted
- 2023-11-18
- Last updated
- 2023-11-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to castration-resistant prostate cancer (CRPC) | From the first day of patient enrollment until the time reach CRPC, the duration of the assessment should not exceed 24 months. | The time reach CRPC is defined as the occurrence of the following events, whichever occurs first, serum PSA progression: PSA value\>2 ng/ml, interval of 1 week, consecutive 2 times, increase\>50% from baseline, serum testosterone at castrated level (\<50 ng/dL or 1.7 nmol/L) or soft tissue, visceral imaging progression or bone injury (following the recommendations of Prostate Cancer Clinical Trial Working Group 3 \[PCWG3\]); Imaging progression of soft tissue/visceral lesions based on magnetic resonance imaging (MRI)/computed tomography (CT) performed by researchers on the chest, abdomen, and pelvis (based on RECIST 1.1). |
| Secondary | Overall survival (OS) | From the first day of patient enrollment to all-cause mortality, the duration of the assessment should not exceed 24 months. | Overall survival is defined as the time from the first day of enrollment to the patient's death due to any cause. |
| Secondary | Radiographic Progression-free survival (rPFS) | From the first day of patient enrollment to the time reach radiographic progression, the duration of the assessment should not exceed 24 months. | The radiographic progression free survival is defined as the time from the first day of patient enrollment to imaging progression or death. Imaging progress includes progress under bone scanning, where at least 2 new lesions are discovered under bone scanning, or measurable soft tissue lesions are detected under computed tomography (CT) or magnetic resonance imaging (MRI) (based on the definition of the Solid Tumor Response Evaluation Standard (RECIST) version 1.1). According to RECIST 1.1 guidelines, progression requires a 20% increase in the sum of all target lesion diameters, and an absolute minimum sum increase of 5 millimeters (mm) compared to the sum of the lowest values. |
| Secondary | Time to first Symptomatic Skeletal Event (SSE) | From the first day of patient enrollment to the occurrence of the SSE, the duration of the assessment should not exceed 24 months. | Symptomatic Skeletal Event (SSE) is defined as the occurrence of the following events, including fractures, spinal cord compression, bone specific radiotherapy or surgery, and death from any cause, whichever occurs first.radiotherapy or surgery for bones, death for all cause, whichever occurs first. |
| Secondary | Liver function assessment | From the first day of patient enrollment to the end of treatment, the evaluation duration should not exceed 24 months | Liver function will be assessed once every 2 weeks in the first three cycles, once every 4 weeks in the continues treatment. |
| Secondary | Safety profile | From the first day of patient enrollment to the end of treatment, the evaluation duration should not exceed 24 months | Any adverse events were recorded starting from the first administration of riviramide or the combination of riviramide and abiolone until the end of the safety follow-up period.Among them, liver function assessment is conducted in the first 3 cycles, once every 2 weeks; Subsequent treatment should be conducted once every 4 weeks. |
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/NCT06134271
GET https://conductscience.org/api/trials/v1/NCT06134271/registered