Trial · NCT06582628
Talazoparib Plus Enzalutamide After Progression to Prior ARPi in Metastatic Prostate Cancer
NCT06582628, Phase 2, Recruiting, Fundacion Oncosur
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Talazoparib Plus Enzalutamide After Progression to Prior ARPi in Metastatic Prostate Cancer. Trials, record NCT06582628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06582628
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Talazoparib Plus Enzalutamide After Progression to Prior ARPi in Metastatic Prostate Cancer
- NCT number
- NCT06582628
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 78 participants, estimated
- Lead sponsor
- Fundacion Oncosur
- Conditions
- Metastatic Prostate Cancer
- Interventions
- Enzalutamide capsule, Enzalutamide capsule and Talazoparib capsule
- First posted
- 2024-09-03
- Last updated
- 2026-10-05
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PSA response (PSA50) | within the first 16 weeks | Percentage of participants with a PSA decline greater than or equal to 50 percent from baseline confirmed by a consecutive PSA value (taken at least 3 weeks apart), prior to PSA progression |
| Primary | Objective response rate (ORR) | during the first 16 weeks | Defined as the best overall radiographic response (partial or complete) during the first 16 weeks on follow up as per investigator assessment of soft tissue/visceral disease per RECIST 1.1 in subjects who have a measurable tumour and/or Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases |
| Secondary | Radiographic Progression Free Survival (rPFS) | Through study completion, an average of 2 years | Time from randomization to first objective evidence of radiographic progression, based on RECIST 1.1 for soft tissue/visceral disease and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines for bone metastases, or death, whichever occurs first. |
| Secondary | Time to PSA Progression (TTPP) | Through study completion, an average of 2 years | Time from randomization to PSA progression defined as PSA greater than or equal to 25 percent and greater than or equal to 2ng/mL from nadir (or baseline for participants with no PSA decline), confirmed by a second value obtained 3 or more weeks apart as per PCWG3 guidelines. |
| Secondary | Time to unequivocal clinical progression (TTCP) | Through study completion, an average of 2 years | Time from randomization to clinical worsening of prostate cancer related symptoms, as new onset cancer pain requiring chronic administration of opiate analgesia, deterioration from prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher, time to first skeletal-related event (the time from randomization to first incidence of radiotherapy to the bone or bone surgery, pathological bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain); or initiation of subsequent lines of active treatment including cytotoxic chemotherapy or radiation therapy or surgical intervention due to complications or symptoms related to disease progression. |
| Secondary | Progression Free Survival (PFS) | Through study completion, an average of 2 years | Time from randomization to PSA progression, unequivocal clinical progression or radiographic progression, whichever occurs first. |
| Secondary | Incidence of adverse events (AEs) | Through study completion, an average of 2 years | Total, grouped by grades and AEs category, related and unrelated with the trial treatment. The AEs Defined as incidence of prespecified AEs as per National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, change from baseline in targeted vital signs and change from baseline in targeted clinical laboratory test results. |
| Secondary | Incidence of serious adverse events (SAEs) | Through study completion, an average of 2 years | Number of Serious Adverse Events, related and unrelated. SAEs leading to treatment discontinuation. |
| Secondary | Drug compliance | Through study completion, an average of 2 years | Percentage of dose taken for each treatment drug, dose reductions, dose discontinuation (temporary or permanent) |
| Other | Assessment of PSA response rate | Through study completion, an average of 2 years | In participants with and without germline and/or somatic DDR alterations. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes0
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/NCT06582628
GET https://conductscience.org/api/trials/v1/NCT06582628/registered?page=2