Trial · NCT06392841
Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
NCT06392841, Phase 2, Withdrawn, Qian Qin
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations. Trials, record NCT06392841. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06392841
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
- NCT number
- NCT06392841
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Qian Qin
- Conditions
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Deleterious HRR Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation, CHEK2 Gene Mutation, FANCA Gene Mutation, PALB2 Gene Mutation, RAD51B Gene Mutation, RAD54L Gene Mutation
- Interventions
- Androgen Deprivation Therapy (ADT), Niraparib/Abiraterone Acetate DAT, Abiraterone Acetate, Prednisone, Docetaxel
- First posted
- 2024-04-30
- Last updated
- 2026-04-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of participants with PSA decline to < 0.2 ng/ml | 24 weeks | PSA decline is defined as percentage of participants with PSA decline to \< 0.2 ng/ml at 24 weeks of therapy with ADT and niraparib/abiraterone acetate DAT plus prednisone as determined by Cycle 7 Day 1 PSA |
| Secondary | Rate of participants with PSA reduction ≥ 90% (PSA90) | 24 weeks | Percentage of participants with PSA reduction ≥ 90% (PSA90) after 24 weeks of therapy with ADT and niraparib/abiraterone acetate DAT plus prednisone as determined by Cycle 7 Day 1 PSA |
| Secondary | Percentage of participants with PSA decline to < 0.2 ng/ml (Cohort A) | 12 months | Percentage of participants with PSA decline to \< 0.2 ng/ml at one year in Cohort A |
| Secondary | Percentage of participants with PSA decline to < 0.2 ng/ml (Cohort B) | 12 months | Percentage of participants with PSA decline to \< 0.2 ng/ml at one year in Cohort B (with additional evaluation of ADT + docetaxel + abiraterone acetate plus prednisone versus ADT niraparib/abiraterone acetate DAT plus prednisone) |
| Secondary | Overall response rate (ORR) | 4 years | Defined as the proportion of subjects achieving either a complete response or a partial response by RECIST 1.1 in subjects with measurable disease and Prostate Cancer Working Group 3 (PCWG 3) criteria for subjects with bone only metastases (1, 2) |
| Secondary | PSA progression free survival (PFS) | 4 years | Defined as interval from start of study treatment to the earliest event of PSA progression or death due to any cause, or the date of last known follow-up without PSA progression, whichever occurs first, according to criteria of the PCWG 3 criteria: for subjects with a decline from baseline, PSA progression is defined as the time from start of therapy to first PSA increase that is ≥ 25% and ≥ 2 ng/mL above nadir which is confirmed by a second value 3 or more weeks later (2) |
| Secondary | Radiographic progression free survival (rPFS) | 4 years | Defined as duration from the start of study treatment to the date of first documentation of rPFS or death due to any cause, whichever occurs first, according RECIST 1.1 in subjects with measurable disease and PCWG3 criteria for subjects with bone only disease (1, 2) |
| Secondary | Safety of ADT and niraparib/abiraterone acetate DAT plus prednisone | 4 years | Safety of ADT + niraparib/abiraterone acetate DAT plus prednisone through evaluation of the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) as assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). |
| Secondary | Safety of ADT and docetaxel/abiraterone acetate plus prednisone | 4 years | Safety of ADT + docetaxel/abiraterone acetate plus prednisone through evaluation of the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) as assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). |
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/NCT06392841
GET https://conductscience.org/api/trials/v1/NCT06392841/registered