OncoMatch/Clinical Trials/NCT06844383
A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate
Is NCT06844383 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Talazoparib with enzalutamide and Talazoparib for prostate cancer (adenocarcinoma).
Treatment: Talazoparib with enzalutamide · Talazoparib — The purpose of this study is to find out whether talazoparib in combination with enzalutamide or talazoparib alone delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have homologous recombination repair (HRR) mutations and have previously received abiraterone acetate.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Cancer type
Prostate Cancer
Biomarker criteria
Required: ATM pathogenic mutation
Required: ATR pathogenic mutation
Required: BRCA1 pathogenic mutation
Required: BRCA2 pathogenic mutation
Required: CDK12 pathogenic mutation
Required: CHEK2 pathogenic mutation
Required: FANCA pathogenic mutation
Required: MLH1 pathogenic mutation
Required: MRE11A pathogenic mutation
Required: NBN pathogenic mutation
Required: PALB2 pathogenic mutation
Required: RAD51C pathogenic mutation
Disease stage
Required: Stage IV
Metastatic disease required
Metastatic castration-resistant prostate cancer (mCRPC) as demonstrated by one of the following: Metastatic disease documented by conventional imaging...Measurable disease is not required.
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: abiraterone acetate with prednisone (abiraterone acetate, prednisone) — mHSPC or locally advanced disease
Received prior abiraterone acetate with prednisone for mHSPC or locally advanced disease and on which progressed via a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination or radiographic progression by any form of imaging
Cannot have received: androgen receptor pathway inhibitor (ARPI) other than abiraterone acetate with prednisone
Prior treatment for metastatic or non-metastatic CRPC with an ARPI other than abiraterone acetate with prednisone for ≥ 12 weeks
Cannot have received: PARP inhibitor
Prior treatment with a PARP inhibitor
Cannot have received: platinum-based chemotherapy
Prior platinum-based chemotherapy for the treatment of prostate cancer
Cannot have received: chemotherapy for castration-sensitive prostate cancer
Exception: chemotherapy completed >6 months prior to start of study treatment is allowed
Participants who received chemotherapy for castration-sensitive prostate cancer are still eligible provided chemotherapy was completed >6 months prior to start of study treatment
Cannot have received: investigational agents for the treatment of prostate cancer
Use of investigational agents for the treatment of prostate cancer within 4 weeks of start of study treatment
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/µl; Hemoglobin ≥ 9g/dl; Platelet count ≥ 100,000/µl
Kidney function
Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN); Potassium ≥ 3.5 mmol/L (within institutional normal range)
Liver function
Bilirubin ≤ 1.3 x ULN (unless documented Gilbert's disease); AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN
Normal organ function with acceptable initial laboratory values within 14 days of treatment start: Absolute neutrophil count ≥ 1,500/µl; Hemoglobin ≥ 9g/dl; Platelet count ≥ 100,000/µl; Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN); Potassium ≥ 3.5 mmol/L (within institutional normal range); Bilirubin ≤ 1.3 x ULN (unless documented Gilbert's disease); AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana Farber Cancer Institute · Boston, Massachusetts
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06844383 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior androgen receptor pathway inhibitor (ARPI) other than abiraterone acetate with prednisone, PARP inhibitor, platinum-based chemotherapy disqualifies patients from enrollment.
Does this trial require ATM?
Yes, ATM pathogenic mutation is a required biomarker for enrollment.
Does this trial require ATR?
Yes, ATR pathogenic mutation is a required biomarker for enrollment.
Does this trial require BRCA1?
Yes, BRCA1 pathogenic mutation is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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