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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 (May 2026). This Phase 2 trial studies multiple treatments including Talazoparib with enzalutamide and Talazoparib for prostate cancer (adenocarcinoma).

Phase 2RecruitingProstate Cancer Clinical Trials ConsortiumNCT06844383Data as of May 2026

Treatment: Talazoparib with enzalutamide · TalazoparibThe 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.

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Extracted eligibility criteria

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)

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 →

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