Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: mCRPC

In brief

This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.

Key facts

Study ID

NCT03395197

Run by

Pfizer

People needed

1054

Starts

2017-12-18

Expected to finish

2027-06-30

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell features
• Asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mCRPC) (score on BPI-SF Question #3 must be < 4).
• For enrollment into Part 2 only (optional in Part 1): assessment of DDR mutation status
• Consent to a saliva sample collection for a germline comparator unless prohibited by local regulations or ethics committee decision (optional for patients in Part 1).
• Surgically or medically castrated, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening.
• Metastatic disease in bone documented on bone scan or in soft tissue documented on CT/MRI scan.
• Progressive disease at study entry in the setting of medical or surgical castration as defined by 1 or more of the following 3 criteria:
• Prostate specific antigen (PSA) progression defined by a minimum of 2 rising PSA values from 3 consecutive assessments with an interval of at least 7 days between assessments..
• Soft tissue disease progression as defined by RECIST 1.1.
• Bone disease progression defined by Prostate Cancer Working Group 3 (PCWG3) with 2 or more new metastatic bone lesions on a whole body radionuclide bone scan.
• Ongoing bisphosphonate or denosumab use prior to Day 1 (Part 1) or randomization (Part 2) is allowed but not mandatory.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
• Life expectancy ≥ 12 months as assessed by the investigator.
• Able to swallow the study drug and have no known intolerance to study drugs or excipients.
• Must agree to use a condom when having sex with a partner from the time of the first dose of study drug through 4 months after last dose of study treatment. Must also agree for female partner of childbearing potential to use an additional highly effective form of contraception from the time of the first dose of study treatment through 4 months after last dose of study treatment when having sex with a non pregnant female partner of childbearing potential.
• Must agree not to donate sperm from the first dose of study drug to 4 months after the last dose of study drug.
• Evidence of a personally signed and dated informed consent document (and molecular prescreening consent if appropriate) indicating that the patient [or a legally acceptable representative/legal guardian] has been informed of all pertinent aspects of the study.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

You may not qualify if…

• Any prior systemic cancer treatment initiated in in the non metastatic CRPC and mCRPC disease state.
• Patients whose only evidence of metastasis is adenopathy below the aortic bifurcation.
• Prior treatment with second-generation androgen receptor inhibitors (enzalutamide, apalutamide, and darolutamide), a PARP inhibitor, cyclophosphamide, or mitoxantrone for prostate cancer.
• Prior treatment with platinum-based chemotherapy within 6 months (from the last dose) prior to Day 1 (Part 1) or randomization (Part 2), or any history of disease progression on platinum-based therapy within 6 months (from the last dose).
• Treatment with cytotoxic chemotherapy, biologic therapy including sipuleucel T, or radionuclide therapy received in the castration-sensitive prostate cancer is NOT exclusionary if discontinued in the 28 days prior to Day 1 (Part 1) or randomization (Part 2).
• Treatment with any investigational agent within 4 weeks before Day 1 (Part 1) or randomization (Part 2).
• Prior treatment with opioids for pain related to either primary prostate cancer or metastasis within 28 days prior to Day 1 (Part 1) or randomization (Part 2).
• Current use of potent P-gp inhibitors within 7 days prior to Day 1 (Part 1) or randomization (Part 2).
• Major surgery (as defined by the investigator) within 2 weeks before Day 1 (Part 1) or randomization (Part 2), or palliative localized radiation therapy within 3 weeks before randomization (Part 2).
• Clinically significant cardiovascular disease
• Significant renal dysfunction as defined by any of the following laboratory abnormalities:
• Renal: eGFR < 30 mL/min/1.73 m2 by the MDRD equation (available via www.mdrd.com).
• Patients enrolled in Part 1 only: Moderate renal impairment (eGFR 30-59 mL/min/1.73 m2) at screening.
• Significant hepatic dysfunction as defined by any of the following laboratory abnormalities on screening labs:
• Total serum bilirubin >1.5 times the upper limit of normal (ULN) (>3 × ULN for patients with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation).
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times ULN (>5 × ULN if liver function abnormalities are due to hepatic metastasis).
• Albumin <2.8 g/dL
• Absolute neutrophil count < 1500/µL, platelets < 100,000/µL, or hemoglobin < 9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology values at screening).
• Known or suspected brain metastasis or active leptomeningeal disease.
• Symptomatic or impending spinal cord compression or cauda equina syndrome.
• Any history of myelodysplastic syndrome, acute myeloid leukemia, or prior malignancy except any of the following:
• Carcinoma in situ or non melanoma skin cancer
• Any prior malignancies ≥3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage.
• Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence or progression in the opinion of the investigator
• Gastrointestinal disorder affecting absorption.

Where it is running

• Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers — Chandler, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers — Gilbert, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers — Mesa, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers — Mesa, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers — Scottsdale, Arizona, United States
• Arizona Urology Specialists — Tucson, Arizona, United States
• Arizona Urology Specialists — Tucson, Arizona, United States
• Beverly Hills Cancer Center — Beverly Hills, California, United States
• South County Hematology/Oncology — Chula Vista, California, United States
• Sharp Rees-Stealy — Chula Vista, California, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• Marin Cancer Care, Inc. — Greenbrae, California, United States
• Cancer Center Oncology Medical Group — La Mesa, California, United States
• Loma Linda University Cancer Center - Records Management Only — Loma Linda, California, United States
• Loma Linda University Cancer Center - Hematology/Oncology Clinic — Loma Linda, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• UCLA Clark Urology Center — Los Angeles, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• Stanford Cancer Institute — Palo Alto, California, United States
• Desert Hematology Oncology Medical Group, Incorporation — Rancho Mirage, California, United States
• Eisenhower Medical Center — Rancho Mirage, California, United States
• Medical Oncology Associates-SD — San Diego, California, United States
• Sharp Memorial Hospital Investigational Pharmacy — San Diego, California, United States
• Alaska Urological Institute dba Alaska Clinical Research Center — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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