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Antiandrogen

Talazoparib + Enzalutamide for Metastatic Prostate Cancer

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior treatment of mCSPC with docetaxel.
ECOG performance status 0 or 1.
Must not have
Clinically significant cardiovascular disease.
Any previous treatment with DNA-damaging cytotoxic chemotherapy within 5 years prior to randomization, except for indications other than prostate cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to 4 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new combination of drugs to treat men with aggressive prostate cancer that has spread and who have a specific genetic mutation.

Who is the study for?
Men 18+ (varies by country) with metastatic prostate cancer and confirmed DDR gene mutation. They must have adequate organ function, no prior docetaxel treatment for mCSPC, and agree to contraception use. Exclusions include previous treatments with certain drugs, active COVID-19 infection, history of seizures or major surgery within the last month.
What is being tested?
The trial is testing the effectiveness of talazoparib combined with enzalutamide versus a placebo plus enzalutamide in men with DDR-deficient metastatic prostate cancer. The goal is to see if talazoparib can improve outcomes when added to standard therapy.
What are the potential side effects?
Talazoparib may cause blood cell count issues, nausea, fatigue, hair loss; while enzalutamide might lead to hot flashes, hypertension or falls. Side effects vary per individual and should be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not been treated with docetaxel for my prostate cancer.
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I am fully active or can carry out light work.
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My prostate cancer is confirmed and does not have certain aggressive features.
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My prostate cancer has spread, confirmed by scans.
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I am able to understand and sign the consent form.
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My cancer has a DDR gene mutation confirmed by a specific test.
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I am currently on hormone therapy for cancer and have not had both testicles removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious heart condition.
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I haven't had chemotherapy that damages DNA for conditions other than prostate cancer in the last 5 years.
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I have brain metastasis or active leptomeningeal disease.
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I have not had major surgery in the last 4 weeks.
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I am experiencing symptoms related to spinal cord pressure.
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I have never been treated with PARPi and am not allergic to enzalutamide or talazoparib.
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I have a stomach or intestine problem that affects how my body absorbs food.
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I currently have COVID-19.
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I have taken more than 10 mg of prednisone or similar daily in the last 4 weeks.
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I have a history of seizures or conditions that could lead to seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
radiological Progression-Free Survival
Secondary study objectives
Duration of response in measurable soft tissue disease
Incidence of adverse events
Objective response in measurable soft tissue disease
+16 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment1 Intervention
Talazoparib plus enzalutamide
Group II: Arm 2Active Control1 Intervention
Placebo plus enzalutamide

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,660 Previous Clinical Trials
17,876,715 Total Patients Enrolled
42 Trials studying Prostate Cancer
12,240 Patients Enrolled for Prostate Cancer
Astellas Pharma IncIndustry Sponsor
695 Previous Clinical Trials
232,709 Total Patients Enrolled
35 Trials studying Prostate Cancer
8,043 Patients Enrolled for Prostate Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,545 Previous Clinical Trials
14,917,880 Total Patients Enrolled
8 Trials studying Prostate Cancer
3,319 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT04821622 — Phase 3
Prostate Cancer Research Study Groups: Arm 1, Arm 2
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT04821622 — Phase 3
Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04821622 — Phase 3
~104 spots leftby Sep 2025
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