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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization up to 4 years

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

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

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,625 Previous Clinical Trials

14,283,595 Total Patients Enrolled

43 Trials studying Prostate Cancer

12,304 Patients Enrolled for Prostate Cancer

Astellas Pharma IncIndustry Sponsor

695 Previous Clinical Trials

232,722 Total Patients Enrolled

35 Trials studying Prostate Cancer

8,044 Patients Enrolled for Prostate Cancer

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,518 Previous Clinical Trials

11,458,171 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

~127 spots leftby Sep 2025

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