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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.
Adequate organ function within 28 days before the first study treatment on Day 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to 4 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My organs are functioning well enough for treatment.
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I am willing and able to follow all study requirements.
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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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I am willing to give a sample of my tumor for further testing.
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My prostate cancer has spread, confirmed by scans.
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I am currently taking estrogens, cyproterone acetate, or first-generation anti-androgens.
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I am able to understand and sign the consent form.
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I have had radiation or surgery for symptom relief from prostate cancer.
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I am a man over the age of 18 (20 in Japan, 19 in Korea).
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My cancer has a DDR gene mutation confirmed by a specific test.
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I agree to give a saliva sample for genetic testing.
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I agree to use a condom and another effective birth control method if I'm sexually active.
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I have had ≤3 months of hormone therapy for my prostate cancer.
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I am currently on hormone therapy for cancer and have not had both testicles removed.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
radiological Progression-Free Survival
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,556 Previous Clinical Trials
10,907,083 Total Patients Enrolled
41 Trials studying Prostate Cancer
11,770 Patients Enrolled for Prostate Cancer
Astellas Pharma IncIndustry Sponsor
689 Previous Clinical Trials
219,440 Total Patients Enrolled
35 Trials studying Prostate Cancer
8,043 Patients Enrolled for Prostate Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,467 Previous Clinical Trials
8,088,520 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,819 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a significant number of hospitals participating in this clinical trial within the state?

"In addition to the Willis Knighton Advanced Urology in Shreveport, Louisiana, David C. Pratt Cancer Center in Saint Louis, Missouri, and CIUSSS- saguenay-Lac-Saint-Jean in Chicoutimi, Quebec; this study is also running out of 60 other locations."

Answered by AI

Are there precedent studies which have looked at talazoparib in combination with enzalutamide?

"The first study investigating talazoparib plus enzalutamide was completed in 2005 at Rosemere Cancer Centre. As of now, there have been 107 similar studies conducted with 160 more presently underway. A large portion of these active trials are based out Shreveport, Louisiana."

Answered by AI

Has the FDA sanctioned talazoparib in combination with enzalutamide?

"Talazoparib plus enzalutamide is considered safe by our team at Power. This is a Phase 3 trial, so there is some evidence of efficacy and the safety has been verified in multiple rounds of testing."

Answered by AI

How many people are included in this clinical trial?

"In order to properly conduct this trial, 550 eligible patients must be recruited. Patients can register for the trial at Willis Knighton Advanced Urology in Shreveport or David C. Pratt Cancer Center in Saint Louis."

Answered by AI

Are new participants being recruited for this experiment?

"Based on the information available on clinicaltrials.gov, it appears as though this study is still recruiting patients. The trial was established on May 12th, 2021 and updated October 26th, 2022. There are 60 sites enrolling a total of 550 participants."

Answered by AI
~196 spots leftby Sep 2025