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Antiandrogen

Talazoparib + Enzalutamide for Prostate Cancer (TALAPRO-2 Trial)

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

Surgically or medically castrated, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Must not have

Clinically significant cardiovascular disease

Patients whose only evidence of metastasis is adenopathy below the aortic bifurcation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 47 months

Awards & highlights

Pivotal Trial

Summary

This trial looks at whether adding the drug talazoparib to the drug enzalutamide improves progression-free survival in men with metastatic castration-resistant prostate cancer.

Who is the study for?

Men with advanced prostate cancer that's resistant to hormone therapy (mCRPC), not severely symptomatic, and have a life expectancy of at least 12 months. Participants must have rising PSA levels, be able to swallow pills, consent to genetic testing, and use effective contraception. Excluded are those who've had seizures, significant heart disease, recent opioid treatment for cancer pain or certain prior cancer treatments.

What is being tested?

The trial is examining if adding Talazoparib (a PARP inhibitor) to Enzalutamide (an anti-androgen drug) improves outcomes compared to using Enzalutamide alone in men with mCRPC. The study measures how long patients live without the disease getting worse.

What are the potential side effects?

Talazoparib may cause blood cell count changes leading to anemia or infection risk increase; fatigue; nausea; digestive issues; and rare but serious effects on the lungs or kidneys. Enzalutamide can cause fatigue, hot flashes, high blood pressure and rarely seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have undergone treatment to lower my testosterone levels below 50 ng/dL.

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I am fully active or can carry out light work.

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My prostate cancer is confirmed without specific aggressive features.

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I can swallow pills and have no allergies to medications I'm aware of.

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My cancer has worsened despite hormone therapy.

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My prostate cancer has spread, but I have little to no pain.

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My cancer has spread to my bones or soft tissues, confirmed by scans.

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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My cancer spread is limited to lymph nodes below where my aorta splits.

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I have taken opioids for prostate cancer pain within the last 28 days.

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I have serious kidney problems.

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I have severe liver problems.

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I have spinal cord compression or cauda equina syndrome.

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I have a digestive condition that affects how my body absorbs food.

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I cannot or will not use effective birth control methods.

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I have brain metastasis or active leptomeningeal disease.

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I have been treated with specific drugs for prostate cancer.

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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 ~ baseline up to 47 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 47 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 47 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2

Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1

Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1

+5 more

Secondary study objectives

Duration of soft tissue response (part 2) in unselected patients and in patients harboring DDR deficiencies

Incidence of adverse events (part 1 and 2)

Objective response in measurable soft tissue disease (part 2) in unselected patients and in patients harboring DDR deficiencies

+17 more