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ACTIVE NOT RECRUITING Phase 3

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

NCT03395197 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Talazoparib with enzalutamide
  • DRUG Placebo with enzalutamide

Study Locations (20)

California

  • Beverly Hills Cancer Center — Beverly Hills
  • South County Hematology/Oncology — Chula Vista
  • Sharp Rees-Stealy — Chula Vista
  • Glendale Adventist Medical Center — Glendale
  • Marin Cancer Care, Inc. — Greenbrae
  • Cancer Center Oncology Medical Group — La Mesa
  • Loma Linda University Cancer Center - Records Management Only — Loma Linda
  • Loma Linda University Cancer Center - Hematology/Oncology Clinic — Loma Linda
  • Loma Linda University Medical Center — Loma Linda
  • VA Long Beach Healthcare System — Long Beach
  • UCLA Clark Urology Center — Los Angeles
  • University of California, Irvine Medical Center — Orange

Arizona

  • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers — Chandler
  • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers — Gilbert
  • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers — Mesa
  • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers — Mesa
  • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers — Scottsdale
  • Arizona Urology Specialists — Tucson
  • Arizona Urology Specialists — Tucson

Alaska

  • Alaska Urological Institute dba Alaska Clinical Research Center — Anchorage

Trial Details

FieldValue
Enrollment Target 1,054 participants
Start Date 2017-12-18
Est. Completion 2027-06-30
Phase Phase 3

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03395197

The ClinicalTrials.gov registry entry for NCT03395197 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,054 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with mCRPC appearing as the primary indexed condition, and to 2 interventions — of which Talazoparib with enzalutamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03395197 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Alaska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03395197 about?

NCT03395197 is a clinical study titled "Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC". 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.

What is the current status of trial NCT03395197?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,054 participants. The study started on 2017-12-18. Estimated completion is 2027-06-30.

What conditions does trial NCT03395197 study?

This clinical trial studies the following conditions: mCRPC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03395197?

The interventions under investigation include: Talazoparib with enzalutamide (DRUG), Placebo with enzalutamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03395197?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03395197 being conducted?

This trial has 20 study locations across Alaska, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial