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ACTIVE NOT RECRUITING Phase 3

Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment

NCT04647526 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the efficacy and safety of \[Lu-177\]-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT).

Interventions

  • DRUG Enzalutamide
  • DRUG Abiraterone
  • DRUG [Lu-177]-PNT2002

Study Locations (20)

California

  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles
  • VA Greater Los Angeles Healthcare System — Los Angeles
  • University of California Los Angeles, Nuclear Medicine Clinic — Los Angeles
  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • UC Irvine Chao Family Comprehensive Cancer Center — Orange
  • Stanford Cancer Institute — Palo Alto

Missouri

  • VA St. Louis Health Care System — St Louis
  • Saint Louis University Hospital — St Louis
  • Washington University School of Medicine — St Louis

Maryland

  • University of Maryland Greenebaum Cancer Center — Baltimore
  • Chesapeake Urology Associates (CUA) P.A. — Towson

Michigan

  • University of Michigan Hospitals — Ann Arbor
  • Karmanos Cancer Center — Detroit

Arizona

  • Arizona Institute of Urology (AIU) - Tucson — Tucson

Colorado

  • University of Colorado Hospital — Aurora

Florida

  • H. Lee Moffitt Cancer Center & Research Institute — Tampa

Iowa

  • University of Iowa Hospitals and Clinics — Iowa City

Trial Details

FieldValue
Enrollment Target 455 participants
Start Date 2021-02-25
Est. Completion 2028-03
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04647526

The ClinicalTrials.gov registry entry for NCT04647526 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 455 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company, which has 1 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 Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 3 interventions — of which 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: NCT04647526 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Missouri, Maryland. 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 NCT04647526 about?

NCT04647526 is a clinical study titled "Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment". The purpose of this study is to evaluate the efficacy and safety of \[Lu-177\]-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT).

What is the current status of trial NCT04647526?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2021-02-25. Estimated completion is 2028-03.

What conditions does trial NCT04647526 study?

This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04647526?

The interventions under investigation include: Enzalutamide (DRUG), Abiraterone (DRUG), [Lu-177]-PNT2002 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04647526?

This trial is sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04647526 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Iowa. 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