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

NCT04647526 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2026-01-13

Study results available
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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).

Conditions

Interventions

DRUG

[Lu-177]-PNT2002

Participants randomized to Arm A will receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 every 8 weeks for 4 cycles

DRUG

Abiraterone

Abiraterone (1000 mg orally once daily with: 5 mg twice daily prednisone or 0.5 mg once daily dexamethasone)

DRUG

Enzalutamide

Enzalutamide (160 mg orally once daily)

Sponsors & Collaborators

  • POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company

    lead INDUSTRY

Principal Investigators

  • Jessica Jensen · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2023-11-01
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04647526 on ClinicalTrials.gov