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

Metastatic Castration-Resistant Prostate Cancer Clinical Trial

Official title:
A Phase 3, Open-Label, Randomized Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH)

Clinical Trial 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).

Clinical Trial Description

The primary objective of the study is to determine the efficacy of [Lu-177]-PNT2002 ([Lu-177]-PSMA-I&T) versus abiraterone or enzalutamide in delaying radiographic progression in patients with mCRPC. The study consists of 3 phases: Dosimetry, Randomized Treatment, and Long term Follow up. The study will commence with a 25-patient safety and dosimetry lead-in (Part 1) and proceed to a randomization treatment phase in approximately 390 patients (Part 2). Patients in Part 2 will be randomized in a 2:1 ratio to receive either [Lu-177]-PNT2002 (Arm A), or enzalutamide or abiraterone (Arm B). Patients in Arm B who experience radiographic progression per central review and meet protocol defined eligibility, may crossover to receive [Lu-177]-PNT2002. All patients will be followed in long-term follow-up for at least 5 years from the first therapeutic dose, death, or loss to follow up (Part 3). Only patients that meet PSMA PET avidity criteria per central review will be eligible for this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04647526
Study type Interventional
Source POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Contact
Status Active, not recruiting
Phase Phase 3
Start date February 25, 2021
Completion date March 2028
View Details
See also
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