Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH)
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- STATUS
- Recruiting
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- End date
- Mar 16, 2028
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- participants needed
- 415
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- sponsor
- POINT Biopharma
Jessica Jensen
Primary Contact
Princess Margaret Cancer Centre (0.5 mi away) Contact
+47 other locationSummary
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).
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.
Details
| Condition | Metastatic Castration-Resistant Prostate Cancer |
|---|---|
| Treatment | Abiraterone, Enzalutamide, [Lu-177]-PNT2002 |
| Clinical Study Identifier | NCT04647526 |
| Sponsor | POINT Biopharma |
| Last Modified on | 16 June 2022 |
Eligibility
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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