CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 455 enrolled
Drug / intervention
[Lu-177]-PNT2002 +2 moredrug
Likely dose
Abiraterone 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04647526
NCT04647526Phase 3Active
CompareCT.gov

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)

POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company·interventional·Posted Dec 1, 2020·Updated Jan 13, 2026

In Brief

A Phase 3 clinical trial evaluating [Lu-177]-PNT2002, Abiraterone, and 1 other intervention for Metastatic Castration-Resistant Prostate Cancer. Active but no longer recruiting, targeting 455 participants across 54 sites in 6 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castration-Resistant Prostate Cancer
CountriesCanada, France, Netherlands, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
20212022202320242025202620272028
First PostedDec 1, 2020
Enrollment StartFeb 25, 2021
Primary CompletionNov 1, 2023
Study CompletionMar 1, 2028
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.6 years ago

Interventions

[Lu-177]-PNT2002drug

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

Abirateronedrug

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

Enzalutamidedrug

Enzalutamide (160 mg orally once daily)