177Lu-PNT2002 PSMA in Metastatic Castrate Resistant Prostate Cancer
Research type
Research Study
Full title
SPLASH: Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using 177Lu-PNT2002 PSMA Therapy After Second-line Hormonal Treatment
IRAS ID
1004042
Contact name
Jessica Jensen
Contact email
Sponsor organisation
Point BioPharma Inc.
Eudract number
2021-002641-15
Clinicaltrials.gov Identifier
Research summary
This Phase 3 study aims to determine the safety and effectiveness of 177Lu PNT2002
compared to standard treatment, for patients with metastatic castration-resistant prostate
cancer (mCRPC) who have experienced disease progression following treatment with
abiraterone, enzalutamide, apalutamide or darolitamide.
177Lu PNT2002 is an investigational radioactive drug that targets a specific protein located
on the surface of prostate cancer cells, called prostate specific 177Lu-PNT2002 delivers
radiation to cancer cells by binding to the PSMA, which helps to destroy the cancer cells.
Participants will be randomised (assigned by chance) to either:
Arm A: participants will receive the study drug 177Lu-PNT2002 every 8 weeks for 4
treatment cycles or
Arm B: participants will receive the standard of care treatment, which will be either enzaluta
mide or abiraterone, orally every day.
There is 2 out of 3 chance to be assigned to Arm A and 1 out of 3 chance to be assigned to
Arm B. Participants in Arm B may be eligible to crossover to treatment with 177Lu-PNT2002
if their cancer progresses.
The study consists of a Screening period of up to 6 weeks, a 32week Treatment Period, and a
Long-term Follow-up (LTFU) Period for at least 5 years from the date of first treatment (or 5
years from the first dose of 177Lu-PNT2002for participants in Arm B and that crossover to
Arm A).
Participants assigned to Arm A may be requested to maintain an arm’s length distance from
others.
This is an open (the investigator and the patient will know what drugs are given) study and is
planned to run in 4 hospitals in the UK as well as hospitals in Europe and North America.REC name
London - Chelsea Research Ethics Committee
REC reference
21/LO/0693
Date of REC Opinion
24 Nov 2021
REC opinion
Further Information Favourable Opinion