Information for Healthcare Professionals

SPLASH: Study evaluating metastatic castrate resistant Prostate cancer using 177LU-PNT2002 PSMA Therapy After Second line Hormonal treatment

NOW ENROLLING

A Multicenter Phase 3, Open-Label, Randomized Study

About 177Lu-PNT2002

177Lu-PNT2002 is a PSMA-targeted radioligand under investigation for the treatment of PSMA-avid metastatic castration-resistant prostate cancer (mCRPC).

Access the HCP Summary Brochure Find a trial site / Refer a patient

Primary Endpoint

Radiological progression-free survival (rPFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Enrollment

Enrollment Size

415 Patients

Study Design

Part 1: 25-patient safety and dosimetry lead-in.
Part 2: Randomization (2:1) phase (approximately 390 patients). Subjects will receive either 177Lu-PNT2002 (Arm A), or enzalutamide or abiraterone (Arm B).
Note: Patients in Arm B who experience radiographic progression per central review and meet protocol defined eligibility, may crossover to receive 177Lu-PNT2002.
Follow-Up: All patients will receive long-term follow-up for at least 5 years from the first therapeutic dose, death, or loss to follow up.

Key Inclusion Criteria*

*For complete inclusion and exclusion criteria, please visit clinicaltrials.gov and search for NCT04647526.

Documented progressive mCRPC
Previous treatment with only one ARAT (abiraterone, enzalutamide, darolutamide, or apalutamide)
PSMA PET scan positive as per central review
Ineligible or refuse chemotherapy
Adequate organ function per laboratory assessments
ECOG: 0-1
No use of opioids for cancer-related pain ≤30 days prior to consent

Visit ClinicalTrials.gov for Full Eligibility Criteria