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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).

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

Patient Sequencing

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
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SPLASH Trial Design

SPLASH Trial Design