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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 (Part 3).
Inclusion Criteria:
1. Male aged 18 years or older.
2. Confirmed diagnosis of prostate cancer.
3. Ineligible or averse to chemotherapeutic treatment options.
4. Patients must have progressive metastatic castration-resistant prostate cancer (mCRPC)
Exclusion Criteria:
1. Prior treatment for prostate cancer less than 28 days prior to randomization, with the exclusion of first-line local external beam, ARAT, luteinizing hormone-releasing hormone (LHRH) therapy, or non-radioactive bone-targeted agents.
2. Any prior cytotoxic chemotherapy for CRPC (e.g., cabazitaxel or docetaxel); chemotherapy for hormone-sensitive prostate cancer (HSPC) is allowed if the last dose was administered more than 1 year prior to consent.
Upper East Side - Manhattan
Open to Enrollment
