177Lu rhPSMA-10.1

Participants will receive 177Lu rhPSMA-10.1 alone.

Participants will receive 177Lu rhPSMA-10.1 alone. Participants will receive 177Lu rhPSMA-10.1 with Degarelix

Primary Objectives: The primary objective of the study is to assess safety and toxicity of 177Lu rhPSMA-10.1 Injection and to assess the impact of 177Lu rhPSMA-10.1 Injection with and without ADT on radiation dose delivered to the tumor in high risk localized and locoregional prostate cancer prior to primary radical prostatectomy with lymph node dissection.

To learn if the proposed dose of 177Lu rhPSMA-10.1 is safe. Phase 2 will open if the Phase 1 dose is found to be safe. To learn about the safety and effects of 177Lu rhPSMA-10.1 alone and with androgen deprivation therapy (ADT) on patients with high-risk, localized prostate cancer before they have surgery to remove the disease.

Live record on ClinicalTrials.gov →

• Men ≥18 years of age
• Histologically documented prostatic adenocarcinoma with an NCCN risk group of high-risk or very high-risk. NCCN High Risk and Very High-Risk criteria shown below. (Network, N.C.C. (2021).
• Prostate Cancer (Version 02.2021).
• Has no very-high-risk features and has exactly one high-risk feature:
• Grade Group 4 or Grade Group 5
• Has at least one of the following:

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.