NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial
M.D. Anderson Cancer Center
Summary
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.
Description
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. Secondary Objectives: * To assess the impact on pathologic outcomes at radical prostatectomy after 2 cycles of 177Lu rhPSMA-10.1 Injection with and without ADT Exploratory Objectives * To evaluate the IHC expression of PSMA on pre-treatm…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Men ≥18 years of age 2. 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). High Risk: * Has no very-high-risk features and has exactly one high-risk feature: * cT3a * Grade Group 4 or Grade Group 5 * PSA \>20 ng/mL Very high: * Has at least one of the following: * cT3b-cT4 * Primary Gleason pattern 5 * 2 or 3 high-risk features * \>4 cores with Grade Group 4 or 5…
Interventions
- DrugArm A: 177Lu rhPSMA-10.1
Participants will receive 177Lu rhPSMA-10.1 alone.
- DrugArm B: 177Lu rhPSMA-10.1 plus Degarelix
Participants will receive 177Lu rhPSMA-10.1 alone. Participants will receive 177Lu rhPSMA-10.1 with Degarelix
Location
- M D Anderson Cancer CenterHouston, Texas