NCT06066437

NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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-treatment prostate biopsy specimen compared to post ADT and 177Lu rhPSMA-10.1 Injectiontreatment surgical pathology * To assess the impact on PSMA PET signal after treatment with 177Lu rhPSMA-10.1 Injection with and without ADT * To evaluate efficacy of neoadjuvant 177Lu rhPSMA-10.1 Injection with or without ADT in men with high-risk and localized prostate cancer planned to undergo radical prostatectomy * To evaluate exploratory predictive biomarkers for 177Lu rhPSMA-10.1 Injection with or without ADT including circulating tumor cells and extracellular vesicles

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Arm A: 177Lu rhPSMA-10.1	Participants will receive 177Lu rhPSMA-10.1 alone.
DRUG	Arm B: 177Lu rhPSMA-10.1 plus Degarelix	Participants will receive 177Lu rhPSMA-10.1 alone. Participants will receive 177Lu rhPSMA-10.1 with Degarelix

Timeline

• Start date: 2024-03-29
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-10-04
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study