NCT06449781

177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer

177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High- and Very High-risk Prostate Cancer After Radical Treatment Using Locoregional Teleradiotherapy and Hormone Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy

Detailed description

The intervention will consist of a single administration of 177Lu-PSMA in the research arm. Both the study and control groups will receive standard hormone therapy. The study population includes 200 adult men with high-risk or very high-risk prostate cancer, with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy Participation time in the Study: intervention phase - 1 day; observation phase - 5 years

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Lutetium (177Lu) vipivotide tetraxetan	The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan

Timeline

• Start date: 2025-01-09
• Primary completion: 2030-11-01
• Completion: 2030-11-01
• First posted: 2024-06-10
• Last updated: 2025-02-10

Locations

1 site across 1 country: Poland