NCT07077239

Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity

MAgnetic Resonance Imaging or Computed Tomography Guided Stereotactic Body Radiotherapy With Online Adaptive Technology for Minimizing Toxicity During Salvage or AdjUvaNt Radiotherapy for ProstatE Cancer (MASAMUNE)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single-arm, prospective registry study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +/- pelvic lymph nodes. The decision to offer an adaptive treatment will be at the clinician's discretion.

Detailed description

This project is a single-arm, prospective study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +/- pelvic lymph nodes. There is no pre-specified target enrollment for patients undergoing standard non-adaptive SBRT. The target enrollment of patients undergoing adaptive treatment is 200 patients. The rate of accrual is expected to be in the range of 40 patients per year.

Conditions

• Prostate Cancer (CRPC)

Timeline

• Start date: 2025-07-17
• Primary completion: 2035-08-01
• Completion: 2036-08-01
• First posted: 2025-07-22
• Last updated: 2025-07-24

Locations

1 site across 1 country: United States