NCT04896801

MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Proseven trial is a prospective interventional study that will evaluate the toxicity and efficacy of MR-guided stereotactic body radiotherapy (SBRT) in the profound hypofractionated treatment of prostate cancer. Patients will be treated in 5 daily fractions within a short overall treatment time (OTT) of 7 days. A simultaneous integrated boost (SIB) will be delivered to the intraprostatic dominant lesion (if present) in this study. Besides a potential biological impact of this innovative prostate SBRT treatment, the reduced OTT offers also benefits in terms of patient convenience. The primary endpoint is clinician reported grade 2 or more acute gastrointestinal (GI) and genitourinary (GU) toxicity, assessed using CTCAE v 5.0 and RTOG, measured up to 3 months after the first treatment fraction.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	MR-guided RT	The dose to the planning target volume (PTV) is 36 Gy (5 x 7.2 Gy) prescribed on the 90% isodose line. The clinical target volume (CTV) is receiving 40 Gy (5 x 8 Gy = 100%). A simultaneous integrated boost (SIB) up to a total dose of 42 Gy (5 x 8.4 Gy = 105%) is delivered to the gross tumor volume (GTV), if present. In addition, relative sparing of the urethra will be applied by avoiding hotspots (V40 Gy \< 1cc) in the urethra. Baseline and adapted treatment plans are generated using intensity-modulated RT

Timeline

• Start date: 2021-08-10
• Primary completion: 2025-02-01
• Completion: 2030-02-01
• First posted: 2021-05-21
• Last updated: 2024-12-04

Locations

1 site across 1 country: Belgium