MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Key facts
- Where
- Brussels, BelgiumSee the site
Where in Belgium
- Department of Radiotherapy, UZ Brussel, Vrije Universiteit BrusselBrussels, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitair Ziekenhuis Brussel
- Trial code
- NCT04896801
- Record updated
- 4 December 2024
- Original description
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.Read full original descriptionShow less
Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
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.
Inclusion: Age > 18 y; Histologically confirmed prostate adenocarcinoma; Low risk: cT1c-T2a, Gleason score 6, PSA < 10ng/mL; Favorable intermediate risk: 1 intermediate risk factor, Gleason 3+4 or less, < 50% positive biopsy cores); Unfavorable intermediate risk: > 1 intermediate risk factor, Gleason 4+3, > 50% positive biopsy cores); Limited high risk: cT3a with PSA < 40ng/mL or cT2a-c with a Gleason score > 7 and/or a PSA > 20ng/mL but < 40ng/mL; World Health Organization performance score 0-2; Written informed consent; Intermediate risk factors: T2b-T2c, Gleason 7, PSA 10-20 ng/mL.
Exclusion: Transurethral resection (TUR) < 3months before SBRT; immunosuppressive medications; prior pelvic RT; N1 disease (clinically or pathologically); M1 disease (clinically or pathologically); inflammatory bowel disease; International Prostate Symptom Score (IPSS) > 19; Prostate volume > 100cc on transrectal ultrasound (TRUS); Stage cT3b-T4; PSA > 40ng/mL; contra-indications for MRI.