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.
• 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