MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
About this study
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.
- Condition
- Prostate Cancer
- Tested
- MR-guided RT
- Sponsor
- Universitair Ziekenhuis Brussel
Who can join
- Age
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 12
- Minimum age: 18 years
- Eligible sex: Male
- Study condition: Prostate Cancer
- 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 11
- Transurethral resection (TUR) \< 3months before SBRT
- International Prostate Symptom Score (IPSS) \> 19
- Prostate volume \> 100cc on transrectal ultrasound (TRUS)
- Stage cT3b-T4
- N1 disease (clinically or pathologically)
- M1 disease (clinically or pathologically)
- PSA \> 40ng/mL
- inflammatory bowel disease
- immunosuppressive medications
- prior pelvic RT
- contra-indications for MRI
Where
1 site, 1 recruiting
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Brussels, Belgium
Contact
-
Mark De Ridder, MD
00324776041 mark.deridder@uzbrussel.be
-
Jacques Bezuidenhout, MD
Potential match only. Final eligibility is determined by the study team.