MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Universitair Ziekenhuis Brussel
132 participants
Aug 10, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 Criteria11
- 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
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04896801