MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Recruiting · NCT04896801 · Interventional (participants receive a specific treatment) · Lead sponsor: Universitair Ziekenhuis Brussel
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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 it is running
1 location listed.
- Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel - Brussels, Belgium