Status:
RECRUITING
MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 p...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
August 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04896801
Start Date
August 10 2021
End Date
February 1 2030
Last Update
December 4 2024
Active Locations (1)
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1
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Brussels, Belgium