NCT04896801 MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
| NCT ID | NCT04896801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2021-08-10 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 132 participants in total. It began in 2021-08-10 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Mark De Ridder, MD
PRINCIPAL INVESTIGATOR
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Frequently Asked Questions
Who can join the NCT04896801 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04896801 currently recruiting?
Yes, NCT04896801 is actively recruiting participants. Contact the research team at mark.deridder@uzbrussel.be for enrollment information.
Where is the NCT04896801 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT04896801 clinical trial?
NCT04896801 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Mark De Ridder, MD at Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel. The trial plans to enroll 132 participants.
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