MR-guided prostate radiotherapy in seven days
Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
This study is testing a new way to deliver prostate cancer radiation treatment in just seven days to see if it works well and causes fewer side effects for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT04896801 on ClinicalTrials.gov |
What this trial studies
The Proseven trial is a prospective interventional study aimed at evaluating the toxicity and efficacy of MR-guided stereotactic body radiotherapy (SBRT) for prostate cancer. Patients will receive treatment in five daily fractions over a condensed treatment period of seven days, with a simultaneous integrated boost delivered to any dominant lesions. The study focuses on assessing acute gastrointestinal and genitourinary toxicity using established clinical criteria, measured up to three months post-treatment. This innovative approach not only aims to improve treatment outcomes but also enhances patient convenience through a shorter overall treatment time.
Who should consider this trial
Good fit: Ideal candidates include adult males over 18 with histologically confirmed prostate adenocarcinoma, ranging from low to limited high-risk classifications.
Not a fit: Patients with advanced prostate cancer stages, significant comorbidities, or those who have undergone recent prostate procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and convenient option for patients with prostate cancer.
How similar studies have performed: Other studies have shown promise with similar MR-guided radiotherapy approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels
- Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Mark De Ridder, MD — Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
- Study coordinator: Mark De Ridder, MD
- Email: mark.deridder@uzbrussel.be
- Phone: 00324776041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.