NCT04896801Recruiting
MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Source: ClinicalTrials.gov · Last updated 4 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 13 May 2021
- Start date
- 10 Aug 2021
- Primary completion date
- Feb 2025
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Diseases
- Prostate cancer
- NCT number
- NCT04896801
What you commit to
- Study type: Interventional
- Planned participants: 132
- From 10 Aug 2021 to the primary completion date, Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Transurethral resection (TUR) \< 3months before SBRT
- immunosuppressive medications
- prior pelvic RT
Other illness
- N1 disease (clinically or pathologically)
- M1 disease (clinically or pathologically)
- inflammatory bowel disease
Other
- International Prostate Symptom Score (IPSS) \> 19
- Prostate volume \> 100cc on transrectal ultrasound (TRUS)
- Stage cT3b-T4
- PSA \> 40ng/mL
- contra-indications for MRI
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.