MR-guided prostate radiotherapy in seven days

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.