MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · May 17, 2021

Keywords

ClinConnect Summary

The Proseven trial is a research study looking at a new way to treat prostate cancer using a method called MR-guided stereotactic body radiotherapy (SBRT). This treatment is designed to deliver high doses of radiation to the cancerous area in the prostate over just 7 days, with patients receiving treatment five times during that week. The goal is to see how well this approach works and if it causes side effects, particularly related to the digestive and urinary systems, within three months after starting treatment.

To participate in the trial, patients need to be adult men aged 18 and older who have been diagnosed with certain types of prostate cancer that are considered low to limited high risk. They should have good overall health, as determined by a performance score, and must provide written consent to join the study. If eligible and enrolled, participants can expect a focused treatment schedule that aims to make the experience more convenient while still effectively targeting their cancer. It’s important to note that there are specific health conditions and prior treatments that would prevent someone from being eligible for this trial, so discussing personal medical history with a healthcare provider is essential.

Gender

MALE

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