Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer

Improving Sexual Quality of Life - A Phase 2 Randomized Controlled Trial of Two Versus Five Stereotactic MRI-Guided Ablative Radiotherapy Treatments for Prostate Cancer

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Prostate Stereotactic ablative body radiotherapy (SABR) is an established technique that delivers radiation in a non-invasive approach for men with prostate cancer. The treatment regimen is given in total of 5 fractions with one treatment per day at every other day or weekly sessions. Ultra-hypofractionated radiotherapy (UHRT) is an emerging monotherapy for localized prostate cancer however, several trials have observed demonstrating superior biochemical control of a two-fraction (HDR) over single-fraction approach. The study aims to compare an experimental shorter course of prostate ultra-hypofractionated radiotherapy (UHRT) that will deliver what is expected to be an equivalent amount of radiation as given in the standard 5 treatment regimen. UHRT is given in 2 treatments with one treatment a week for 2 consecutive weeks.

Who May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-confirmed) prostate adenocarcinoma (centrally reviewed) 2. Low or favorable intermediate risk disease. Patient must meet one of the following categories: - Low risk - T1-T2b, grade group 1, AND PSA \< 10 ng/ml; - Favorable risk 1. Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng/ml; or 2. Grade group 3 AND PSA \< 20, AND \<cT2c AND absolute percentage pattern 4/5 is \<10% Who Should NOT Join This Trial: 1. Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned 2. Prior pelvic radiotherapy 3. Anticoagulation medication (if unsafe to discontinue for gold seed insertion) 4. Diagnosis of bleeding diathesis 5. Large prostate (\>90cm3) on imaging 6. Immunosuppressive medications 7. Inflammatory bowel disease 8. Presence of dual hip prostheses 9. Contraindications to having MRI Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Histologically confirmed prostate adenocarcinoma (centrally reviewed) 2. Low or favorable intermediate risk disease. Patient must meet one of the following categories: * Low risk - T1-T2b, grade group 1, AND PSA \< 10 ng/ml; * Favorable risk 1. Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng/ml; or 2. Grade group 3 AND PSA \< 20, AND \<cT2c AND absolute percentage pattern 4/5 is \<10% Exclusion Criteria: 1. Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned 2. Prior pelvic radiotherapy 3. Anticoagulation medication (if unsafe to discontinue for gold seed insertion) 4. Diagnosis of bleeding diathesis 5. Large prostate (\>90cm3) on imaging 6. Immunosuppressive medications 7. Inflammatory bowel disease 8. Presence of dual hip prostheses 9. Contraindications to having MRI

Treatments Being Tested

RADIATION

Stereotactic Ablative Body Radiation

2 Fraction

Locations (1)

Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada