RecruitingNot ApplicableNCT05600400

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

Sponsor

Sunnybrook Health Sciences Centre

Enrollment

144 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Cancer of Prostate Prostate Adenocarcinoma

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria6

Histologically confirmed prostate adenocarcinoma (centrally reviewed)
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
Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng/ml; or
Grade group 3 AND PSA \< 20, AND \<cT2c AND absolute percentage pattern 4/5 is \<10%