Actively Recruiting
Improving Sexual Quality of Life - A Phase 2 Randomized Controlled Trial of Two Versus Five MRI-Guided Stereotactic Ablative Radiotherapy Treatments for Prostate Cancer
Led by Sunnybrook Health Sciences Centre · Updated on 2025-09-09
144
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
P
Prostate Cure Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a shorter course of ultra-hypofractionated radiotherapy (UHRT) for men with localized prostate cancer. This study compares a new two-treatment regimen to the standard five-treatment regimen, aiming to deliver an equivalent amount of radiation. UHRT is a promising approach that uses fewer but higher doses of radiation to target prostate cancer more effectively while potentially improving tolerability. The trial compares two groups: one receiving two weekly fractions of 13.5 Gy each, and the other receiving five every-other-day fractions of 8 Gy each. Treatments use stereotactic ablative body radiotherapy (SABR) guided by MRI, which is a non-invasive, highly precise radiation technique. The two-treatment regimen is expected to be easier to tolerate and less invasive than other methods like high dose rate brachytherapy. Participants will be monitored closely from before treatment through five years after treatment. Researchers will assess changes in quality of life, treatment toxicity, prostate-specific antigen (PSA) levels, biochemical control of cancer, and need for additional therapy. Evaluations occur at multiple timepoints including weeks 1, 4, and 13, month 6, and every 6 months up to 5 years. This long-term follow-up helps measure treatment effects and patient well-being over time.
CONDITIONS
Brief Title
Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate adenocarcinoma
- Low or favorable intermediate risk disease defined by specific clinical and PSA criteria
- Male patients aged 18 years or older
You will not qualify if you...
- Androgen deprivation therapy given or planned
- Prior pelvic radiotherapy
- Use of anticoagulation medication if unsafe to stop for gold seed insertion
- Diagnosis of bleeding diathesis
- Large prostate volume greater than 90 cm3 on imaging
- Use of immunosuppressive medications
- Inflammatory bowel disease
- Presence of dual hip prostheses
- Contraindications to having an MRI scan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 weeks depending on treatment arm
Participants receive either two weekly fractions or five every other day fractions of stereotactic ablative body radiation for prostate cancer.
2 visits for two-fraction arm or 5 visits for five-fraction arm (in-person)
Duration - Up to 5 years
Participants have periodic assessments to monitor quality of life, toxicity, and prostate cancer control after treatment.
Visits at week 1, 4, and 13; month 6; and every 6 months up to 5 years
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
Research Team
D
Danny Vesprini, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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