Who is eligible for clinical trial NCT05600400?

Participants must meet protocol criteria for Prostate Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05600400 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-09-02

Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer (NCT05600400)

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Sunnybrook Health Sciences Centre

🩺 Plain-English Summary (8th-Grade Level)

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 can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (10 items).

Location: Sunnybrook Health Sciences Centre — Toronto, Ontario

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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%

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned
Prior pelvic radiotherapy
Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
Diagnosis of bleeding diathesis
Large prostate (\>90cm3) on imaging
Immunosuppressive medications
Inflammatory bowel disease
Presence of dual hip prostheses
Contraindications to having MRI

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Sunnybrook Health Sciences Centre — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗