NCT05600400Recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 12 Oct 2022
- Start date
- 1 Mar 2024
- Primary completion date
- Jan 2029
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Prostate cancer
- NCT number
- NCT05600400
What you commit to
- Study type: Interventional
- Planned participants: 144
- From 1 Mar 2024 to the primary completion date, Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned
- Prior pelvic radiotherapy
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- Immunosuppressive medications
Other illness
- Diagnosis of bleeding diathesis
- Inflammatory bowel disease
Other
- Large prostate (\>90cm3) on imaging
- Presence of dual hip prostheses
- Contraindications to having MRI
Who the study is looking for
- 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%
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.