NCT05600400 Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer
| NCT ID | NCT05600400 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2024-03-01 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Danny Vesprini, MD
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT05600400 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05600400 currently recruiting?
Yes, NCT05600400 is actively recruiting participants. Contact the research team at Danny.Vesprini@sunnybrook.ca for enrollment information.
Where is the NCT05600400 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05600400 clinical trial?
NCT05600400 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Danny Vesprini, MD at Sunnybrook Health Sciences Centre. The trial plans to enroll 144 participants.
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