Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer
Recruiting · NCT05600400 · Interventional (participants receive a specific treatment) · Lead sponsor: Sunnybrook Health Sciences Centre
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Inclusion criteria
- 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%
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
Where it is running
1 location listed.
- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada