Comparing two versus five MRI-guided 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
This study is testing if giving radiation treatment for prostate cancer in just two sessions instead of five can work just as well for men with localized prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05600400 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of ultra-hypofractionated radiotherapy (UHRT) compared to the standard five-fraction stereotactic ablative body radiotherapy (SABR) for men with localized prostate cancer. The study aims to determine if delivering radiation in just two fractions over two weeks can achieve similar therapeutic outcomes as the traditional five-fraction regimen. Participants will receive highly conformal radiation treatment, which is less invasive and does not require general anesthesia. The trial is designed to assess both the efficacy and tolerability of the two approaches.
Who should consider this trial
Good fit: Ideal candidates for this study are men with histologically confirmed prostate adenocarcinoma who have low or favorable intermediate risk disease.
Not a fit: Patients who have undergone prior pelvic radiotherapy or are on anticoagulation medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more efficient and less invasive treatment option for men with prostate cancer, potentially improving their quality of life.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating that shorter treatment regimens can be effective for prostate cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Danny Vesprini, MD — Sunnybrook Health Sciences Centre
- Study coordinator: Danny Vesprini, MD
- Email: Danny.Vesprini@sunnybrook.ca
- Phone: 416-480-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.