Comparing two radiation therapies for prostate cancer treatment
A Randomized Feasibility Trial of Stereotactic Body Radiotherapy Versus Conventional Fractionation With High Dose-rate (HDR) Brachytherapy Boost for Prostate Cancer
This study is testing whether a newer type of radiation therapy called SBRT is better than traditional radiation treatments for men with prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04861415 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of stereotactic body radiation therapy (SBRT) compared to conventional fractionated radiation following high-dose rate (HDR) brachytherapy for prostate cancer. Participants will be randomly assigned to receive either five treatments of SBRT or a traditional radiation schedule that spans three to five weeks. The goal is to determine the feasibility and potential benefits of SBRT as a treatment option in this context, particularly in light of recent advancements in radiation delivery. The study aims to provide insights into patient outcomes and treatment efficiency.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 or older with a confirmed diagnosis of prostate adenocarcinoma and an ECOG performance status of 0-2.
Not a fit: Patients with metastatic disease, serious medical comorbidities, or those who have undergone certain prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more efficient and effective treatment option for prostate cancer patients, potentially reducing treatment time and improving outcomes.
How similar studies have performed: Other studies have shown promising results with SBRT in various cancer types, suggesting potential for success in this novel application for prostate cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Informed consent for treatment and study participation completed * Pathologically proven diagnosis of prostate adenocarcinoma * ECOG Performance Status 0-2 * No prior history of pelvic radiotherapy, brachytherapy, cryosurgery, HIFU, TURP or radical prostatectomy Exclusion Criteria: * Presence of nodal or distant metastasis on staging MRI or CT Abdomen/Pelvis and Bone scan within 90 days of enrolment (CT/MRI/Bone Scan are only required if the clinical risk of metastatic disease is sufficient to warrant these scans) * Plan for adjuvant chemotherapy post-radiotherapy * Serious medical comorbidities or other contraindications to HDR brachytherapy * Presence of inflammatory bowel disease * Presence of connective tissue disorder seen as a contraindication to radiotherapy * Medically unfit for general/spinal anesthesia * Unable or unwilling to complete questionnaires
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Gerard Morton — Sunnybrook Health Sciences Centre
- Study coordinator: Gerard Morton, MD
- Email: gerard.morton@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.