Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Comparing two radiation therapies for prostate cancer treatment

Official title: A Randomized Feasibility Trial of Stereotactic Body Radiotherapy Versus Conventional Fractionation With High Dose-rate (HDR) Brachytherapy Boost for Prostate Cancer

Run by Sunnybrook Health Sciences Centre · NCT04861415 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment55 (estimated)
SponsorSunnybrook Health Sciences Centre
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedDecember 23, 2020
Main results expectedJune 23, 2023
Study endsDecember 23, 2027
Registry record updatedApril 12, 2023
Trial IDNCT04861415 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with metastatic disease, serious medical comorbidities, or those who have undergone certain prior treatments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promising results with SBRT in various cancer types, suggesting potential for success in this novel application for prostate cancer.

Who can join: the full rules

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 it's running

  • Sunnybrook Health Sciences Centre
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.