Pilot Study of Dose Escalation in Prostate Radiotherapy Using the MR-Linac (DESTINATION-MRL) (NCT06177093)
๐ฉบ Plain-English Summary (8th-Grade Level)
This study is a single centre feasibility trial. The trial will recruit men with intermediate risk localised prostate cancer who will all receive targeted dose (escalated/de-escalated dose directed by MRI) 5 fraction SBRT to the prostate. Trial Objectives are: 1. Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects 2. Secondary * To assess levels of acute GU and GI toxicity (CTCAE) * To assess levels of late GU and GI toxicity (CTCAE) * To assess late sexual quality of life (expanded EPIC, IIEF-5) * To assess biochemical relapse-free survival at 2
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (11 items).
Location: Sunnybrook Health Sciences Centre โ Toronto, Ontario
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- IPSS 19 or higher
- High grade disease (GG3) occult to MRI-defined lesion
- Post-void residual \>100 mls, where known
- Prostate volume \>90cc
- Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
- Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
- Previous pelvic radiotherapy
- Patients needing \>6 months of ADT due to disease parameters as per the discretion of the treating physician
- Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- Sunnybrook Health Sciences Centre โ Toronto, Ontario
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.