NCT06177093 Pilot Study of Dose Escalation in Prostate Radiotherapy Using the MR-Linac (DESTINATION-MRL)
| NCT ID | NCT06177093 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-12-11 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-12-11 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * Men aged ≥18 years * Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy * Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3) * MRI stage T2 or less (as staged by AJCC TNM 2018) * MRI-visible tumour(s) of PIRADS v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging (multiparametric MRI or mpMRI) with concordant pathology * Tumour nodule visible on MRI occupying \<50% of prostate on any axial slice and \<50% prostate volume * PSA \<20 ng/ml prior to starting ADT (if applicable) * Short course (\< 6 months) concurrent androgen deprivation therapy (antiandrogens or LHRH analogues) allowed though not mandated as per the discretion of the treating physician. * WHO Performance status 0-2 * Ability of the participant understand and the willingness to sign a written informed consent form. * Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study. 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.
Contact & Investigator
Danny Vesprini, M.D.
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT06177093 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06177093 currently recruiting?
Yes, NCT06177093 is actively recruiting participants. Contact the research team at Danny.Vesprini@sunnybrook.ca for enrollment information.
Where is the NCT06177093 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06177093 clinical trial?
NCT06177093 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Danny Vesprini, M.D. at Sunnybrook Health Sciences Centre. The trial plans to enroll 20 participants.
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