Recruiting

SBRT

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06177093

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MR Linac delivered Radiotherapy

Study Details

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

Conditions

Prostate Cancer

Study ID

NCT06177093

Start date

Dec 11, 2023

Status verified date

May, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interventional

All radiotherapy will be delivered on the MR-linac

Interventions

MR Linac delivered Radiotherapy

All radiotherapy will be delivered on the MR-linac. The whole prostate will receive 30 Gy in 5 fractions and the dominant lesion plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.

Primary outcome measure

  • Technical Feasibility [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Danny Vesprini, M.D.

416-480-4806Danny.Vesprini@sunnybrook.ca

Murtuza Saifuddin, M.S.

416-480-5000murtuza.saifuddin@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Dr. Danny Vesprini, MD, FRCPC,

416-480-4806Danny.Vesprini@sunnybrook.ca

Murtuza Saifuddin, M.S.

4164805000murtuza.saifuddin@sunnybrook.ca

Principal Investigator:

Danny Vesprini, MD, FRCPC

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • Newly diagnosed intermediate risk localized prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-05-15.