De-escalated radiation therapy for localized prostate cancer

Is this trial a fit for you?

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

What this trial studies

This trial focuses on men with intermediate risk localized prostate cancer, aiming to develop a protocol for delivering a de-escalated dose of stereotactic body radiation therapy (SBRT) using an MR-linac. Participants will receive targeted radiation based on MRI assessments to minimize side effects while effectively treating the cancer. The study will evaluate acute and late toxicity levels, sexual quality of life, and biochemical relapse-free survival over a two-year period. The goal is to determine the feasibility of this tailored approach to improve patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Danny Vesprini, M.D. — Sunnybrook Health Sciences Centre
• Study coordinator: Danny Vesprini, M.D.
• Email: Danny.Vesprini@sunnybrook.ca
• Phone: 416-480-4806

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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.