A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Danny Vesprini, M.D.
Danny.Vesprini@sunnybrook.ca
416-480-4806
Backup
Murtuza Saifuddin, M.S.
murtuza.saifuddin@sunnybrook.ca
416-480-5000
Time Frame
Start Date: 2023-12-11
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 20
Treatments
Experimental: Interventional
All radiotherapy will be delivered on the MR-linac
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov