Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT05600400

Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer

Led by Sunnybrook Health Sciences Centre · Updated on 2025-09-09

144

Participants Needed

1

Research Sites

274 weeks

Total Duration

On this page

Sponsors

S

Sunnybrook Health Sciences Centre

Lead Sponsor

P

Prostate Cure Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Prostate Stereotactic ablative body radiotherapy (SABR) is an established technique that delivers radiation in a non-invasive approach for men with prostate cancer. The treatment regimen is given in total of 5 fractions with one treatment per day at every other day or weekly sessions. Ultra-hypofractionated radiotherapy (UHRT) is an emerging monotherapy for localized prostate cancer however, several trials have observed demonstrating superior biochemical control of a two-fraction (HDR) over single-fraction approach. The study aims to compare an experimental shorter course of prostate ultra-hypofractionated radiotherapy (UHRT) that will deliver what is expected to be an equivalent amount of radiation as given in the standard 5 treatment regimen. UHRT is given in 2 treatments with one treatment a week for 2 consecutive weeks.

CONDITIONS

Official Title

Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed prostate adenocarcinoma (centrally reviewed)
  • Low or favorable intermediate risk disease meeting one of the following: low risk (T1-T2b, grade group 1, and PSA < 10 ng/ml) or favorable risk with either one intermediate risk factor (cT2c, grade group 2, or PSA 10-20 ng/ml) or grade group 3 with PSA < 20, less than cT2c, and less than 10% pattern 4/5
Not Eligible

You will not qualify if you...

  • Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned
  • Prior pelvic radiotherapy
  • Anticoagulation medication if unsafe to stop for gold seed insertion
  • Diagnosis of bleeding diathesis
  • Large prostate (>90cm3) on imaging
  • Use of immunosuppressive medications
  • Inflammatory bowel disease
  • Presence of dual hip prostheses
  • Contraindications to having MRI

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N3M5

Actively Recruiting

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Research Team

D

Danny Vesprini, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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