Recruiting

SABR Treatments

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05600400

Conditions

Prostate Cancer

Cancer of Prostate

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Ablative Body Radiation

Study Details

Brief summary:

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

Prostate Cancer

Cancer of Prostate

Prostate Adenocarcinoma

Study ID

NCT05600400

Start date

Mar 1, 2024

Status verified date

Sep, 2025

Completion date

Jun, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Histologically confirmed prostate adenocarcinoma (centrally reviewed)
2. Low or favorable intermediate risk disease. Patient must meet one of the following categories:

  • Low risk - T1-T2b, grade group 1, AND PSA < 10 ng/ml;
  • Favorable risk

1. Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng/ml; or
2. Grade group 3 AND PSA < 20, AND <cT2c AND absolute percentage pattern 4/5 is <10%

Exclusion Criteria:

1. Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned
2. Prior pelvic radiotherapy
3. Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
4. Diagnosis of bleeding diathesis
5. Large prostate (>90cm3) on imaging
6. Immunosuppressive medications
7. Inflammatory bowel disease
8. Presence of dual hip prostheses
9. Contraindications to having MRI

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1

Two weekly fractions of 13.5 Gy

active comparator: Arm 2

Five every other day fractions of 8 Gy

Interventions

Stereotactic Ablative Body Radiation

2 Fraction

Primary outcome measure

  • Prostate Cancer Patient's Quality of Life Function will be measured to determine change in Quality of life function from baseline to 5 years beyond treatment. [ Time Frame: Change in patient Quaity of Life will be asseses from Before treatment (Baseline); week 1, 4 and 13; month 6 and every 6 months for 5 years ]

Central Contacts and Locations

Central contacts

Danny Vesprini, MD

416-480-6100Danny.Vesprini@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Daniel Vesprini, MD

4164804806danny.vesprini@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

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 2025-09-09.