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

NCT05600400 | Recruiting DMC

• 1 other identifier: iSMART
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Expanded Prostate Cancer Index Composite questionnaires will be scored and analyzed to determine change in Quality of life function from baseline

  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

Secondary Outcomes (6)

• Toxicity in patients

  Before treatment (Baseline); week 1, 4 and 13; month 6 and every 6 months for 5 years

• Proportion of patients with 4 year PSA value of <0.4 ng/ml

  Before treatment (Baseline); months 3 and 6; and every 6 months for 5 years

• Biochemical Control in Prostate Patients

  Before treatment (Baseline); months 3 and 6; and every 6 months for 5 years

• Salvage Therapy Rate

  5 years

• Health Utilities Outcome

  5 years

Study Arms (2)

Arm 1

EXPERIMENTAL

Two weekly fractions of 13.5 Gy

Radiation: Stereotactic Ablative Body Radiation

Arm 2

ACTIVE COMPARATOR

Five every other day fractions of 8 Gy

Radiation: Stereotactic Ablative Body Radiation

Interventions

Stereotactic Ablative Body Radiation RADIATION

2 Fraction

Also known as: SBRT

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed prostate adenocarcinoma (centrally reviewed)
• 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
• Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng/ml; or
• Grade group 3 AND PSA \< 20, AND \<cT2c AND absolute percentage pattern 4/5 is \<10%

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Prostate Cure Foundation: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Danny Vesprini, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danny Vesprini, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Model Details: 2 fraction SBRT

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 31, 2022
• Study Start: March 1, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)