Recruiting

Hypofractionated Boost

Sponsor:

University Health Network, Toronto

Code:

NCT05313815

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)

Study Details

Brief summary:

This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care.

Conditions

Prostate Cancer

Study ID

NCT05313815

Start date

Jul 18, 2022

Status verified date

Jun, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age > 18 years.
  • Able to provide informed consent.
  • Histologic diagnosis of prostate adenocarcinoma.
  • ECOG performance status 0-1.
  • High-risk localized disease by NCCN criteria (>cT3, Grade group >4, or PSA >20 ng/mL) or clinical N1 disease.
  • Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET))

Exclusion Criteria:

  • Prior pelvic radiotherapy.
  • Contraindications to radiotherapy

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy

External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes

Interventions

Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)

External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes

Primary outcome measure

  • Acute Grade >2 Gastrointestinal Toxicity [ Time Frame: Baseline to 5-year follow-up ]

Central Contacts and Locations

Central contacts

Rachel Glicksman, MD

416-946-4486rachel.glicksman@rmp.uhn.ca

Locations

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Rachel Glicksman, MD

416-946-4483rachel.glicksman@rmp.uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • prostate cancer
  • high risk prostate cancer
  • high-risk prostate cancer
  • node positive prostate cancer
  • nod-positive prostate cancer
  • hypofractionation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-05.