NCT05313815

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
46mo left

Started Jul 2022

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jul 2022Apr 2030

First Submitted

Initial submission to the registry

March 15, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

7.7 years

First QC Date

March 15, 2022

Last Update Submit

June 3, 2026

Conditions

Prostate Cancer

Keywords

prostate cancerhigh risk prostate cancerhigh-risk prostate cancernode positive prostate cancernod-positive prostate cancerhypofractionation

Outcome Measures

Primary Outcomes (1)

  • Acute Grade >2 Gastrointestinal Toxicity

    Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Baseline to 5-year follow-up

Secondary Outcomes (8)

  • Patient-reported quality-of-life assessed by EPIC-26

    Baseline to 5-year Follow-up

  • Measure the severity of lower urinary tract symptoms during the study

    Baseline to 5-year Follow-up

  • Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity

    Baseline to 5-year Follow-up

  • Measure of oncologic outcomes

    Baseline to 5-year Follow-up

  • Measure of oncologic outcomes

    Baseline to 5-year Follow-up

  • +3 more secondary outcomes

Study Arms (1)

Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy

EXPERIMENTAL

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

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

Interventions

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

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

Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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))

You may not qualify if:

  • Prior pelvic radiotherapy.
  • Contraindications to radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Rachel Glicksman, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2022

First Posted

April 6, 2022

Study Start

July 18, 2022

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Last Updated

June 5, 2026

Record last verified: 2026-06

Locations

CA(1)