Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time (PATRIOT)

February 22, 2024 updated by: Dr. Aldrich Ong, CancerCare Manitoba

Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer

The purpose of this study is to compare the toxicity of two new radiation schedules for the treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered every other day over 11 days, or once per week over 29 days. Both of these schedules are shorter than the standard treatment which is usually 39 treatments over 8 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 0C2
        • BC Cancer Agency - Abbotsford Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Low or intermediate risk prostate cancer patients as defined by:

    • Clinical stage T1-2b, Gleason Score <=7, and PSA <=20 ng/mL
  • Age >= 18 years

Exclusion Criteria:

  • Androgen deprivation therapy (LHRH-agonists or antiandrogens) >6 months
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short treatment time (11 days)
Radiation: Image-guided radiotherapy
40 Gy / 5 fractions / 11 days
Radiation: Image-guided radiotherapy
40 Gy / 5 fractions / 29 days
Experimental: Long treatment time (29 days)
Radiation: Image-guided radiotherapy
40 Gy / 5 fractions / 11 days
Radiation: Image-guided radiotherapy
40 Gy / 5 fractions / 29 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bowel related quality-of-life
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal toxicity
Time Frame: During radiotherapy, at 3 and 6 months, then every 6 months after
Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
During radiotherapy, at 3 and 6 months, then every 6 months after
Genitourinary toxicity
Time Frame: During radiotherapy, at 3 and 6 months, then every 6 months after
Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
During radiotherapy, at 3 and 6 months, then every 6 months after
PSA relapse rate
Time Frame: 3 and 5 years
3 and 5 years
Patient Overall Quality of life
Time Frame: During radiotherapy, at 3 and 6 months, then every 6 months after
During radiotherapy, at 3 and 6 months, then every 6 months after
Salvage androgen deprivation therapy rate
Time Frame: 3 and 5 years
3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CancerCare Manitoba

Collaborators

Sunnybrook Health Sciences Centre
British Columbia Cancer Agency

Investigators

  • Principal Investigator: Aldrich Ong, MD, CancerCare Manitoba
  • Principal Investigator: Andrew Loblaw, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (Estimated)

August 26, 2011

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50-2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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