Prostatectomy Adaptive Radiation Therapy (ART)

March 15, 2024 updated by: University Health Network, Toronto

A Feasibility Study of Post-operative Adaptive Radiation Therapy for Localized Prostate Cancer

This study will ultimately aim to evaluate the side effects of treatment by asking 20 subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan adapted after the first week of treatment to account for changes in the target shape. These patients will be asked to complete toxicity scores and a quality of life questionnaire at the start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of radiotherapy. These results will be used to determine the feasibility of the proposed approach, and obtain early estimates of improvements in uncertainty margin requirements for this population of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

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
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network, Princess Margaret Cancer 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:

  • Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy AND
  • Clinical stage pT3, pT4, or pT2 with positive margin OR
  • Any p-Stage with a persistently elevated post-operative PSA > 0.05 ng/ml OR
  • A delayed rise in PSA post-operatively

Exclusion Criteria:

  • Inflammatory bowel disease or other contraindications to radiotherapy
  • Prior pelvic radiotherapy
  • Previous cytotoxic chemotherapy
  • Radiological or pathologic evidence of nodal metastases.
  • Planned radiotherapy to pelvic lymph nodes
  • Evidence of systemic metastases on imaging.
  • Prosthetic hip replacement
  • No signed informed consent

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Post-Operative adaptive radiotherapy
All Patients enrolled in this study will have additional scans (Cone-Beam CT, MRI) daily during their treatment. This extra imaging will help us see any changes that might have occurred during radiation treatment and update the treatment plan to include these changes before patient treatment is continued.
Radiation: Post-operative Adaptive Radiation Therapy
Other Names:
  • All Patients enrolled in this study will have additional scans (Cone-Beam CT,MRI) daily during their treatment. This extra imaging will help us see any
  • changes that might have occurred during radiation treatment and update the treatment plan to include these changes before patient treatment is continued.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in radiation dose delivered to target volumes and normal tissue
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for radiotherapy replanning
Time Frame: 5 years
5 years
Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow.
Time Frame: 5 years
Feasibility will be assessed by the time required to perform the adaptive intervention
5 years
Toxicity associated with the adaptive radiotherapy technique.
Time Frame: 5 years
Assessments of gastrointestinal and genitourinary complications using the Common Toxicity Criteria for Adverse Events scoring system and the Expanded Prostate Cancer Index Composite questionnaire.
5 years

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Charles N Catton, MD, The Princess Margaret Cancer Foundation

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

July 1, 2013

Primary Completion (Actual)

May 16, 2023

Study Completion (Actual)

May 16, 2023

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimated)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 12-5318-C

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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