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Prostatectomy Adaptive Radiation Therapy (ART)

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Post-operative Adaptive Radiation Therapy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Adaptive Radiotherapy, Prostatectomy, Patients who had a prostatectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Network, Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Post-Operative adaptive radiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in radiation dose delivered to target volumes and normal tissue

Secondary Outcome Measures

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

Full Information

First Posted
July 3, 2013
Last Updated
May 7, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02034955
Brief Title
Prostatectomy Adaptive Radiation Therapy (ART)
Official Title
A Feasibility Study of Post-operative Adaptive Radiation Therapy for Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Adaptive Radiotherapy, Prostatectomy, Patients who had a prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-Operative adaptive radiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Post-operative Adaptive Radiation Therapy
Other Intervention Name(s)
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.
Primary Outcome Measure Information:
Title
Change in radiation dose delivered to target volumes and normal tissue
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Time for radiotherapy replanning
Time Frame
5 years
Title
Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow.
Description
Feasibility will be assessed by the time required to perform the adaptive intervention
Time Frame
5 years
Title
Toxicity associated with the adaptive radiotherapy technique.
Description
Assessments of gastrointestinal and genitourinary complications using the Common Toxicity Criteria for Adverse Events scoring system and the Expanded Prostate Cancer Index Composite questionnaire.
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles N Catton, MD
Organizational Affiliation
The Princess Margaret Cancer Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Prostatectomy Adaptive Radiation Therapy (ART)

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