Prostatectomy Adaptive Radiation Therapy (ART)

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: Post-operative Adaptive Radiation Therapy

• Registration Number: NCT02034955
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-14
• Primary Completion: 2023-05-16
• Study Completion: 2023-05-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post-Operative adaptive radiotherapy	Post-operative Adaptive Radiation Therapy	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 Measures

Name	Time	Method
Change in radiation dose delivered to target volumes and normal tissue	5 years

Secondary Outcome Measures

Name	Time	Method
Time for radiotherapy replanning	5 years
Toxicity associated with the adaptive radiotherapy technique.	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.
Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow.	5 years	Feasibility will be assessed by the time required to perform the adaptive intervention

Trial Locations

Locations (1)

University Health Network, Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada