Prostatectomy Adaptive Radiation Therapy (ART)

N/ACompletedNCT02034955

University Health Network, Toronto21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Post-operative Adaptive Radiation TherapyRADIATION

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Change in radiation dose delivered to target volumes and normal tissue

Time frame: 5 years

Secondary Outcomes

Time for radiotherapy replanning

Time frame: 5 years

Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow.

Feasibility will be assessed by the time required to perform the adaptive intervention

Time frame: 5 years

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.

Time frame: 5 years

Data from ClinicalTrials.gov

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