Prostatectomy Adaptive Radiation Therapy (ART)

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034955
• Other study ID #: UHN REB 12-5318-C
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: May 16, 2023

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Post-operative Adaptive Radiation Therapy

Locations

Country	Name	City	State
Canada	University Health Network, Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in radiation dose delivered to target volumes and normal tissue		5 years
Secondary	Time for radiotherapy replanning		5 years
Secondary	Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow.	Feasibility will be assessed by the time required to perform the adaptive intervention	5 years
Secondary	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.	5 years