Prostatectomy Adaptive Radiation Therapy (ART)

University Health Network, Toronto

Status: Completed

Conditions: Prostate Cancer

Treatments: Radiation: Post-operative Adaptive Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02034955

UHN REB 12-5318-C

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Post-Operative adaptive radiotherapy

Experimental group

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.

Treatment:

Radiation: Post-operative Adaptive Radiation Therapy