Prostatectomy Adaptive Radiation Therapy (ART)

NCT02034955 | Completed

• 1 other identifier: UHN REB 12-5318-C
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Adaptive Radiotherapy; Prostatectomy; Patients who had a prostatectomy

Outcome Measures

Primary Outcomes (1)

• Change in radiation dose delivered to target volumes and normal tissue

  5 years

Secondary Outcomes (3)

• Time for radiotherapy replanning

  5 years

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

  5 years

• Toxicity associated with the adaptive radiotherapy technique.

  5 years

Study Arms (1)

Post-Operative adaptive radiotherapy

EXPERIMENTAL

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.

Radiation: Post-operative Adaptive Radiation Therapy

Interventions

Post-operative Adaptive Radiation Therapy RADIATION

Also known as: 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.

Post-Operative adaptive radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Charles N Catton, MD

  The Princess Margaret Cancer Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: January 14, 2014
• Study Start: July 1, 2013
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

CA (1)