Clincosm LogoSign in Get a demo

Prostatectomy Adaptive Radiation Therapy (ART)

Sponsor
University Health Network, Toronto (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02034955
Collaborator
(none)
21
Enrollment
1
Location
1
Arm
111
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Post-operative Adaptive Radiation Therapy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Feasibility Study of Post-operative Adaptive Radiation Therapy for Localized Prostate Cancer
Study Start Date :
Jul 1, 2013
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Post-Operative adaptive radiotherapy

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
Other Names:
  • 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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in radiation dose delivered to target volumes and normal tissue [5 years]

    Secondary Outcome Measures

    1. Time for radiotherapy replanning [5 years]

    2. 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

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network, Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Charles N Catton, MD, University Health Network--Princess Margaret Cancer Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT02034955
    Other Study ID Numbers:
    • UHN REB 12-5318-C
    First Posted:
    Jan 14, 2014
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by University Health Network, Toronto
    Prostate Cancer
    Adaptive Radiotherapy
    Prostatectomy
    Patients who had a prostatectomy
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Oct 6, 2021