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Prostatectomy Adaptive Radiation Therapy (ART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034955
Recruitment Status : Active, not recruiting
First Posted : January 14, 2014
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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
Prostate Cancer Radiation: Post-operative Adaptive Radiation Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
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 : July 2013
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change in radiation dose delivered to target volumes and normal tissue [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Time for radiotherapy replanning [ Time Frame: 5 years ]
  2. Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow. [ Time Frame: 5 years ]
    Feasibility will be assessed by the time required to perform the adaptive intervention

  3. Toxicity associated with the adaptive radiotherapy technique. [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034955


Locations
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Canada, Ontario
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Charles N Catton, MD University Health Network--Princess Margaret Cancer Centre
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02034955    
Other Study ID Numbers: UHN REB 12-5318-C
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Keywords provided by University Health Network, Toronto:
Prostate Cancer
Adaptive Radiotherapy
Prostatectomy
Patients who had a prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases