Prostatectomy Adaptive Radiation Therapy (ART)

NCT ID: NCT02034955

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2023-05-16

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Post-operative Adaptive Radiation Therapy

Intervention Type RADIATION

Interventions

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Post-operative Adaptive Radiation Therapy

Intervention Type RADIATION

Other Intervention Names

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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.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles N Catton, MD

Role: PRINCIPAL_INVESTIGATOR

The Princess Margaret Cancer Foundation

Locations

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University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UHN REB 12-5318-C

Identifier Type: -

Identifier Source: org_study_id

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