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External Beam Radiation Therapy - Target Volume

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
External Beam Radiotherapy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Patients following radical prostatectomy for prostate adenocarcinoma with one or more of the following adverse features: pT2 + positive surgical margins ) pT3 ) PSA ≤ 2ng/ml Persistently elevated PSA at 3 months ) Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse Patients being planned for radiation therapy No evidence of distant metastases Age ≥ 18 years ECOG performance status 0 or 1 Informed consent Exclusion Criteria: Contraindications to MRI Patients weighing >136 kgs (weight limit for the scanner tables) Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI. Severe claustrophobia Inflammatory bowel disease or collagen vascular disease Previous colorectal surgery Previous pelvic radiotherapy

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

External Beam Radiation Therapy

Arm Description

Outcomes

Primary Outcome Measures

To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy

Secondary Outcome Measures

To compare the reproducibility of clinical target volume and rectal wall volume delineation on MRI and CT.
To compare the location of the urethral anastomosis defined on MRI as compared to a fiducial marker placed under TRUS-guidance adjacent to the anastomosis.
To measure the amount of intrafraction movement and deformity of the prostatic bed and seminal vesicles with current bowel regimen of daily milk of magnesia using cinematic MRI.
To determine the optimal radiation technique that encompasses the MRI-defined PTV whilst respecting bowel and bladder dose constraints.
To measure the amount of interfraction movement and deformity of the bladder, rectum, and surgical clips within the operative bed using daily cone-beam CT imaging.
To explore the utility of IV contrast for the delineation of gross tumor recurrence and normal blood vessels.

Full Information

First Posted
September 28, 2005
Last Updated
January 3, 2014
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00230438
Brief Title
External Beam Radiation Therapy - Target Volume
Official Title
A Pilot Study to Develop a Technique for External Beam Radiotherapy After Radical Prostatectomy Based on MRI-Delineation of the Clinical Target Volume
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

5. Study Description

Brief Summary
Delivery of conformal radiation therapy following radical prostatectomy is limited by the inability to define the clinical target volume (CTV). This stems from a poor understanding of patterns of local recurrence and limitations of standard imaging techniques.Magnetic Resonance Imaging (MRI) is a promising modality for imaging the prostatic bed following radical prostatectomy. MRI provides more detailed postoperative anatomy to guide CTV delineation, the ability to document local recurrence patterns, and a method to assess intrafraction prostatic bed motion and deformity to define appropriate planning target volume margins. The aim of this pilot study is to develop a technique for external beam radiation therapy (EBRT) following radical prostatectomy based on MRI-delineation of the CTV. Twenty patients will be enrolled in this pilot, development phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External Beam Radiation Therapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
External Beam Radiotherapy
Primary Outcome Measure Information:
Title
To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy
Time Frame
After data acquisition
Secondary Outcome Measure Information:
Title
To compare the reproducibility of clinical target volume and rectal wall volume delineation on MRI and CT.
Time Frame
After data acquisition
Title
To compare the location of the urethral anastomosis defined on MRI as compared to a fiducial marker placed under TRUS-guidance adjacent to the anastomosis.
Time Frame
After data acquisition
Title
To measure the amount of intrafraction movement and deformity of the prostatic bed and seminal vesicles with current bowel regimen of daily milk of magnesia using cinematic MRI.
Time Frame
After data acquisition
Title
To determine the optimal radiation technique that encompasses the MRI-defined PTV whilst respecting bowel and bladder dose constraints.
Time Frame
After data acquisition
Title
To measure the amount of interfraction movement and deformity of the bladder, rectum, and surgical clips within the operative bed using daily cone-beam CT imaging.
Time Frame
After data acquisition
Title
To explore the utility of IV contrast for the delineation of gross tumor recurrence and normal blood vessels.
Time Frame
After data acquisition

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients following radical prostatectomy for prostate adenocarcinoma with one or more of the following adverse features: pT2 + positive surgical margins ) pT3 ) PSA ≤ 2ng/ml Persistently elevated PSA at 3 months ) Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse Patients being planned for radiation therapy No evidence of distant metastases Age ≥ 18 years ECOG performance status 0 or 1 Informed consent Exclusion Criteria: Contraindications to MRI Patients weighing >136 kgs (weight limit for the scanner tables) Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI. Severe claustrophobia Inflammatory bowel disease or collagen vascular disease Previous colorectal surgery Previous pelvic radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Menard, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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External Beam Radiation Therapy - Target Volume

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