Clincosm LogoSign in Get a demo

External Beam Radiation Therapy - Target Volume

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00230438
Collaborator
Princess Margaret Hospital, Canada (Other)
27
Enrollment
1
Location
1
Arm
99.9
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: External Beam Radiotherapy
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2005
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: External Beam Radiation Therapy

Procedure: External Beam Radiotherapy

Outcome Measures

Primary Outcome Measures

  1. To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy [After data acquisition]

Secondary Outcome Measures

  1. To compare the reproducibility of clinical target volume and rectal wall volume delineation on MRI and CT. [After data acquisition]

  2. 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. [After data acquisition]

  3. 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. [After data acquisition]

  4. To determine the optimal radiation technique that encompasses the MRI-defined PTV whilst respecting bowel and bladder dose constraints. [After data acquisition]

  5. 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. [After data acquisition]

  6. To explore the utility of IV contrast for the delineation of gross tumor recurrence and normal blood vessels. [After data acquisition]

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

Sponsors and Collaborators

  • University Health Network, Toronto
  • Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Cynthia Menard, MD, Princess Margaret Hospital, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00230438
Other Study ID Numbers:
  • UHN REB 04-0759-CE
First Posted:
Sep 30, 2005
Last Update Posted:
Jan 6, 2014
Last Verified:
Jan 1, 2014
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jan 6, 2014