External Beam Radiation Therapy - Target Volume

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00230438
First received: September 28, 2005
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Prostatic Neoplasms
Procedure: External Beam Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy [ Time Frame: After data acquisition ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the reproducibility of clinical target volume and rectal wall volume delineation on MRI and CT. [ Time Frame: After data acquisition ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine the optimal radiation technique that encompasses the MRI-defined PTV whilst respecting bowel and bladder dose constraints. [ Time Frame: After data acquisition ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To explore the utility of IV contrast for the delineation of gross tumor recurrence and normal blood vessels. [ Time Frame: After data acquisition ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: January 2005
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: External Beam Radiation Therapy Procedure: External Beam Radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230438

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00230438     History of Changes
Other Study ID Numbers: UHN REB 04-0759-CE
Study First Received: September 28, 2005
Last Updated: January 3, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014