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

September 28, 2005
January 3, 2014
January 2005
May 2013   (final data collection date for primary outcome measure)
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 ]
To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy
Complete list of historical versions of study NCT00230438 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
External Beam Radiation Therapy - Target Volume
A Pilot Study to Develop a Technique for External Beam Radiotherapy After Radical Prostatectomy Based on MRI-Delineation of the Clinical Target Volume

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostatic Neoplasms
Procedure: External Beam Radiotherapy
Experimental: External Beam Radiation Therapy
Intervention: Procedure: External Beam Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00230438
UHN REB 04-0759-CE
Not Provided
University Health Network, Toronto
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Cynthia Menard, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP