External Beam Radiation Therapy - Target Volume

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230438
• Other study ID #: UHN REB 04-0759-CE
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2005
• Last updated: January 3, 2014
• Start date: January 2005
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Procedure:
• External Beam Radiotherapy

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy		After data acquisition	No
Secondary	To compare the reproducibility of clinical target volume and rectal wall volume delineation on MRI and CT.		After data acquisition	No
Secondary	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	No
Secondary	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	No
Secondary	To determine the optimal radiation technique that encompasses the MRI-defined PTV whilst respecting bowel and bladder dose constraints.		After data acquisition	No
Secondary	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	No
Secondary	To explore the utility of IV contrast for the delineation of gross tumor recurrence and normal blood vessels.		After data acquisition	No