Clinical trial NCT00230438: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-09-30
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy
timeFrame: After data acquisition
Secondary outcomes:
measure: To compare the reproducibility of clinical target volume and rectal wall volume delineation on MRI and CT.
timeFrame: After data acquisition
measure: 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.
timeFrame: After data acquisition
measure: 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.
timeFrame: After data acquisition
measure: To determine the optimal radiation technique that encompasses the MRI-defined PTV whilst respecting bowel and bladder dose constraints.
timeFrame: After data acquisition
measure: 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.
timeFrame: After data acquisition
measure: To explore the utility of IV contrast for the delineation of gross tumor recurrence and normal blood vessels.
timeFrame: After data acquisition
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Cynthia Menard, MD
role: PRINCIPAL_INVESTIGATOR
References: