NCT00230438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2014

Enrollment Period

8.3 years

First QC Date

September 28, 2005

Last Update Submit

January 3, 2014

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy

    After data acquisition

Secondary Outcomes (6)

  • To compare the reproducibility of clinical target volume and rectal wall volume delineation on MRI and CT.

    After data acquisition

  • 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

  • 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

  • To determine the optimal radiation technique that encompasses the MRI-defined PTV whilst respecting bowel and bladder dose constraints.

    After data acquisition

  • 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

  • +1 more secondary outcomes

Study Arms (1)

External Beam Radiation Therapy

EXPERIMENTAL
Procedure: External Beam Radiotherapy

Interventions

External Beam RadiotherapyPROCEDURE
External Beam Radiation Therapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Cynthia Menard, MD

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2005

First Posted

September 30, 2005

Study Start

January 1, 2005

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 6, 2014

Record last verified: 2014-01

Locations

CA(1)