Preop Conformal Radiotherapy - Prostate
Primary Purpose
Prostatic Neoplasm
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Pre-Operative Conformal Radiotherapy
Sponsored by

About this trial
This is an interventional treatment trial for Prostatic Neoplasm
Eligibility Criteria
Histologically confirmed carcinoma of the prostate High risk localized disease defined as clinical T1 or T2 plus [ (i) Gleason ¡Ý7, PSA>10 ng/ml and <35 ng/ml OR (ii) PSA >15 ng/ml and less <35 ng/ml (any Gleason) ] No evidence of pelvic lymph node metastases on CT scan within 4 months of surgery No evidence of distant metastases on bone scan within 4 months of surgery No contraindication to pelvic radiation therapy
Sites / Locations
- University Health Network Princess Margaret Hospital
Outcomes
Primary Outcome Measures
To document the feasibility of pre-operative conformal radiation therapy in patients undergoing radical prostatectomy for localized prostate cancer who are at high risk for having local extra-prostatic disease at time of surgery.
Secondary Outcome Measures
Full Information
NCT ID
NCT00252447
First Posted
November 9, 2005
Last Updated
August 10, 2010
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00252447
Brief Title
Preop Conformal Radiotherapy - Prostate
Official Title
A Pilot Study of Pre-Operative Conformal Radiotherapy in Patients With Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
4. Oversight
5. Study Description
Brief Summary
Radical prostatectomy and radical radiation therapy remain the standard treatment approaches for patients with clinically localized prostate cancer (T1, T2).Radical prostatectomy is most effective when the disease is organ confined at the time of surgery. However, in many series up to 60% of patients have positive resection margins at the time of surgery and there is evidence to suggest that these patients may not be curable by surgery alone. A number of preoperative clinical variables including clinical stage, serum Prostate Specific Antigen (PSA) and Gleason scorea re helpful in determining the probability of finding organ confined disease at the time of syrgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Pre-Operative Conformal Radiotherapy
Primary Outcome Measure Information:
Title
To document the feasibility of pre-operative conformal radiation therapy in patients undergoing radical prostatectomy for localized prostate cancer who are at high risk for having local extra-prostatic disease at time of surgery.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Histologically confirmed carcinoma of the prostate
High risk localized disease defined as clinical T1 or T2 plus [ (i) Gleason ¡Ý7, PSA>10 ng/ml and <35 ng/ml OR (ii) PSA >15 ng/ml and less <35 ng/ml (any Gleason) ]
No evidence of pelvic lymph node metastases on CT scan within 4 months of surgery
No evidence of distant metastases on bone scan within 4 months of surgery
No contraindication to pelvic radiation therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Padraig Warde, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Preop Conformal Radiotherapy - Prostate
We'll reach out to this number within 24 hrs