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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
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
November 9, 2005
Last Updated
August 10, 2010
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
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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

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