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Preop Conformal Radiotherapy - Prostate

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00252447
First received: November 9, 2005
Last updated: August 10, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasm
 Procedure: Pre-Operative Conformal Radiotherapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Pre-Operative Conformal Radiotherapy in Patients With Radical Prostatectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

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.

Estimated Enrollment: 15
Study Start Date: May 2000
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252447

Locations
Canada, Ontario
University Health Network Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Padraig Warde, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00252447     History of Changes
Other Study ID Numbers: UHN REB 01-0483-C
Study First Received: November 9, 2005
Last Updated: August 10, 2010
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013