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Preop Conformal Radiotherapy - Prostate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00252447
First Posted: November 11, 2005
Last Update Posted: August 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
  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: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00252447     History of Changes
Other Study ID Numbers: UHN REB 01-0483-C
First Submitted: November 9, 2005
First Posted: November 11, 2005
Last Update Posted: August 11, 2010
Last Verified: August 2010

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