Preop Conformal Radiotherapy - Prostate

Prostatic Neoplasm Clinical Trial

Official title:

A Pilot Study of Pre-Operative Conformal Radiotherapy in Patients With Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252447
• Other study ID #: UHN REB 01-0483-C
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 9, 2005
• Last updated: August 10, 2010
• Start date: May 2000
• Est. completion date: March 2009

Study information

• Verified date: August 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Procedure:
• Pre-Operative Conformal Radiotherapy

Locations

Country	Name	City	State
Canada	University Health Network Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.