Preop Conformal Radiotherapy - Prostate

NCT00252447 | Completed Phase 1

• 1 other identifier: UHN REB 01-0483-C
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Pre-Operative Conformal Radiotherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

University Health Network Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Padraig Warde, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: May 1, 2000
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 11, 2010

Record last verified: 2010-08

Locations

CA (1)