Preop Conformal Radiotherapy - Prostate

University Health Network, Toronto

Status and phase

Completed

Phase 2

Phase 1

Conditions

Prostatic Neoplasm

Treatments

Procedure: Pre-Operative Conformal Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00252447

UHN REB 01-0483-C

Details and patient eligibility

About

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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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