Prostatic Neoplasm
Conditions
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.
Interventions
PROCEDUREPre-Operative Conformal Radiotherapy
Sponsors
Princess Margaret Hospital, Canada
University Health Network, Toronto
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada
Outcome results
None listed