Post-operative external radiotherapy combined with concomitant and adjuvant hormonal treatment versus post-operative external radiotherapy alone in pathological stage pT3a-b R0-1 N0M0 / pT2R1 N0M0, Gleason score 5-10 prostatic carcinoma. A Phase III study

European Organisation for Research and Treatment of Cancer0 sites86 target enrollmentApril 28, 2009

Overview

No summary available.

Registry

who.int

Start Date

April 28, 2009

End Date

January 5, 2014

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

European Organisation for Research and Treatment of Cancer

•\- Patients with clinical stage cT1\-2\-3aN0M0 prostate cancer (UICC TNM 2002, see Appendix D) clinically assessed after a preoperative work\-up including physical examination, chest X\-ray, bone scan, CT scan or MRI of the entire pelvis and abdomen.
•\- Pre\-operative PSA \= 5 x upper limit of normal (ULN).
•\- Presenting after radical prostatectomy (all techniques allowed: retropubic, laparoscopic or perineal) with (see pathological assessment protocol in Appendix E):
•\*Gleason sum 5\-10
•\*Pathologic stage pT2R1 (positive surgical margins with at least a tumor trans\-section higher than 2 mm) or pT3a\-b (irrespective of margin status)
•\*Negative lymph node (LN) status (pN0\) by LN sampling or LN dissection. Unknown
•pathological LN status (pNx, i.e. omission of LN sampling or LN dissection) is not allowed except for patients classified as cT \= cT1c with baseline PSA \= 10ng/ml and Gleason score \< 7 and positive core biopsies \< 50%, provided the total number of random biopsies is at least 12
•\*Undetectable post\-operative PSA (PSA is below the detection level of the laboratory) within 3 months of surgery
•\- Age \= 80 years.
•\- WHO performance status 0\-1\.

•\- prior pelvic irradiation.
•\- prior bilateral orchiectomy.
•\- prior chemotherapy within the 5 years prior to randomization.
•\- prior hormonal treatment except neo\-adjuvant treatment lasting \= 3 months.
•\- other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease free for at least 5 years.
•\- psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule; those conditions should be discussed with the patient before randomization in the trial.