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

Phase 1

• Conditions: Prostatic carcinoma with pathological stage pT3a-b R0-1 N0M0 / pT2R1 N0M0, Gleason score 5-10; MedDRA version: 9.1Level: LLTClassification code 10036955Term: Prostatic carcinoma

• Registration Number: EUCTR2006-002772-17-FR
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-28
• Study Completion: 2014-01-05
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 86

Inclusion Criteria

- 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.
- Normal organ functions as shown by all of the following (measured within 2 weeks prior to randomization):
*hemoglobin = 110 g/l
*WBC =3 x 109/l
*platelet count = 100 x 109/l
- External irradiation must be planned to start within 4 months after surgery. Randomization should take place as shortly as possible before the start of the treatment and a maximum of 3 months after surgery, and the patient must be fully continent.
- Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Patients can be randomized in this trial only once.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified