Prostatic carcinoma with pathological stage pT3a-b R0-1 N0M0 / pT2R1 N0M0, Gleason score 5-10 MedDRA version: 14.1 Level: LLT Classification code 10036955 Term: Prostatic carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Eligard 45 mg
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: LEUPRORELIN ACETATE
CAS Number: 74381536
Concentration unit: mg milligram(s)
Concent
Sponsors
European Organisation for Research and Treatment of Cancer
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Patients with clinical stage cT1-2-3aN0M0 prostate cancer 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 = 30ng/ml - Presenting after radical prostatectomy (all techniques allowed:retropubic, laparoscopic or perineal) with: *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 XML File Identifier: PCovc+DvFWSFlF2RzJBwTuErsfw= Page 11/25 dissection or cN0 (by MRI) pNx. *Post-operative PSA undetectable (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 - Medically fit to receive radiation therapy. Preferably the patient should be fully continent at randomization. - 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. - To enter the trial in the "immediate post-operative" setting * External irradiation must be planned to start within 26 weeks after surgery. Randomization should ideally take place within 22 to maximum 25 weeks after surgery and minimum 1 week before the start of the post-operative treatment and the PSA should be undetectable or very low ( 0.1 ng/ml and = 0.5 ng/ml; * Or, in the case where the 3rd value is not > 0.1 ng/ml, by 4 PSA measurements (nadir and 3 consecutive increases measured at least 2 weeks apart). * Final measurement should be within 2 weeks before randomization and = 0.5 ng/ml. Salvage treatment must be planned to start within 2 months after biochemical failure. Randomization should take place minimum 1 week before starting the salvage treatment. 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the potential benefit of a combined adjuvant treatment consisting of short term androgen suppression in addition to immediate or early salvage post-operative RT in comparison to immediate or early salvage post-operative RT alone, for improving the biochemical progression free survival of patients who have undergone radical prostatectomy for cT1-2-3a cN0M0 prostate cancer with baseline PSA = 30 ng/ml and who present post-operatively with pathologic stage pT2 R1 / pT3a-b R0-1 cN0M0, Gleason score 5-10 and an undetectable or very low < 0.2 ng/ml) post-operative PSA.;Secondary Objective: A translational research study involving proteomics and collection of tissue micro-arrays for future research will be carried out in selected centers. ;Primary end point(s): The primary trial endpoint is biochemical progression-free survival;Timepoint(s) of evaluation of this end point: The distant-metastases free survival is counted from the day of randomization to the day of the first record of appearance of distant metastases or of death of any cause. Second cancers, biochemical progression, clinical evidence of loco-regional only progression are not considered events in terms of this endpoint. Patients without any of the events of interest are censored at the date of the last follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints considered in this study are the acute and late treatment toxicity, clinical progression-free survival, overall survival, distant-metastatis free survival and quality of life. ;Timepoint(s) of evaluation of this end point: Side effects of the treatment will be assessed using the International Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 scoring system. | — |
Countries
Belgium, France, Netherlands, Spain, Switzerland
Contacts
Public ContactProject - Budget & Regulatory Dept
EORTC
Outcome results
None listed