Immediate or early salvage post-operative externalradiotherapy combined with concomitant and adjuvanthormonal treatment versus immediate or early salvage postoperative external radiotherapy alone in pT3a-b R0-1 cN0M0 / pT2R1 cN0M0, 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: 14.0Level: LLTClassification code 10036955Term: Prostatic carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-01
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 600

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 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 (< 0.2 ng/ml) within 2 weeks before
randomization.
- To enter the trial in the early salvage setting
* biochemical failure defined by rising PSA documented
* Either by 3 PSA measurements (nadir and 2 consecutive increases measured at least 2 weeks apart) with final PSA value > 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
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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the potential benefit, in terms of biochemical progression free survival, of a<br>combined adjuvant treatment consisting of short term androgen suppression in addition to RT in comparison to RT alone, delivered either<br>immediately following prostatectomy or in an early salvage setting, when the PSA starts to rise above undetectable levels. The population<br>considered consists of patients who had a baseline PSA = 30 ng/ml, who underwent an operation for cT1-2-3a cN0M0 prostate cancer and who presented 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.

Secondary Outcome Measures

Name	Time	Method
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-metastasis free survival and quality of life.