a research study to compare the standard treatment and the study drug (degarelix) in combination with radiotherapy in patients with locally advanced prostate cancer.
- Conditions
- very high risk localized or locally advanced prostate cancerMedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-005098-19-AT
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer (EORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 885
? Histologically confirmed diagnosis of prostate adenocarcinoma diagnosed on a systematic ultrasound guided biopsy of the prostate containing at least 8 cores. An MRI-fusion biopsy is allowed if taken because a previous biopsy was negative. A TURP specimen pathology is allowed. PSA = 10 ng/ml and two of the following 4 risk factors for relapse:
? PSA =20 ng/ml,
? Gleason sum =8,
? cN1 (regional LN with a short axis length >10mm by CT scan or MRI) or pathologically confirmed lymph nodes (pN1) (see Appendix H),
? cT3-T4 (by MRI or core biopsy)
(ie. If PSA=20 ng/ml then only one of the other 3 risk factors is needed)
? M0 by standard imaging work-up (see chapter 6 for specification of standard work-up)
? Testosterone = 200 ng/dl
? Adequate renal function: calculated creatinine clearance = 50 mL/min (Appendix D)
? Magnesium and potassium within normal limits of the institution or corrected to within normal limits prior to the first dose of treatment.
? Patients with prolonged QT-intervals due to prescribed Class IA (quinidine, procainamide) or Class III (amiodarone, sotalol) antiarrhythmic medication must be carefully evaluated for GnRH-agonist or GnRH antagonist use, because these drugs may prolong the QT-interval.
? Clinically normal cardiac function for-left ventricular ejection fraction (= 50%) as assessed either by multi-gated acquisition scan or cardiac ultrasound, triplicate 12 lead ECG without clinically relevant abnormalities. WHO Performance status 0-1 (see Appendix C)
? Age = 18 years and = 80 years
? Participants who have partners of childbearing potential must use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after last dose of study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
? Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
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 295
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 590
? Previous use of androgen deprivation therapy, antiandrogens. 5-alpha reductase inhibitors are allowed if interrupted for more than 6 months prior to entering the study
? History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angiodema.
? Hypersensitivity towards the investigational drug
? The following biological parameters :AST, ALT, total bilirubin, prothrombin time, serum albumin above upper level of normal range No severe hepatic impairment (Child Pugh C)
? History of gastro-intestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the protocol treatment.
? History of pituitary or adrenal dysfunction
? Uncontrolled diabetes mellitus
? History of ulcerative colitis, Crohn's Disease, ataxia, telangiectasia, systemic lupus erythematosus, or Fanconi anemia.
? Clinically significant heart disease as evidence myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
? Coronary revascularization (PCI or multivessel CABG), carotid artery or iliofemoral artery revascularizaton (percutaneous or surgical procedure) within the last 30 days prior to entering the trial
? Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes ventricular arrhythmias (eg, heart failure, hypokalemia, or a family history of a long QT syndrome), a QT or corrected QT (QTc) interval >450 ms at baseline, or intake of medications that prolong the QT/QTc interval
? Uncontrolled hypertension (systolic BP = 160 mmHg or diastolic BP = 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
? Prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin), or the patient has been free of malignancy for a period of 3 years prior to first dose of study drug(s). Prior history of bladder cancer excludes the patient
? Prior radical prostatectomy (TURP or suprapubic adenomectomy for benign prostatic hyperplasia is allowed)
? Any contraindication to external beam radiotherapy
? Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method