Study testing the drug ODM-201 vs standard treatment in men with hormone naive prostate cancer
- Conditions
- Hormone Naive Prostate CancerMedDRA version: 21.1Level: PTClassification code 10071119Term: Hormone-dependent prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004334-17-IT
- Lead Sponsor
- EORTC AISBL/IVZW
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 250
• Aged 18 years or older
• Histologically confirmed prostate cancer (all stages) for whom continuous ADT is indicated for a minimum period of 24 weeks
• Patient presenting with a maximum of 4 confirmed metastatic lesions, including bone, extra-pelvic lymph nodes, and > 2 cm pelvic lymph nodes by imaging (contrast enhanced CT scans or MRI, Tc-99m BS according to local practice). Visceral metastases are excluded
• Asymptomatic for metastatic prostate cancer; urinary symptoms are allowed
• Baseline total testosterone = 8 nmol/L or 230 ng/dL
• Two subsequent PSA values = 2 ng/ml, done in the past 3 months with a minimum of 2 weeks between the two, with the second being equal to or higher than the first
• WHO performance status (PS) of 0-1
• G8 score = 14 for patients aged = 70 years old
• A life expectancy of at least 12 months
• Able to swallow the study drug whole as a tablet
• Adequate bone marrow function (absolute neutrophil count (ANC) = 1.5 10^9/L; hemoglobin = 10.0 g/dl; platelets = 100 10^9/L)
• Adequate renal function: creatinine = 1.5 x ULN
• Albumin > 25 g/L
• Adequate hepatic function:
- Bilirubin: total bilirubin = 1.5 × upper limit of normal (ULN).
- AST and/or ALT = 2.5 × ULN.
NOTE: patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry (except for serum creatinine) are acceptable.
• Normal 12-lead ECG as per local standard
• Patients of reproductive potential should use adequate birth control measures, during the study treatment period and for at least 3 months after the last 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
• Absence of any 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 registration in the trial
• 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 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125
• Previously or currently receiving hormonal therapy with intent to treat prostate cancer disease (surgical castration or other hormonal manipulation, e.g. LHRH agonists, LHRH antagonists, anti-androgens, oestrogens, 5a-reductase inhibitor). For patients that have received (neo)adjuvant ADT before radiotherapy, it should have been stopped for more than 1 year
• Prior use of investigational agents that block androgen synthesis or block androgen receptor
• Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto)
• Has received systemic glucocorticoids within 24 weeks prior to enrollment or is expected to require systemic glucocorticoids during the study period, unless determined to be medically necessary by the investigator for other indications than prostate cancer.
• Radiation therapy for treatment of the primary tumor within 3 months prior to enrollment
• Use of an investigational agent within 4 weeks prior to enrollment is not allowed.
• Gastrointestinal disorder affecting absorption (e.g. gastrectomy, active peptic ulcer disease within 3 months prior to enrollment)
• Known hypersensitivity to the study treatment or any of its ingredients (refer to Investigator's brochure).
• Severe or uncontrolled concurrent disease, infection or co-morbidity including active viral hepatitis, known human immunodeficiency virus infection with detectable viral load (HIV) or chronic liver disease (Child Pugh C, see Appendix J)
• History of prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e. pTis, pTa, and pT1) is allowed, as well as any other cancer from which the patient has been disease-free for a period of at least 5 years.
• Clinically significant cardiovascular disease including:
- Myocardial infarction within six months prior to randomization
- Uncontrolled angina within 3 months prior to randomization
- Coronary/peripheral artery bypass within 6 months prior to randomization
- Stroke within 6 months prior to randomization
- Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is = 45%
- History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
- History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
• Uncontrolled hypertension as indicated by a resting systolic blood pressure >170 mm Hg or diastolic blood pressure >105 mm Hg at the screening visit
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