A study in males with prostate cancer performed in several centers to assess the blood levels after injection of two subcutaneous implants containing 10.8 mg gosereli
- Conditions
- prostate cancerMedDRA version: 18.1Level: 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
- EUCTR2015-001756-30-BG
- Lead Sponsor
- ovalon S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 58
1. Males Age 18 years (inclusive) or above
2. Histologically confirmed prostate adenocarcinoma and indicated for androgen deprivation therapy (ADT). Previous prostatectomy and/or prostate radiotherapy are allowed.
3. Good physical and mental health as judged by the investigator determined by medical history, physical examination, clinical laboratory and vital signs
4. Willing to give informed consent in writing
5. Willing and able to attend the scheduled study visits and to comply with the study procedures
6. Testosterone level > 2.5 ng/mL at screening
7. PSA level =4ng/mL.
Exception: for patients who have had previous prostatectomy and/or prostate radiotherapy, all PSA levels are allowed.
8. Life expectancy > 1 year assessed at screening or within the last month
9. Body Mass Index between 18.5 and 35kg/m2 inclusive
10. ECOG score of =2 measured at screening
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 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
1. Previous or current hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, 5 alpha reductase inhibitors) within 6 months prior to the screening visit. All other prohibited medications that are listed in Appendix 3 should not have been administered within the last 3 months prior the study drug administration
2. Scheduled for prostatectomy or prostate radiotherapy during study period
3. Alanine aminotransferase (ALT) / serum glutamic-pyruvic transaminase (SGPT) or aspartate transaminase (AST) / serum glutamic oxaloacetic transaminase (SGOT) =2x upper limit of normal (ULN) or GGT =2.5 x upper limit of normal
4. Evidence (including clinically significant abnormal bilirubin and/or albumin values) or history for chronic hepatic disease
Moderate or severe chronic kidney disease with an estimated glomerular filtration rate (eGFR), using the modification of diet in renal disease (MDRD) equation, <60 mL/min/1,73m2
6. Has received an investigational drug within the last 28 days before the Screening visit or 5 times the half-life of the drug whichever is longer if considered by the investigator to possibly influencing the outcome of this trial
7. History or presence of any malignancy other than prostate cancer and treated squamous cell /basal cell carcinoma of the skin within the last five years
8. Have an unstable medical condition or chronic disease (including history of neurological [including cognitive], cardiovascular, gastrointestinal, pulmonary, or endocrine disease), that could confound interpretation of the study at investigator discretion
9. History of severe uncontrolled asthma, anaphylactic reactions, or severe urticarial and/or angioedema, and particularly, history of hypersensitivity towards any components of the study drug
10. Other abnormal laboratory results which in the judgment of the investigator would affect the patient's health or the outcome of the trial
11. Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
12. Have a prolonged QTc interval defined as mean QTcB > 450 ms at Screening. If the mean value of QTcB interval from the three measurements is above 450 ms, another triplicate ECG could be recorded once on the same day
13. Have a family history for prolonged QT interval including a history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or a personal history of syncope
14. Evidence or history for significant active cardiac disease (e.g., congestive heart failure, mitral valve regurgitation, endocarditis, coronary artery heart disease), or symptoms of angina pectoris or transient ischaemic attacks
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