An experimental study in men with prostate cancer to investigate the drug Zoreline 10.8 mg on its effects on the human body and safety.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 142

Inclusion Criteria

1.Males aged 18 years (inclusive) or above
2.Histologically confirmed prostate adenocarcinoma and indicated for ADT. This includes but is not limited to subjects suffering from Localized intermediate-risk or high-risk Prostate Cancer (having a clinical state of T2b and =T2c) and subjects with Locally Advanced Prostate Cancer (having T3-4 as clinical state) [Mottet, 2018; NICE Guideline, 2014]. Previous prostatectomy and/or prostate radiotherapy is allowed.
3.Willing to give informed consent in writing
4.Willing and able to attend the scheduled study visits and to comply with the study procedures
5.Testosterone level > 250 ng/dL
6.PSA level = 4 ng/mL
Exception: for subjects who have had previous prostatectomy and/or prostate radiotherapy, all PSA levels are allowed.
7.Life expectancy > 1 year
8.Body Mass Index between 18.5 and 35.0 kg/m2 inclusive
9.ECOG score of =2

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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1.Hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including gonadotrophin-releasing hormone (GnRH) receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, 5 alpha reductase inhibitors) within 6 months prior to the screening visit (with a maximum of 2 previous treatment cycles allowed in case of GnRH analog treatment)
2.Scheduled for prostatectomy or prostate radiotherapy during study period
3.Any subject at risk as per Investigator’s judgement for urinary obstruction or spinal cord compression due to potential testosterone surge
4.Alanine aminotransferase (ALT) or aspartate transaminase (AST) =2x upper limit of normal (ULN)
5.Estimated glomerular filtration rate (eGFR), using the modification of diet in renal disease (MDRD) equation, <50 mL/min/1.73m2 at screening visit
6.Has received an investigational drug within the last 28 days before Visit 2 (Cycle 1 Day 1) or longer if considered by the Investigator to possibly influencing the outcome of this study
7.History or presence of any malignancy other than adequately 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], hepatic, renal, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study at Investigator discretion. A profound risk-benefit assessment should be done when the subject is suffering from diabetes mellitus, osteoporosis or cardiovascular disease because of possible adverse events
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 medication
10.Hypersensitivity to GnRH and its analogues
11.Other abnormal laboratory results which in the judgment of the Investigator would affect the subject's health or the outcome of the study
12.Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation

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

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