A clinical trial in patients with prostate cancer to investigate the clinical efficacy and safety of a new hormone implant (AMW Leuprorelin 10.72 mg implant) that is to be applied twice every 84 days in every participant

Conditions: prostate cancer
MedDRA version: 14.1Level: 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: EUCTR2011-006014-14-DE

Lead Sponsor: AMW GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

1.Males aged 18 years or older
2.Diagnosis of locally advanced, recidivated or metastatic carcinoma of the prostate suitable for hormonal manipulation including patients with rising PSA after having undergone surgery or radiotherapy with curative intention
3.Normal testosterone values (> 8 nmol/L or > 2.3 ng/mL) at screening according to immunoassay
4.Life expectancy of at least six months
5.The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form
6.The patient is able to understand and follow instructions and is able to participate in the study for the entire study period
7.Patient has given his written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures.

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Hypersensitivity to leuprorelin or to other GnRH analogues
2.Treatment with GnRH analogues completed less than 6 months prior to the baseline visit
3.Patients considered being candidates for curative therapy i.e. radical prostatectomy or radiotherapy within 6 months from inclusion
4.Cancer disease within the last 5 years except prostate cancer, and except surgically removed basocellular or squamous cell carcinoma of the skin
5.Patients with clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or any infectious disorder or any other condition including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator
6.Mental incapacity or language barriers precluding adequate understanding or co-operation
7.Previous participation in this study
8.Simultaneous or less than 12 weeks earlier participation in another clinical trial
9.Known allergy against one of the ingredients in the test preparation.