Status:
COMPLETED
Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
Lead Sponsor:
Camurus AB
Conditions:
Prostate Cancer
Eligibility:
MALE
40-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive leuprolide ace...
Eligibility Criteria
Inclusion
- Men ≥40 and ≤85 years of age
- Histological or cytological proven adenocarcinoma of the prostate requiring hormone therapy
- Life expectancy over 12 months
- World Health Organisation/ The Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1 or 2
- Adequate and stable renal function
- Adequate and stable hepatic function
Exclusion
- Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction
- Serum Testosterone levels below 150 ng/dL at Screening visit
- Medical or radiological prostate cancer treatments within 2 months prior to the Screening visit
- Surgical treatment of prostate cancer within 2 weeks prior to the Screening visit
- Prior orchiectomy, hypophysectomy, or adrenalectomy
- Prior use of LHRH agonists within 12 months prior to the Screening visit and during the study
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT02212197
Start Date
September 1 2014
End Date
March 1 2016
Last Update
April 25 2017
Active Locations (7)
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1
Docrates Cancer Center
Helsinki, Finland
2
University Hospital of Helsinki, Department of Urology
Helsinki, Finland
3
Tampere University Hospital, Department of Urology
Tampere, Finland
4
University Hospital of Turku, Department of Urology
Turku, Finland