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Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer

Information source: Camurus AB
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: leuprolide acetate (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Camurus AB

Official(s) and/or principal investigator(s):
Teuvo Tammela, Professor, Principal Investigator, Affiliation: Tampere University Hospital, Department of Urology


The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 q1m versus Eligard, in patients with prostate cancer. All patients will receive leuprolide acetate administered subcutaneously once monthly during 3 months.

Clinical Details

Official title: A Phase II, Open Label, Active Control, Multi-National, Multi-Centre, Randomized, Parallel Group Study Assessing Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of CAM2032 q1m (Leuprolide Acetate FluidCrystal® Injection Depot Once Monthly) After Repeat Doses of 3.75 mg and 7.5 mg of Leuprolide Acetate vs. Eligard® 7.5 mg in Patients With Prostate Cancer

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: CAM2032 q1m pharmacokinetic profile (plasma concentration)

Secondary outcome:

CAM2032 q1m effect on serum testosterone (s-T) concentration

CAM2032 q1m effect on serum prostate specific antigen (PSA) levels

Safety of repeat doses of CAM2032 q1m


Minimum age: 40 Years. Maximum age: 85 Years. Gender(s): Male.


Inclusion Criteria:

- Men ≥40 and ≤85 years of age

- Histological or cytological proven adenocarcinoma of the prostate requiring hormone


- 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 Criteria:

- Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction

- S-T 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

- Known hypersensitivity to luteinizing hormone releasing hormone (LHRH) agonists or

other components of CAM2032 q1m or Eligard 7. 5 mg

- Prior orchiectomy, hypophysectomy, or adrenalectomy

- Prior use of LHRH agonists within 12 months prior to the Screening visit and during

the study

Locations and Contacts

Docrates Cancer Center, Helsinki, Finland

University Hospital of Helsinki, Department of urology, Helsinki, Finland

Tampere University Hospital, Department of Urology, Tampere, Finland

University Hospital of Turku, Department of urology, Turku, Finland

National Institute of Oncology Department of Chemotherapy C and Clinical Pharmacology, Budapest, Hungary

Semmelweis University Hospital Department of Urology, Budapest, Hungary

Szent Imre Teaching Hospital, Budapest, Hungary

University of Debrecen, Medical Health Sciences Center, Department of Urology, Debrecen, Hungary

B..A.Z County Teaching Hospital, Institute of Radiotherapy and Clinical Oncology, Miskolc, Hungary

Additional Information

Starting date: September 2014
Last updated: July 3, 2015

Page last updated: August 23, 2015

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