Clinical trial NCT02212197: Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
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 (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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
leuprolide
Lead sponsor: Camurus AB
Sponsor class: INDUSTRY
First posted: 2014-08-08
Enrollment: 51
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 acetate administered subcutaneously once monthly during 3 months.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3
timeFrame: 84 days
measure: Apparent Terminal Half-life (t½) for Dose 1 and Dose 3
timeFrame: Days 0-28 and Days 56-84
measure: Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3
timeFrame: Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)
Secondary outcomes:
measure: Time (Days) to Testosterone Recovery After Dose 3
timeFrame: Days 56-126
measure: Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)
timeFrame: Days 0-126
measure: Mean Prostate Specific Antigen (PSA) Concentration
timeFrame: Days 0-126
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Docrates Cancer Center
city: Helsinki
country: Finland
facility: University Hospital of Helsinki, Department of Urology
city: Tampere
country: Finland
facility: Tampere University Hospital, Department of Urology
city: Turku
country: Finland
facility: University Hospital of Turku, Department of Urology
city: Budapest
country: Hungary
facility: Semmelweis University Hospital Department of Urology
city: Budapest
country: Hungary
facility: Szent Imre Teaching Hospital
city: Debrecen
country: Hungary
facility: University of Debrecen, Medical Health Sciences Center, Department of Urology
Study officials:
affiliation: Tampere University Hospital
name: Teuvo Tammela, Prof
role: PRINCIPAL_INVESTIGATOR
References: