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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: leuprolide acetate; Drug: leuprolide acetate FluidCrystal® injection depot

• Registration Number: NCT02212197
• Lead Sponsor: Camurus AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-08
• Study Start: 2014-09
• Primary Completion: 2015-11
• Study Completion: 2016-03
• Results First Submitted: 2016-12-12
• Results First Submitted QC: 2016-12-12
• Results First Posted: 2017-02-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 51

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eligard 7.5 mg	leuprolide acetate	Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56.
CAM2032 3.75 mg	leuprolide acetate FluidCrystal® injection depot	Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
CAM2032 7.5 mg	leuprolide acetate FluidCrystal® injection depot	Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.

Primary Outcome Measures

Name	Time	Method
Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3	84 days	Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).
Apparent Terminal Half-life (t½) for Dose 1 and Dose 3	Days 0-28 and Days 56-84	Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP.
Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3	Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)	Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.

Secondary Outcome Measures

Name	Time	Method
Time (Days) to Testosterone Recovery After Dose 3	Days 56-126	The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.
Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)	Days 0-126	The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.
Mean Prostate Specific Antigen (PSA) Concentration	Days 0-126	The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126.

Trial Locations

Locations (7)

Docrates Cancer Center; 🇫🇮 Helsinki, Finland

Semmelweis University Hospital Department of Urology; 🇭🇺 Budapest, Hungary

University Hospital of Helsinki, Department of Urology; 🇫🇮 Helsinki, Finland

Szent Imre Teaching Hospital; 🇭🇺 Budapest, Hungary

Tampere University Hospital, Department of Urology; 🇫🇮 Tampere, Finland

University Hospital of Turku, Department of Urology; 🇫🇮 Turku, Finland

University of Debrecen, Medical Health Sciences Center, Department of Urology; 🇭🇺 Debrecen, Hungary