Back to resultsPhase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
leuprolide acetate FluidCrystal® injection depot
leuprolide acetate
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, leuprolide
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
Sites / Locations
- Docrates Cancer Center
- University Hospital of Helsinki, Department of Urology
- Tampere University Hospital, Department of Urology
- University Hospital of Turku, Department of Urology
- Semmelweis University Hospital Department of Urology
- Szent Imre Teaching Hospital
- University of Debrecen, Medical Health Sciences Center, Department of Urology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
CAM2032 3.75 mg
CAM2032 7.5 mg
Eligard 7.5 mg
Arm Description
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56.
Outcomes
Primary Outcome Measures
Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 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, 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
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
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
Time (Days) to Testosterone Recovery After Dose 3
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)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02212197
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Camurus AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, leuprolide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAM2032 3.75 mg
Arm Type
Experimental
Arm Description
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
Arm Title
CAM2032 7.5 mg
Arm Type
Experimental
Arm Description
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
Arm Title
Eligard 7.5 mg
Arm Type
Active Comparator
Arm Description
Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56.
Intervention Type
Drug
Intervention Name(s)
leuprolide acetate FluidCrystal® injection depot
Other Intervention Name(s)
CAM2032
Intervention Type
Drug
Intervention Name(s)
leuprolide acetate
Other Intervention Name(s)
Eligard
Primary Outcome Measure Information:
Title
Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3
Description
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).
Time Frame
84 days
Title
Apparent Terminal Half-life (t½) for Dose 1 and Dose 3
Description
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.
Time Frame
Days 0-28 and Days 56-84
Title
Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3
Description
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.
Time Frame
Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)
Secondary Outcome Measure Information:
Title
Time (Days) to Testosterone Recovery After Dose 3
Description
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.
Time Frame
Days 56-126
Title
Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)
Description
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.
Time Frame
Days 0-126
Title
Mean Prostate Specific Antigen (PSA) Concentration
Description
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.
Time Frame
Days 0-126
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teuvo Tammela, Prof
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Docrates Cancer Center
City
Helsinki
Country
Finland
Facility Name
University Hospital of Helsinki, Department of Urology
City
Helsinki
Country
Finland
Facility Name
Tampere University Hospital, Department of Urology
City
Tampere
Country
Finland
Facility Name
University Hospital of Turku, Department of Urology
City
Turku
Country
Finland
Facility Name
Semmelweis University Hospital Department of Urology
City
Budapest
Country
Hungary
Facility Name
Szent Imre Teaching Hospital
City
Budapest
Country
Hungary
Facility Name
University of Debrecen, Medical Health Sciences Center, Department of Urology
City
Debrecen
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
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