Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma

February 20, 2019 updated by: Foresee Pharmaceuticals Co., Ltd.

An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma

The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with advanced prostate carcinoma, when administered as two injections six months apart.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multi-center, open-label, single-arm study conducted in 2 parts. Part I was established to provide a vanguard of the first 30 subjects who will have more frequent monitoring of their safety. If safety is established, the remainder of the subjects will be entered into the clinical study (i.e., Part II). All subjects will be males with advanced prostate carcinoma judged to be candidates for medical androgen ablation therapy, and all will receive two injections of LMIS 50 mg six-month apart in an unblinded fashion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Universitätsklinik für Urologie und Andrologie, Landeskrankenhaus Salzburg (University hospital for Urology and Andrology)
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • AKH Linz GmbH, Department of Urology
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • University Hospital Hradec Kralove
      • Olomouc, Czechia, 779 00
        • University Hospital Olomouc
    • Praha 4 - Krč
      • Praha, Praha 4 - Krč, Czechia, 140 59
        • Thomayerova nemocnice Urologické oddělení
  • Germany
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
        • Universitätsklinikum RWTH Aachen, Klinik für Urologie
  • Lithuania
      • Kaunas, Lithuania, 50009
        • PI Hospital of Lithuanian University of Health Sciences, Kauno Klinikos
      • Klaipėda, Lithuania, 92288
        • PI Klaipėda University Hospital
      • Vilnius, Lithuania, 08661
        • PI Vilnius University Hospital, Santariškių Klinikos
  • Poland
      • Gdańsk, Poland, 80-402
        • Uniwersyteckie Centrum Kliniczne, Klinika Urologii
      • Warzawa, Poland, 02-507
        • Centralny Szpital Kliniczny MSW w Warszawie, Klinika Urologii i Urologii Onkologicznej
      • Warzawa, Poland, 02-781
        • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Układu Moczowego
      • Łódź, Poland, 90-265
        • "DERMED" Centrum Medyczne Sp. z o.o.
  • Slovakia
      • Prešov, Slovakia
        • UROCENTRUM MILAB, s.r.o.
      • Žilina, Slovakia, 012 07
        • Fakultná nemocnica s poliklinikou Žilina Urológia
  • Taiwan
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital, LinKou (CGMH-LK)
    • Pingtung
      • Kaohsiung City, Pingtung, Taiwan, 813
        • Kaohsiung Veteran General Hospital (VGHKS)
    • Taichung
      • Taichung City, Taichung, Taiwan, 404
        • China Medical University Hospital (CMUH)
      • Taichung City, Taichung, Taiwan, 407
        • Taichung Veteran General Hospital (VGHTC)
    • Tainan
      • Tainan City, Tainan, Taiwan, 704
        • National Cheng Kung University Hospital (NCKUH)
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • National Taiwan University Hospital (NTUH)
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama
    • California
      • Laguna Hills, California, United States, 92653
        • Alliance Research Centers
      • San Diego, California, United States, 92123
        • Genesis Research, LLC
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Idaho Urologic Institute - Meridian
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • AdvanceMed Research
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • Carolina Clinical Trials, LLC
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Washington
      • Burien, Washington, United States, 98166
        • Seattle Urology Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Males aged ≥ 18 years old
  2. Males with histologically confirmed carcinoma of the prostate
  3. Subjects who are judged by the attending physician and/or Principal Investigator to be a candidate for androgen ablation therapy
  4. Baseline morning serum testosterone level > 150 ng/dL performed at Screening Visit
  5. Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 2
  6. Life expectancy of at least 18 months

  7. Laboratory values

    • Absolute neutrophil count ≥ 1,500 cells/µL
    • Platelets ≥ 100,000 cells/µL
    • Hemoglobin ≥ 10 gm/dL
    • Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
    • AST (SGOT) ≤ 2.5 × ULN
    • ALT (SGPT) ≤ 2.5 × ULN
    • Serum creatinine ≤ 1.5 mg/dL
    • Lipid profile within acceptable range according to investigator's judgment
    • HgbA1c within acceptable range according to investigator's judgment
    • Clinical chemistries (K, Na, Mg, Ca and P) within acceptable range according to investigator's judgment
    • Serum glucose within acceptable range according to investigator's judgement
    • Urinalysis within normal range according to the investigator's judgment
  8. Agree to use male contraceptive methods during study trial
  9. Based on the Investigator's judgment, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol
  10. All aspects of the protocol explained and written informed consent obtained

Exclusion Criteria:

  • Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti- androgen therapy concomitantly, or within 8 weeks prior to Screening Visit, for treatment of carcinoma of the prostate. Radiation for pain control will be allowed during the study.
  • Receipt of any vaccination (including influenza) within 4 weeks of Baseline
  • History of blood donation within 2 months of Baseline
  • History of anaphylaxis to any LH-RH analogues
  • Receipt of any LHRH suppressive therapy within 6 months of Baseline
  • Major surgery, including any prostatic surgery, within 4 weeks of Baseline
  • History and concomitant clinical and radiographic evidence of central nervous system/spinal cord metastases. Subjects at risk for spinal cord compression will be excluded.
  • Clinical evidence of active urinary tract obstruction and subjects at risk for urinary obstruction
  • History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
  • History or presence of hypogonadism, or receipt of exogenous testosterone supplementation within 6 months of Baseline
  • Clinically significant abnormal ECG and/or history of clinically significant cardiovascular disease as judged by the investigator
  • History of drug and/or alcohol abuse within 6 months of Baseline
  • Contraindication to leuprolide or an LHRH agonist as indicated on package labeling
  • Use of 5-alpha reductase inhibitor within the last 6 months of Baseline
  • History or presence of insulin-dependent diabetes mellitus (Type I). Presence of well controlled diabetes mellitus Type II will be allowed
  • Use of systemic corticosteroids at a dose >10 mg/d or anti-androgens
  • Use of any investigational agent within 4 weeks of Baseline
  • Use of any over-the-counter (OTC) medication within 4 weeks of Baseline except for those listed in the permitted Concomitant Treatment section.
  • Uncontrolled intercurrent illness that would jeopardize the subject's safety, interfere with the objectives of the protocol, or limit the subject's compliance with study requirements, as determined by the Investigator in consultation with the Sponsor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Leuprolide Mesylate 50mg
All subjects will be males with advanced prostate carcinoma. They will be injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects will be followed until day 336.
Drug: Leuprolide Mesylate
Subcutaneous injection of 50mg Leuprolide Mesylate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of Leuprolide Mesylate (LMIS 50mg)
Time Frame: baseline to 28 days, 28 days to 336 days
The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).
baseline to 28 days, 28 days to 336 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: 336 days
Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.
336 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foresee Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FP01C-13-001
  • 2013-001790-25 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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