Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer

April 30, 2020 updated by: Foresee Pharmaceuticals Co., Ltd.

An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer

The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with prostate cancer, when administered as two injections twelve weeks 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-national, multi-center, open-label, single-arm study. All subjects will be males with prostate cancer judged to be candidates for medical androgen ablation therapy and all will receive two injections of LMIS 25 mg twelve-week 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.
144

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

  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Fakultní nemocnice Hradec Králové, Urologická klinika
      • Olomouc, Czechia, 779 00
        • Uromedical Center Olomouc
      • Praha, Czechia, 140 59
        • Thomayerova nemocnice, Urologické oddělení
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center
      • Gyeonggi-do, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hosptal
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Hospital of Lithuanian University of Health Sciences Kauno klinikos
      • Klaipėda, Lithuania, 92288
        • Klaipeda University Hospital
      • Vilnius, Lithuania, 08660
        • National Cancer Institute
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital, Santaros Klinikos
  • Slovakia
      • Prešov, Slovakia, 080 01
        • UROCENTRUM MILAB, s.r.o.
      • Žilina, Slovakia, 012 07
        • Fakultná nemocnica s poliklinikou Žilina Urológia
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Arizona Institute of Urology
    • Colorado
      • Denver, Colorado, United States, 80211
        • The Urology Center of Colorado
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • Carolina Clinical Trials, LLC
    • Texas
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio, P.A
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia, PLLC

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 opinion
    • Serum glucose within acceptable range according to investigator's opinion
    • HgbA1c within acceptable range according to investigator's opinion
    • 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:

  1. 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.
  2. Receipt of any vaccination (including influenza) within 4 weeks of screening visit
  3. History of blood donation within 2 months of screening visit
  4. History of anaphylaxis to any LH-RH analogues
  5. Receipt of any LHRH suppressive therapy within 6 months of screening visit
  6. Major surgery, including any prostatic surgery, within 4 weeks of screening visit
  7. History and concomitant clinical and radiographic evidence of central nervous system/spinal cord metastases and subjects at risk for spinal cord compression
  8. Clinical evidence of active urinary tract obstruction and subjects at risk for urinary obstruction
  9. History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
  10. History or presence of hypogonadism, or receipt of exogenous testosterone supplementation within 6 months of Baseline
  11. Clinically significant abnormal ECG and/or history of clinically significant cardiovascular disease as judged by the investigator
  12. History of drug and/or alcohol abuse within 6 months of Baseline
  13. Contraindication to leuprolide or an LHRH agonist as indicated on package labeling
  14. Use of 5-alpha reductase inhibitor within the last 6 months of screening visit
  15. History or presence of insulin-dependent diabetes mellitus (Type I). Presence of well controlled diabetes mellitus Type II will be allowed if only oral hypoglycemic are required. Prostate cancer subjects with poor controlled diabetes mellitus with Hb1Ac > 9.5% or urine glycosuria > 1.0 g/dL should be excluded.
  16. Use of systemic corticosteroids at a dose >10 mg/d or anti-androgens
  17. Use of any investigational agent within 4 weeks of screening visit
  18. Use of any over-the-counter (OTC) medication within 4 weeks of screening visit except for those listed in the permitted Concomitant Treatment section.
  19. 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 25mg

All subjects will be males with prostate cancer. They will be injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.

The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects will be followed until day 168.
Drug: Leuprolide Mesylate
Subcutaneous injection of 25mg 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 25mg)
Time Frame: 168 days
The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168.
168 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
Time Frame: 168 days
Determining the safety and tolerability of LMIS 25 mg based on adverse events (AEs).
168 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 (Actual)

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.
September 26, 2017

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.
November 19, 2018

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.
February 1, 2019

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).
August 19, 2017

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.
August 22, 2017

First Posted (Actual)

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.
August 25, 2017

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.
May 4, 2020

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.
April 30, 2020

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-17-001
  • 2017-001333-88 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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