- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03261999
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
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
Interventional
Enrollment (Actual)
144
Phase
- 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
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Hradec Králové, Czechia, 500 05
- Fakultní nemocnice Hradec Králové, Urologická klinika
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Olomouc, Czechia, 779 00
- Uromedical Center Olomouc
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Praha, Czechia, 140 59
- Thomayerova nemocnice, Urologické oddělení
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Busan, Korea, Republic of, 49241
- Pusan National University Hospital
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Daegu, Korea, Republic of, 41931
- Keimyung University Dongsan Medical Center
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Gyeonggi-do, Korea, Republic of, 10408
- National Cancer Center
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Gyeonggi-do, Korea, Republic of, 14068
- Hallym University Sacred Heart Hospital
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Gyeonggi-do, Korea, Republic of, 13620
- Seoul National University Bundang Hosptal
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Seoul, Korea, Republic of, 02841
- Korea University Anam Hospital
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Kaunas, Lithuania, 50009
- Hospital of Lithuanian University of Health Sciences Kauno Klinikos
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Klaipėda, Lithuania, 92288
- Klaipeda University Hospital
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Vilnius, Lithuania, 08660
- National Cancer Institute
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Vilnius, Lithuania, 08661
- Vilnius University Hospital, Santaros klinikos
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Prešov, Slovakia, 080 01
- UROCENTRUM MILAB, s.r.o.
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Žilina, Slovakia, 012 07
- Fakultná nemocnica s poliklinikou Žilina Urológia
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Alabama
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Homewood, Alabama, United States, 35209
- Urology Centers of Alabama
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Arizona
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Tucson, Arizona, United States, 85704
- Arizona Institute of Urology
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Colorado
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Denver, Colorado, United States, 80211
- The Urology Center of Colorado
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North Carolina
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Concord, North Carolina, United States, 28025
- Carolina Clinical Trials, LLC
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Texas
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San Antonio, Texas, United States, 78229
- Urology San Antonio, P.A
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Virginia
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Virginia Beach, Virginia, United States, 23462
- Urology of Virginia, PLLC
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Males aged ≥ 18 years old
- Males with histologically confirmed carcinoma of the prostate
- Subjects who are judged by the attending physician and/or Principal Investigator to be a candidate for androgen ablation therapy
- Baseline morning serum testosterone level > 150 ng/dL performed at Screening Visit
- Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 2
- Life expectancy of at least 18 months
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
- Agree to use male contraceptive methods during study trial
- 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
- 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 screening visit
- History of blood donation within 2 months of screening visit
- History of anaphylaxis to any LH-RH analogues
- Receipt of any LHRH suppressive therapy within 6 months of screening visit
- Major surgery, including any prostatic surgery, within 4 weeks of screening visit
- History and concomitant clinical and radiographic evidence of central nervous system/spinal cord metastases and subjects at risk for spinal cord compression
- 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 screening visit
- 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.
- Use of systemic corticosteroids at a dose >10 mg/d or anti-androgens
- Use of any investigational agent within 4 weeks of screening visit
- Use of any over-the-counter (OTC) medication within 4 weeks of screening visit 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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. |
Subcutaneous injection of 25mg Leuprolide Mesylate
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Efficacy of Leuprolide Mesylate (LMIS 25mg)
Time Frame: 168 days
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The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168.
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168 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Adverse Events
Time Frame: 168 days
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Determining the safety and tolerability of LMIS 25 mg based on adverse events (AEs).
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168 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
September 26, 2017
Primary Completion (Actual)
November 19, 2018
Study Completion (Actual)
February 1, 2019
Study Registration Dates
First Submitted
August 19, 2017
First Submitted That Met QC Criteria
August 22, 2017
First Posted (Actual)
August 25, 2017
Study Record Updates
Last Update Posted (Actual)
May 4, 2020
Last Update Submitted That Met QC Criteria
April 30, 2020
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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