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

NCT03261999 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: FP01C-17-0012017-001333-88
• Study Type: interventional
• Target: 144
• Locations: 5 countries
• Sites: 21

Brief Summary

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.

Conditions

Prostatic Neoplasms

Keywords

Prostate Neoplasm Cancer Carcinoma

Outcome Measures

Primary Outcomes (1)

• Efficacy of Leuprolide Mesylate (LMIS 25mg)

  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 Outcomes (1)

• Number of Participants With Adverse Events

  168 days

Study Arms (1)

Leuprolide Mesylate 25mg

EXPERIMENTAL

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

Interventions

Leuprolide Mesylate DRUG

Subcutaneous injection of 25mg Leuprolide Mesylate

Leuprolide Mesylate 25mg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foresee Pharmaceuticals Co., Ltd.: lead

Study Sites (21)

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

Location

Arizona Institute of Urology

Tucson, Arizona, 85704, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Carolina Clinical Trials, LLC

Concord, North Carolina, 28025, United States

Location

Urology San Antonio, P.A

San Antonio, Texas, 78229, United States

Location

Urology of Virginia, PLLC

Virginia Beach, Virginia, 23462, United States

Location

Fakultní nemocnice Hradec Králové, Urologická klinika

Hradec Králové, 500 05, Czechia

Location

Uromedical Center Olomouc

Olomouc, 779 00, Czechia

Location

Thomayerova nemocnice, Urologické oddělení

Prague, 140 59, Czechia

Location

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, 50009, Lithuania

Location

Klaipėda University Hospital

Klaipėda, 92288, Lithuania

Location

National Cancer Institute

Vilnius, 08660, Lithuania

Location

Vilnius University Hospital, Santaros klinikos

Vilnius, 08661, Lithuania

Location

UROCENTRUM MILAB, s.r.o.

Prešov, 080 01, Slovakia

Location

Fakultná nemocnica s poliklinikou Žilina Urológia

Žilina, 012 07, Slovakia

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

National Cancer Center

Gyeonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hosptal

Gyeonggi-do, 13620, South Korea

Location

Hallym University Sacred Heart Hospital

Gyeonggi-do, 14068, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: John Mao
• Organization: Foresee Pharmaceuticals Co., Ltd

john.mao@foreseepharma.com

+886 2-7750-0188

Study Officials

• John Mao, PhD

  Foresee Pharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2017
• First Posted: August 25, 2017
• Study Start: September 26, 2017
• Primary Completion: November 19, 2018
• Study Completion: February 1, 2019
• Last Updated: May 4, 2020
• Results First Posted: May 4, 2020

Record last verified: 2019-02

Locations

SL (2); CZ (3); KR (6); US (6); LI (4)