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

NCT02234115 | Completed Phase 3 Results DMC

• 2 other identifiers: FP01C-13-0012013-001790-25
• Study Type: interventional
• Target: 137
• Locations: 8 countries
• Sites: 29

Brief Summary

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.

Conditions

Prostatic Neoplasms

Keywords

Prostate Neoplasm Cancer Carcinoma

Outcome Measures

Primary Outcomes (1)

• Efficacy of Leuprolide Mesylate (LMIS 50mg)

  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 Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  336 days

Study Arms (1)

Leuprolide Mesylate 50mg

EXPERIMENTAL

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

Interventions

Leuprolide Mesylate DRUG

Subcutaneous injection of 50mg Leuprolide Mesylate

Leuprolide Mesylate 50mg

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 judgment

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 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

Sponsors & Collaborators

• Foresee Pharmaceuticals Co., Ltd.: lead

Study Sites (29)

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

Location

Alliance Research Centers

Laguna Hills, California, 92653, United States

Location

Genesis Research, LLC

San Diego, California, 92123, United States

Location

Idaho Urologic Institute - Meridian

Meridian, Idaho, 83642, United States

Location

AdvanceMed Research

Lawrenceville, New Jersey, 08648, United States

Location

Carolina Clinical Trials, LLC

Concord, North Carolina, 28025, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Seattle Urology Research Center

Burien, Washington, 98166, United States

Location

AKH Linz GmbH, Department of Urology

Linz, Upper Austria, 4020, Austria

Location

Universitätsklinik für Urologie und Andrologie, Landeskrankenhaus Salzburg (University hospital for Urology and Andrology)

Salzburg, 5020, Austria

Location

Thomayerova nemocnice Urologické oddělení

Prague, Praha 4 - Krč, 140 59, Czechia

Location

University Hospital Hradec Králové

Hradec Králové, 500 05, Czechia

Location

University Hospital Olomouc

Olomouc, 779 00, Czechia

Location

Universitätsklinikum RWTH Aachen, Klinik für Urologie

Aachen, North Rhine-Westphalia, 52074, Germany

Location

PI Hospital of Lithuanian University of Health Sciences, Kauno Klinikos

Kaunas, 50009, Lithuania

Location

PI Klaipėda University Hospital

Klaipėda, 92288, Lithuania

Location

PI Vilnius University Hospital, Santariškių Klinikos

Vilnius, 08661, Lithuania

Location

Centralny Szpital Kliniczny MSW w Warszawie, Klinika Urologii i Urologii Onkologicznej

Warzawa, Warzawa, 02-507, Poland

Location

Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Układu Moczowego

Warzawa, Warzawa, 02-781, Poland

Location

Uniwersyteckie Centrum Kliniczne, Klinika Urologii

Gdansk, 80-402, Poland

Location

"DERMED" Centrum Medyczne Sp. z o.o.

Lodz, 90-265, Poland

Location

UROCENTRUM MILAB, s.r.o.

Prešov, Slovakia

Location

Fakultná nemocnica s poliklinikou Žilina Urológia

Žilina, 012 07, Slovakia

Location

Kaohsiung Veteran General Hospital (VGHKS)

Kaohsiung City, Pingtung, 813, Taiwan

Location

China Medical University Hospital (CMUH)

Taichung, Taichung, 404, Taiwan

Location

Taichung Veteran General Hospital (VGHTC)

Taichung, Taichung, 407, Taiwan

Location

National Cheng Kung University Hospital (NCKUH)

Tainan, Tainan, 704, Taiwan

Location

National Taiwan University Hospital (NTUH)

Taipei City, Taipei, 100, Taiwan

Location

Chang Gung Memorial Hospital, LinKou (CGMH-LK)

Taoyuan, 333, Taiwan

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: Dr. John Mao
• Organization: Foresee Pharmaceuticals co., Ltd.

john.mao@foreseepharma.com

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: September 1, 2014
• First Posted: September 9, 2014
• Study Start: August 1, 2014
• Primary Completion: August 30, 2016
• Study Completion: January 5, 2017
• Last Updated: March 5, 2019
• Results First Posted: April 13, 2018

Record last verified: 2019-02

Locations

DE (1); PL (4); CZ (3); US (8); AU (2); LI (3); SL (2); TW (6)