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

NCT ID: NCT03261999

Last Updated: 2020-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-26
• Study Completion Date: 2019-02-01

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.

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.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Leuprolide Mesylate

Intervention Type: DRUG

Subcutaneous injection of 25mg Leuprolide Mesylate

Interventions

Leuprolide Mesylate

Subcutaneous injection of 25mg Leuprolide Mesylate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Foresee Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Mao, PhD

Role: STUDY_DIRECTOR

Foresee Pharmaceuticals Co., Ltd.

Locations

Urology Centers of Alabama

Homewood, Alabama, United States

Arizona Institute of Urology

Tucson, Arizona, United States

The Urology Center of Colorado

Denver, Colorado, United States

Carolina Clinical Trials, LLC

Concord, North Carolina, United States

Urology San Antonio, P.A

San Antonio, Texas, United States

Urology of Virginia, PLLC

Virginia Beach, Virginia, United States

Fakultní nemocnice Hradec Králové, Urologická klinika

Hradec Králové, , Czechia

Uromedical Center Olomouc

Olomouc, , Czechia

Thomayerova nemocnice, Urologické oddělení

Prague, , Czechia

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, , Lithuania

Klaipėda University Hospital

Klaipėda, , Lithuania

National Cancer Institute

Vilnius, , Lithuania

Vilnius University Hospital, Santaros klinikos

Vilnius, , Lithuania

UROCENTRUM MILAB, s.r.o.

Prešov, , Slovakia

Fakultná nemocnica s poliklinikou Žilina Urológia

Žilina, , Slovakia

Pusan National University Hospital

Busan, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

National Cancer Center

Gyeonggi-do, , South Korea

Seoul National University Bundang Hosptal

Gyeonggi-do, , South Korea

Hallym University Sacred Heart Hospital

Gyeonggi-do, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Countries

United States; Czechia; Lithuania; Slovakia; South Korea

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-001333-88

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FP01C-17-001

Identifier Type: -

Identifier Source: org_study_id