Clinical trial NCT02234115: Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma
Official title: An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Neoplasms
Keywords: Prostate Neoplasm Cancer Carcinoma
Lead sponsor: Foresee Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-09-09
Enrollment: 137
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This is a multi-center, open-label, single-arm study conducted in 2 parts. Part I was established to provide a vanguard of the first 30 subjects who will have more frequent monitoring of their safety. If safety is established, the remainder of the subjects will be entered into the clinical study (i.e., Part II). All subjects will be males with advanced prostate carcinoma judged to be candidates for medical androgen ablation therapy, and all will receive two injections of LMIS 50 mg six-month apart in an unblinded fashion.

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 judgment
   * HgbA1c within acceptable range according to investigator's judgment
   * 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:

* 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
* Use of systemic corticosteroids at a dose \>10 mg/d or anti-androgens
* Use of any investigational agent within 4 weeks of Baseline
* Use of any over-the-counter (OTC) medication within 4 weeks of Baseline 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

Primary outcomes:
measure: Efficacy of Leuprolide Mesylate (LMIS 50mg)
timeFrame: baseline to 28 days, 28 days to 336 days
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 336 days
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: San Diego
country: United States
facility: Genesis Research, LLC
state: California
city: Meridian
country: United States
facility: Idaho Urologic Institute - Meridian
state: Idaho
city: Lawrenceville
country: United States
facility: AdvanceMed Research
state: New Jersey
city: Concord
country: United States
facility: Carolina Clinical Trials, LLC
state: North Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Burien
country: United States
facility: Seattle Urology Research Center
state: Washington
city: Linz
country: Austria
facility: AKH Linz GmbH, Department of Urology
state: Oberösterreich
city: Salzburg
country: Austria
facility: Universitätsklinik für Urologie und Andrologie, Landeskrankenhaus Salzburg (University hospital for Urology and Andrology)
city: Praha
country: Czechia
facility: Thomayerova nemocnice Urologické oddělení
state: Praha 4 - Krč
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Králové
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Aachen
country: Germany
facility: Universitätsklinikum RWTH Aachen, Klinik für Urologie
state: Nordrhein-Westfalen
city: Kaunas
country: Lithuania
facility: PI Hospital of Lithuanian University of Health Sciences, Kauno Klinikos
city: Klaipėda
country: Lithuania
facility: PI Klaipėda University Hospital
city: Vilnius
country: Lithuania
facility: PI Vilnius University Hospital, Santariškių Klinikos
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Urologii
city: Warzawa
country: Poland
facility: Centralny Szpital Kliniczny MSW w Warszawie, Klinika Urologii i Urologii Onkologicznej
city: Warzawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Układu Moczowego
city: Łódź
country: Poland
facility: "DERMED" Centrum Medyczne Sp. z o.o.
city: Prešov
country: Slovakia
facility: UROCENTRUM MILAB, s.r.o.
city: Žilina
country: Slovakia
facility: Fakultná nemocnica s poliklinikou Žilina Urológia
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veteran General Hospital (VGHKS)
state: Pingtung
city: Taichung City
country: Taiwan
facility: China Medical University Hospital (CMUH)
state: Taichung
city: Taichung City
country: Taiwan
facility: Taichung Veteran General Hospital (VGHTC)
state: Taichung
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital (NCKUH)
state: Tainan
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital (NTUH)
state: Taipei
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, LinKou (CGMH-LK)
Study officials:
affiliation: Foresee Pharmaceuticals Co., Ltd.
name: John Mao, PhD
role: STUDY_DIRECTOR
References: