A clinical trial for prostatic cancer patients . The study medication will be Leuprolide Mesylate, which will be administered as an injection twice. Both the study doctors and clinical trial participants know which treatment is being administered, there will be only one treatment group. The safety and efficacy of the medicinal product will be tested during the study.
- Conditions
- Prostate CarcinomaMedDRA version: 20.0Level: LLTClassification code 10036921Term: Prostate carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001333-88-CZ
- Lead Sponsor
- Foresee Pharmaceuticals Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 133
(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
o Absolute neutrophil count = 1,500 cells/µL
o Platelets = 100,000 cells/µL
o Hemoglobin = 10 gm/dL
o Total bilirubin = 1.5 × upper limit of normal (ULN)
o AST (SGOT) = 2.5 × ULN
o ALT (SGPT) = 2.5 × ULN
o Serum creatinine = 1.5 mg/dL
o Lipid profile within acceptable range according to investigator’s opinion
o Serum glucose within acceptable range according to investigator’s opinion
o HbA1c = 9.5%
o Clinical chemistries (K, Na, Mg, Ca and P) within acceptable range according to Investigator’s opinion
o Normal urinalysis results within:
• RBCs = 3 RBCs/hpf
• WBCs = 5 WBCs/hpf
• Nitrate: negative
• Glucose: <0.1 g/dL; but <1.0 g/dL in subjects with diabetes mellitus
(8) Agree to use male contraceptive methods during study trial
(9) In the investigator’s opinion, 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 123
(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 LH-RH suppressive therapy within 6 months of screening visit
(6) Patients who were previously enrolled in the LMIS 50 mg study
(7) Major surgery, including any prostatic surgery, within 4 weeks of screening visit
(8) History and concomitant clinical and radiographic evidence of central nervous system/spinal cord metastases and subjects at risk for spinal cord compression
(9) Clinical evidence of active urinary tract obstruction and subjects at risk for urinary obstruction
(10) History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
(11) History or presence of hypogonadism; or receipt of exogenous testosterone supplementation within 6 months of screening visit
(12) Clinically significant abnormal ECG and/or history of clinically significant cardiovascular disease as judged by the investigator
(13) History of drug and/or alcohol abuse within 6 months of screening visit
(14) Contraindication to leuprolide or an LH-RH agonist as indicated on package labeling
(15) Use of 5-alpha reductase inhibitor within the last 6 months of screening visit
(16) 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.
(17) Use of systemic corticosteroids at a dose > 10 mg/d or anti-androgens
(18) Use of any investigational agent within 4 weeks of screening visit
(19) Use of any over-the-counter (OTC) medication within 4 weeks of screening visit except for those listed in the permitted Concomitant Treatment section
(20) 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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method