Prostatic Neoplasms
Conditions
Keywords
Prostate Neoplasm Cancer Carcinoma
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.
Interventions
Subcutaneous injection of 25mg Leuprolide Mesylate
Sponsors
Foresee Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Leuprolide Mesylate (LMIS 25mg) | 168 days | The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 168 days | Determining the safety and tolerability of LMIS 25 mg based on adverse events (AEs). |
Countries
Czechia, Lithuania, Slovakia, South Korea, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Leuprolide Mesylate 25mg Subjects were 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 were followed until day 168.
Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate | 144 |
| Total | 144 |
Baseline characteristics
| Characteristic | Leuprolide Mesylate 25mg |
|---|---|
| Age, Continuous | 69.8 years STANDARD_DEVIATION 7.93 |
| Diagnosis (days) of prostate carcinoma history | 842.7 days STANDARD_DEVIATION 1348.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 136 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 127 Participants |
| Region of Enrollment Czechia | 9 Participants |
| Region of Enrollment Lithuania | 77 Participants |
| Region of Enrollment Slovakia | 34 Participants |
| Region of Enrollment South Korea | 16 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 144 |
| other Total, other adverse events | 70 / 144 |
| serious Total, serious adverse events | 9 / 144 |
Outcome results
Primary
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.
Time frame: 168 days
Population: ITT (one subject had missing time point at Day 28)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Leuprolide Mesylate 25mg | Efficacy of Leuprolide Mesylate (LMIS 25mg) | 97.9 Percentage of participants |
Secondary
Number of Participants With Adverse Events
Determining the safety and tolerability of LMIS 25 mg based on adverse events (AEs).
Time frame: 168 days
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Mesylate 25mg | Number of Participants With Adverse Events | TEAE | 90 subjects |
| Leuprolide Mesylate 25mg | Number of Participants With Adverse Events | Drug-related TEAE | 53 subjects |
| Leuprolide Mesylate 25mg | Number of Participants With Adverse Events | SAE | 9 subjects |