Intervention: RETINOL
Trial phase: Phase 3
ATC code: A11CA01 | D10AD02 | R01AX02 | S01XA02 | V04CB01
SMILES: CC1=C(/C=C/C(C)=C/C=C/C(C)=C/CO)C(C)(C)CCC1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)

LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate
Eligibility criteria:
Inclusion Criteria:

Complete 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001. If a subject wishes to enter the Extension study after more than 28 days following his end of study visit for Protocol FP01C-13-001, his serum testosterone level should be repeated at the screening visit to confirm that his castrate-level testosterone has been maintained.

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)
Aspartate Transaminase (AST/SGOT) ≤ 2.5 × ULN
Alanine Aminotransferase (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
Urinalysis within normal range according to the investigator's judgment
Agree to use male contraceptive methods during study trial
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
All aspects of the protocol explained and written informed consent obtained *If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days prior to entering the Extension study, the Eastern Cooperative Oncology Group (ECOG), Physical Examination (PE), ECG, laboratory and Prostate Specific Antigen (PSA) tests should be repeated.

If the patient has completed 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 within the last 28 days, they will be allowed to enter the Extension study without repeating the testosterone measurements, ECG, PE, laboratory and the PSA tests

Exclusion Criteria:

Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti-androgen therapy other than LMIS 50 mg under Protocol FP01C-13-001 for treatment of carcinoma of the prostate during the subject's participation in Protocol FP01C-13-001. Radiation for pain control will be allowed during the study.
Receipt of any Luteinizing Hormone-releasing Hormone (LHRH) suppressive therapy within 6 months of Screening Visit other than LMIS 50 mg under Protocol FP01C-13-001
Subject has used prohibited treatments as listed in the Section 8.2 during participation in Protocol FP01C-13-001.
Any pathological event, clinical adverse event, or any change in the subject's status at the end of FP01C-13-001 giving indication to the investigator that further participation in the study may not be the best interest of the subject
Investigator considers that it is no longer feasible for the subject to be included in a study of LMIS 50 mg
Subjects with persistent, non-castrate testosterone levels judged by the investigator
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