| Eligibility |
Inclusion Criteria:
- Be over 18 years of age
- Be able to communicate effectively with the study personnel
- Have histologically confirmed prostate cancer
- Have prostate cancer staged T3-4NxMx or TxN1Mx or TxNxM1 according to the TNM
classification or the patient should have rising PSA after failed local therapy and be
candidate for androgen deprivation therapy
- Have a QTc interval <440 ms
- Subjects are judged by the attending physician and/or Principal Investigator to be a
candidate for androgen deprivation therapy (continuous therapy)
- ECOG performance status of 0 to 2
- Baseline morning serum testosterone levels >150 ng/dL at Screening Visit
- Have a life expectancy of =18 months
- Subjects must agree to use acceptable methods of contraception
1. If their female partners are pregnant or lactating, acceptable methods of
contraception from the time of the first administration of study medication until
6months following administration of the last dose of study medication must be
used. Acceptable methods are: Condom used with spermicidal
foam/gel/film/cream/suppository. If the subject has undergone surgical
sterilization (vasectomy with documentation of azoospermia),a condom with
spermicidal foam/gel/film/cream/suppository should be used.
2. If the male subject's partner could become pregnant, use acceptable methods of
contraception from the time of the first administration of study medication until
6 months following administration of the last dose of study medication.
Acceptable methods of contraception are as follows: Condom with spermicidal
foam/gel/cream/suppository [i.e.,barrier method of contraception], surgical
sterilization (vasectomy with documentation of azoospermia) and a barrier method
{condom used with spermicidal foam/gel/film/cream/suppository}, the female
partner uses oral contraceptives (combination estrogen/progesterone pills),
injectable progesterone or subdermal implants and a barrier method (condom used
with spermicidal foam/gel/film/cream/suppository).
3. If the female partner has undergone documented tubal ligation (female
sterilization), a barrier method (condom used with spermicidal
foam/gel/film/cream/suppository) should also be used.
4. If the female partner has undergone documented placement of an intrauterine
device (IUD) or intrauterine system (IUS),a barrier method (condom with
spermicidal foam/gel/film/cream/suppository) should also be used.
- Laboratory values within the following ranges: hemoglobin =10 gm/dL, total bilirubin
- 1.5x upper limit of normal (ULN), AST =2.5x ULN, ALT =2.5x ULN,
- 1.5 mg/dL, absolute neutrophil count =1500 cell/uL and platelets =100,000
cells/uL.
- Creatinine clearance =60 mL/min based on Cockcroft-Gault equation.
- Subject is willing to comply with the requirements of the protocol through the end of
the study
Exclusion Criteria:
- Prior androgen deprivation therapy within 6 months prior to Screening Visit.
- Potentially curable disease receiving ADT for localized disease
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- Received chemotherapy, cryotherapy, or antiandrogen therapy within 8 weeks prior to
the Screening visit for the treatment of prostate cancer.
- Known hypersensitivity to cetrorelix or other LHRH antagonists
- History of Torsade de Pointes
- Currently taking QT-prolonging drugs
- Any disease or condition (medical or surgical) which might compromise the hematologic,
cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central
nervous system; or other conditions that may interfere with the absorption,
distribution, metabolism or excretion of study drug, or would place the subject at
increased risk
- Use of exogenous testosterone within 6 months of Screening Visit
- Use of 5a-reductase inhibitor within 3 months of Screening Visit
- Use of systemic corticosteroids at a dose >10 mg/day at Screening
- Major surgery within 4 weeks of Screening Visit (including surgery for prostate
cancer)
- Uncontrolled symptomatic congestive heart failure (NYHA Class III -IV), unstable
angina pectoris, cardiac arrhythmia, or uncontrolled atrial fibrillation
- History of diabetes mellitus Type 1. Uncontrolled diabetes mellitus Type 2 (control
with oral hypoglycemic agents are allowed)
- Received an investigational drug within a period of 90days prior to enrollment in the
study
- Received the study medication (VERU-100) previously
- Have been previously diagnosed or treated for active cancer(other than prostate cancer
or non-melanoma skin cancer) within the previous five years
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