Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer

A 12 week (84 day) single injection study in 12 patients with carcinoma of the prostate.

During the screening phase, all patients will come to the clinic for a screening visit (V1), during which the patient's eligibility will be evaluated and baseline assessments will be performed. Eligible patients will sign the informed consent form at this visit.

Within 2 weeks after the screening visit, eligible patients will receive a subcutaneous injection of Pepti 10.8mg on day 0 (V2) and samples will be collected for goserelin 1h, 1.5h, 2h and 3h after the injection. Monitoring of the effects for approximate 4h after the injection will be performed.

Thereafter, patients will return to the clinic for follow-up visits approximately every 2 weeks (Visit 3 to 9: Day 7, 21, 35, 49, 63, 77 and 84). The follow-up visits are planned to enable repeated blood sampling designed to evaluate the testosterone response, safety profile and PSA response.

Inclusion criteria

• Be male at least 18 years of age
• Be an ambulatory patient with carcinoma of the prostate (high risk localized or metastatic) documented by available prostate biopsy information, who in the opinion of the treating physician, is a candidate for androgen deprivation therapy
• Have a testosterone level > 1.5ng/mL or >5nmol/L at screening
• Have a life expectancy of at least 1 year
• Have the ability to understand the requirements of the study and is willing to provide written informed consent
• Agree to abide by the study restrictions and return for the required assessments
• only patients who can be discontinued safety from contra-indicated medications discussed in section 7.4 of the protocol can be included in the study

Exclusion criteria

• Have brain metastases
• Have vertebral metastases with evidence of spinal cord compression
• Have renal impairment due to ureteric obstruction or a history of obstructive uropathy
• Have excruciating, sever bone pain due to extensive bone metastases (however, concomitant therapy with either flutamide or bicalutamide is permitted and encouraged during the first month of the study, in the case where mile bone metastasis are present or suspected)
• Undergone orchiectomy, adrenalectomy or hypophysectomy
• Have undergone prostatic surgical procedures (e.g. radical prostatectomy, transurethral resection of the prostate) within the last month
• Have undergone localized external beam radiotherapy, brachytherapy, thermotherapy or cryotherapy within the last 4 weeks
• Undergone systemic chemotherapy, immunotherapy (e.g. antibody therapies, tumor-vaccines) or biological response modifiers (e.g. cytokines) within the last 3 months
• Have been treated with 5-alpha-reductase inhibitors (e.g finasteride (Proscar®, Propecia®), dutasteride (Avodart®)) within the last month
• Have been previously treated with luteinizing hormone releasing hormone agonists (LHRHa) (e.g. leuprolide (Lupron®), goserelin (Zoladex®) etc.) except if their testosterone levels are above 5 nmol/L and the patient in a known responder
• Have and ongoing treatment with androgen receptor (AR) blockers (e.g. megestrol (Megace®) or cyproterone (Androcur®). Note: Treatment with bicalutamide (Casodex®) IS permitted.
• Have a known hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonists, any Luteinizing Hormone-Releasing Hormone (LHRH) agonists (e.g. leuprolide (Lupron®), goserelin (Zoladex®) etc.) or to the poly(lactic-co-glycolic acid (PLGA)) polymers contained in the study formulation
• Have a liver disease (e.g. cirrhosis, chronic active hepatitis or chronic persistent hepatitis) or has persistent alanine amino-transferase (ALT), aspartate amino-transferase (AST) > 2 X upper limit normal (ULN), serum creatinine > 2 X ULN, serum bilirubin > 2 X ULN
• Have received an investigational drug or participated in a clinical trial within the last 30 days
• Have a clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
• Have a body mass index (BMI) < 18.5
• Be an anticoagulated patient with an International Normalized Ratio (INR) ≥ 2
• Have a history of QT prolongation, congenital long QT syndrome, electrolyte abnormalities, Congestive Heart Failure (CHF), or concurrent administration with QT prolonging drugs or QTc > 450 msec