Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer

Inclusion Criteria

• Histologically or cytologically proven prostate cancer.
• The prostate cancer should be staged T3-4NxMx or TxN1-3Mx 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.
• Serum testosterone levels >5 nmol/L.
• Karnofsky performance index >40.
• Expected survival > 18 months.
• Absence of another malignancy, other than local dermatological, for the previous 5 years.
• Signed informed consent before entry into the study.

Exclusion Criteria

• Prior hormonal treatment for prostate cancer within 6 months prior to study start.
• Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within 2 months prior to study start.
• Presence of another neoplastic lesion or brain metastases.
• Prior hypophysectomy or adrenalectomy.
• Known or suspicion of vertebral metastases with risk of spinal compression.
• Severe kidney or liver failure (creatinine > 2 times the upper normal limit, ASAT and ALAT >3 times the upper normal limit).
• Any concomitant disorder or resulting therapy that is likely to interfere with patient compliance or with the study in the opinion of the Investigator.
• Participation in another study with an experimental drug within 3 months before study start or within 5 drug half-lives of the investigational drug (whichever is the longer).
• Known hypersensitivity to any of the test materials or related compounds.
• Known active use of recreational drug or alcohol dependence in the opinion of the Investigator.
• Any current use or use within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens, and progesterone.
• Use of systemic or inhaled corticosteroids (topical application permitted).
• Use of anticoagulants: heparin and coumarine derivatives (acetylsalicylic acid permitted).
• Inability to give Informed Consent or to comply fully with the protocol.