A Multicenter, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics and Safety of Two Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer.
- 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
- Signed informed consent before entry into the study.
- 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
- 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
- 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
- Inability to give Informed Consent or to comply fully with the protocol.