A Multicentre, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer
- Histologically or cytologically proven prostate cancer.
- Prostate cancer stage T3-4NxMx, TxN1Mx or TxNxM1 according to the TNM classification
(see Appendix A: 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 (see Appendix B: Karnofsky Performance Scale).
- 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 x upper limit of normal (ULN),
aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) > 3 x ULN).
- 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, progesterone, and anti-androgens.
- Use of systemic or inhaled corticosteroids (topical application permitted).
- Inability to give informed consent or to comply fully with the protocol.