Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer
Condition: Prostatic Neoplasm
MeSH terms: Prostatic Neoplasms
Intervention: triptorelin embonate (INN)
Intervention description: Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Male
Healthy volunteers: No
Keywords: triptorelin, 6-month formulation, advanced prostate cancer

Summary:

      Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate
      cancer. It was assumed that during the study treatment >90% of the patients would achieve and
      maintain castrate levels of serum testosterone.
    

Eligibility criteria:

        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.