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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Debiopharm International SA
• Treatments: Triptorelin Pamoate

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.