Status:
COMPLETED
Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer
Lead Sponsor:
Debiopharm International SA
Conditions:
Prostatic Neoplasm
Eligibility:
MALE
Phase:
PHASE3
Brief 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 cast...
Detailed Description
Efficacy of triptorelin treatment on gonadotropin (LH) stimulation from hypophysis, as well as on the PSA (prostate specific antigen) levels and safety laboratory parameters. The triptorelin pharmacok...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00751790
Start Date
July 1 2006
End Date
August 1 2007
Last Update
July 25 2014
Active Locations (1)
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1
Quintiles South Africa
Lyttelton Manor, Centurion, South Africa, 0157