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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT00751790
First received: September 11, 2008
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasm
Drug: triptorelin embonate (INN)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Debiopharm International SA:

Primary Outcome Measures:
  • Achievement of Castration and Maintenance of Castration [ Time Frame: at Day 29 ] [ Designated as safety issue: No ]
    Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).


Secondary Outcome Measures:
  • LH Increase [ Time Frame: day 1 and day 169 ] [ Designated as safety issue: No ]
    % of patients showing ≤1.0 IU/L increase in s-LH from 0 to 2 h after 1st & 2nd injection.% changes in PSA throughout treatment.% of 60 pts with s-testosterone levels >1.735 nmol/L after 2nd injection.Testosterone PD and triptorelin PK metrics in 15 pts


Enrollment: 120
Study Start Date: July 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triptorelin Drug: triptorelin embonate (INN)
Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks

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 pharmacokinetics and testosterone pharmacodynamics were assessed in a subset of 15 patients.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751790

Locations
South Africa
Quintiles South Africa
Lyttelton Manor, Centurion, South Africa, 0157
Sponsors and Collaborators
Debiopharm International SA
  More Information

No publications provided by Debiopharm International SA

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT00751790     History of Changes
Other Study ID Numbers: DEB-TRI6M-301
Study First Received: September 11, 2008
Results First Received: December 21, 2009
Last Updated: August 30, 2012
Health Authority: South Africa: Medicines Control Council
United States: Food and Drug Administration

Keywords provided by Debiopharm International SA:
triptorelin, 6-month formulation, advanced prostate cancer

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Triptorelin
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014