- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00751790
Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer
July 17, 2014 updated by: Debiopharm International SA
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Centurion
-
Lyttelton Manor, Centurion, South Africa, 0157
- Quintiles South Africa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Triptorelin
|
Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Achievement of Castration and Maintenance of Castration
Time Frame: at Day 29
|
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).
|
at Day 29
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LH Increase
Time Frame: day 1 and day 169
|
% 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
|
day 1 and day 169
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (ACTUAL)
August 1, 2007
Study Completion (ACTUAL)
August 1, 2007
Study Registration Dates
First Submitted
September 11, 2008
First Submitted That Met QC Criteria
September 11, 2008
First Posted (ESTIMATE)
September 12, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
July 25, 2014
Last Update Submitted That Met QC Criteria
July 17, 2014
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Luteolytic Agents
- Triptorelin Pamoate
Other Study ID Numbers
- DEB-TRI6M-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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