Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer

November 21, 2019 updated by: Ipsen

A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of a Subcutaneous Four Months Sustained-release Formulation of Triptorelin, a Gonadotrophin Releasing Hormone Analogue in Patients With Prostate Cancer

To identify the proportion of patients remaining medically castrated (testosterone level < 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Belgium
      • Bruxelles, Belgium, B-1070
        • ULB Erasme
      • Bruxelles, Belgium, B-1090
        • Academisch Ziekenhuis Vrije Universiteit Brussel
      • Bruxelles, Belgium, B-1200
        • UCL St Luc
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, B-3000
        • Uz Gasthuisberg
  • France
      • Clermont Ferrand, France, 63003
        • CHU Hopital Gabriel Montpied
      • Lille, France, 59037
        • Hopital Claude Huriez
      • Lyon, France, 69437
        • Hôpital Edouard Herriot
      • Marseille, France, 13274
        • CHU Hôpital Salvator
      • Nantes Cedex 1, France, 44093
        • Hotel Dieu
      • Paris Cedex 05, France, 75230
        • Hôpital du Val de Grâce
      • Paris Cedex 10, France, 75475
        • Centre Hospitalier Saint Louis
      • Paris Cedex 18, France, 75788
        • Hôpital Bichat
      • Paris cedex 14, France, 75679
        • Hopital Cochin
      • Poitiers, France, 86000
        • CHU Hôpital de la Milétrie
      • Rennes Cedex 9, France, 35033
        • Hopital Pontchaillou
      • Toulouse Cedex 9, France, 31059
        • CHU Rangueil
  • Latvia
      • Daugavpils, Latvia
        • Olega Hublarova arsta prakse urologija
      • Riga, Latvia
        • Latvijas Onkologijas centre
      • Riga, Latvia
        • Paula Stradiņa klīniskā universitates slimnīca
  • Lithuania
      • Kaunas, Lithuania
        • Kauno Medicinos Universitteto Klinikos
      • Vilnius, Lithuania
        • UAB 'Vilniaus onkourologijos-ginekologijos klinika
      • Vilnius, Lithuania
        • Vilniaus Universiteto
  • Poland
      • Kielce, Poland
        • Swietokrzyskie Centrum Onkologii
      • Kutno, Poland
        • NZOZ Specjalista Sp, z.o.o.
      • Warszawa, Poland
        • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
      • Wroclaw, Poland
        • Akademicki Szpital Kliniczny
  • Spain
      • Madrid, Spain
        • Hospital Gregorio Marañón
  • Ukraine
      • Ivano-Frankivsk, Ukraine
        • Ivano Frankovsk State Medical University
      • Kiev, Ukraine
        • Scientific Research Institute of Urology
  • United Kingdom
      • Aberdeen, United Kingdom
        • Aberdeen Royal Infirmary

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient
  • Patient must be 18 years old or over
  • Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy
  • Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment

Exclusion Criteria:

  • Patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy)
  • Patient who underwent a previous surgical castration
  • Prostate cancer therapy within 2 months of baseline visit
  • Patient with testosterone level below 150 ng/dL at screening

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
Time Frame: Day 240
Day 240

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
Time Frame: Day 120
Day 120
Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL.
Time Frame: Day 120 and 240
Day 120 and 240
Time to achieve castration in days post treatment (Tlag)
Time Frame: Day 35
Day 35
Time to escape from castration (Texit)
Time Frame: Prior 4 months
Prior 4 months
Tlag and Texit confirmed by two consecutive measurements taken 1 week apart.
Duration of castration in days (Tcast) Changes in PSA levels.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ipsen

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2-55-52014-145
  • 2006-001511-30 (EudraCT Number)

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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