To Evaluate the Criteria for Renewal of Luteinizing Hormone-Releasing Hormone (LHRH) Analogue Treatment in Prostate Cancer Patients (ANAREN)

June 23, 2021 updated by: Ipsen

A Prospective Post Marketing Non Interventional Study to Evaluate the Criteria on Which Renewal of LHRH Analogue Treatment is Made in Patients With Prostate Cancer Locally Advanced or Metastatic.

The purpose of the study, is to determine the percentage of patients for whom the initial LHRH prescription has been renewed

Study Overview

Status

Status

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

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.
Observational

Enrollment (Actual)

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.
510

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

  • Spain
      • A Coruña, Spain, 15006
        • Hospital A Coruña
      • Arganda, Spain, 28500
        • Hospital del Sureste
      • Avilés, Spain, 33401
        • Hospital San Agustín
      • Barakaldo, Spain, 48902
        • Hospital de Txagorritxu
      • Bilbao, Spain, 48902
        • Hospital de Basurto
      • Cartagena, Spain, 30202
        • Hospital Gral. Univ. Santa Lucía
      • Ferrol, Spain, 15405
        • Hospital Arquitecto Marcide
      • Getafe, Spain, 28905
        • Hospital Univ. de Getafe
      • Gijón, Spain, 33394
        • Hospital de Cabueñes
      • Las Palmas De Gran Canaria, Spain, 35010
        • Hospital Universitario Dr Negrin
      • León, Spain, 37007
        • Hospital de Leon
      • Madrid, Spain, 28006
        • Hospital de La Princesa
      • Madrid, Spain, 28046
        • Hospital Univ. La Paz
      • Madrid, Spain, 28703
        • Hospital Univ. Infanta Sofía
      • Madrid, Spain, 28850
        • Hospital de Torrejón
      • Madrid, Spain, 28933
        • Hospital Rey Juan Carlos
      • Miranda de Ebro, Spain, 34004
        • Hospital Comarcal Santiago Apóstol
      • Murcia, Spain, 30120
        • Hospital Uni. Virgen de la Arrixaca
      • Ourense, Spain, 36312
        • Hospital Ntra. Señora del Cristal
      • Palma, Spain, 08003
        • Hospital Son Llatzer
      • Pamplona, Spain, 31008
        • Hospital Virgen del Camino
      • Pontevedra, Spain, 36312
        • Hospital De Montecelo
      • Salamanca, Spain, 37007
        • Hospital Univ. de Salamanca
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico de Santiago
      • Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Valladolid, Spain, 47005
        • Hospital Clínico de Valladolid
      • Vigo, Spain, 36312
        • Hospital Álvaro Cunqueiro

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

Sampling Method

Non-Probability Sample

Study Population

Patients with Prostate cancer locally advanced or metastatic

Description

Inclusion Criteria:

  • Adult men diagnosed of locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy with a 3 or 6 month LHRH analogue including those requiring neo-adjuvant or adjuvant androgen deprivation therapy in association with radiotherapy
  • Patients having provided written informed consent
  • Patients mentally fit for completing a self-administrated questionnaire

Exclusion Criteria:

  • Patients participating in another clinical study at the time of inclusion
  • Patients with another severe malignant disease
  • Life expectancy of less than 12 months
  • Patients already treated with a LHRH analogue within the last year

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

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
Percentage of patients for whom the initial LHRH prescription (the prescription at the baseline visit) has been renewed at first follow-up visit (same type, same formulation).
Time Frame: First follow-up visit (occurs 3 to 6 months from baseline)
First follow-up visit (occurs 3 to 6 months from baseline)

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
Measure Description
Time Frame
Percentage of patients for whom the initial LHRH prescription has been renewed at each visit.
Time Frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Percentage of patients having switched from a 3 months to a 6 months and also 6 months to 3 months formulation at each visit.
Time Frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Percentage of patients starting a 6-month formulation at baseline.
Time Frame: Baseline
The decision to prescribe a LHRH analogue as a 3- or 6-months formulation will be made prior to and independently from the decision to enroll the subject. This decision should be made in accordance with the usual medical practice of the concerned investigator.
Baseline
Reasons leading to a switch from a 3 months to a 6 months formulation (patient) presented as proportion of patients
Time Frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Reasons leading to a switch from a 3 months to a 6 months formulation (physician) presented as proportion of physicians
Time Frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status.
Time Frame: Baseline
Baseline
Change of the Quality of Life Questionnaire QLQ-PR25 score compared to baseline and each visit.
Time Frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Correlation between physician and patient satisfaction and the evolution of the biological parameters (Prostate-specific antigen)
Time Frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Percentage of patients for which the initial prescription (the prescription at the baseline visit) of a LHRH analogue (3 or 6 months) has been stopped and later on renewed (intermittent treatment)
Time Frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Baseline, between 3 to 6 months, 12 months, 18 months and 24 months

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 (ACTUAL)

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.
July 13, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2021

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.
June 14, 2021

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 30, 2016

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.
January 9, 2017

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.
January 11, 2017

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.
June 24, 2021

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.
June 23, 2021

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.
June 1, 2021

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.
  • A-ES-52014-224

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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