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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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 Cabuenes
      • 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 Alvaro 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

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

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

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

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)

July 13, 2017

Primary Completion (ACTUAL)

June 14, 2021

Study Completion (ACTUAL)

June 14, 2021

Study Registration Dates

First Submitted

December 30, 2016

First Submitted That Met QC Criteria

January 9, 2017

First Posted (ESTIMATE)

January 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 23, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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