MedDataX Logo

Study to Evaluate the Presence of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Scheduled to Receive Luteinizing Hormone Releasing Hormone (LHRH) Analogues

NCT ID: NCT02542501

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

470 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-07-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The intention of this study is to investigate how many patients with prostate cancer, planned to be treated with LHRH analogues without history of surgery or radiotherapy, are suffering from LUTS. In addition the effect of LHRH analogues on the improvement of theses primary LUTS symptoms over time will be investigated.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult men with locally advanced or metastatic prostate cancer scheduled to receive LHRH analogues. A patient who has completed an IPSS questionnaire in his last visit, before the start of LHRH analogues, will be able to participate in the study. This last visit has to be done 6 months before the baseline visit.
* Patients having provided written informed consent
* Patients mentally fit for completing a self-administered questionnaire

Exclusion Criteria

* Any surgical or radiotherapy treatment performed at prostate level before the entry of the study
* Patient with castrate levels of testosterone ( \< 50 ng/dL) at his first IPSS questionnaire
* Patients who are also participating in any other clinical study within the last 2 months before study entry
* Life expectancy of less than 12 months
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitário de Coimbra

Coimbra, , Portugal

Site Status

Hospital de São José

Lisbon, , Portugal

Site Status

Hospital de Santa Maria

Lisbon, , Portugal

Site Status

Hospital Pedro Hispano

Matosinhos Municipality, , Portugal

Site Status

Hospital Geral de Santo António

Porto, , Portugal

Site Status

Hospital Esperit Sant

Santa Coloma de Gramenet, Barcelona, Spain

Site Status

Hospital Sureste

Arganda, Madrid, Spain

Site Status

Hospital Universitario A Coruña

A Coruña, , Spain

Site Status

Hospital Germans Trias I Pujol

Badalona, , Spain

Site Status

H. del Mar

Barcelona, , Spain

Site Status

H. Valle Hebrón

Barcelona, , Spain

Site Status

Hospital de Basurto

Bilbao, , Spain

Site Status

Hospital de Ciudad Real

Ciudad Real, , Spain

Site Status

Hospital Getafe

Getafe, , Spain

Site Status

H. Bellvitge

L'Hospitalet de Llobregat, , Spain

Site Status

Hospital de León

León, , Spain

Site Status

Hospital de la Princesa

Madrid, , Spain

Site Status

Hospital Univ. La Paz

Madrid, , Spain

Site Status

Hospital del Sureste, Arganda de Rey

Madrid, , Spain

Site Status

Hospital Althaia

Manresa, , Spain

Site Status

H. Parc Tauli

Sabadell, , Spain

Site Status

Hospital de Salamanca

Salamanca, , Spain

Site Status

Hospital de Donosti

San Sebastián, , Spain

Site Status

Hospital Infanta Sofía

San Sebastián de los Reyes, , Spain

Site Status

H. Univ. Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

Complejo Clínico Universitario de Santiago

Santiago de Compostela, , Spain

Site Status

Hospital Joan XXIII

Tarragona, , Spain

Site Status

Hospital Clínico de Valladolid

Valladolid, , Spain

Site Status

Hospital Universitari de Vic

Vic, , Spain

Site Status

H. Do Meixoeiro

Vigo, , Spain

Site Status

Hospital Santiago Apóstol

Vitoria-Gasteiz, , Spain

Site Status

Hospital de Txagorritxu

Vitoria-Gasteiz, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A-ES-52014-219

Identifier Type: -

Identifier Source: org_study_id