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

NCT02542501 | Completed

• 1 other identifier: A-ES-52014-219
• Study Type: observational
• Target: 470
• Locations: 2 countries
• Sites: 32

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• The number of patients having Lower Urinary Tract Symptoms (LUTS) at baseline.

  Baseline

• The percentage of patients suffering from prostate cancer with moderate to severe LUTS (International prostate symptom score (IPSS) >7) at baseline and having at least 3 points reduction of IPSS score at the end of study (48 weeks).

  Week 48

Secondary Outcomes (5)

• The percentage of patients suffering from prostate cancer with moderate to severe LUTS (score IPSS > 7) at baseline and having at least 3 points reduction of IPSS score at week 24.

  Week 24

• The correlation between IPSS score changes and total prostatic-specific antigen (PSA) changes after 24 weeks of treatment compared to baseline in patients with non-operable prostate cancer presenting moderate to severe LUTS (score IPSS >7) at baseline.

  Week 24

• The correlation between IPSS score changes and total PSA changes after 48 weeks of treatment compared to baseline in patients with non-operable prostate cancer presenting moderate to severe LUTS (score IPSS >7).

  Week 48

• Comparison of the percentage of patients presenting an IPSS ≥ 3 at week 24 to the percentage of patients presenting an IPSS ≥ 3 at baseline.

  Week 24

• Comparison of the percentage of patients presenting an IPSS ≥ 3 at week 48 to the percentage of patients presenting an IPSS ≥ 3 at baseline.

  Week 48

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (32)

Hospital Universitário de Coimbra

Coimbra, 3000-075, Portugal

Location

Hospital de São José

Lisbon, 1150-199, Portugal

Location

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Hospital Pedro Hispano

Matosinhos Municipality, 4454-509, Portugal

Location

Hospital Geral de Santo António

Porto, 4099-001, Portugal

Location

Hospital Esperit Sant

Santa Coloma de Gramenet, Barcelona, 08923, Spain

Location

Hospital Sureste

Arganda, Madrid, 28500, Spain

Location

Hospital Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Germans Trias I Pujol

Badalona, 08916, Spain

Location

H. del Mar

Barcelona, 08003, Spain

Location

H. Valle Hebrón

Barcelona, 08035, Spain

Location

Hospital de Basurto

Bilbao, 48013, Spain

Location

Hospital de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Getafe

Getafe, 28905, Spain

Location

H. Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital de León

León, 24008, Spain

Location

Hospital de la Princesa

Madrid, 28006, Spain

Location

Hospital Univ. La Paz

Madrid, 28046, Spain

Location

Hospital del Sureste, Arganda de Rey

Madrid, 28500, Spain

Location

Hospital Althaia

Manresa, 08243, Spain

Location

H. Parc Tauli

Sabadell, 08208, Spain

Location

Hospital de Salamanca

Salamanca, 37007, Spain

Location

Hospital de Donosti

San Sebastián, 20014, Spain

Location

Hospital Infanta Sofía

San Sebastián de los Reyes, 28702, Spain

Location

H. Univ. Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Complejo Clínico Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Joan XXIII

Tarragona, 430005, Spain

Location

Hospital Clínico de Valladolid

Valladolid, 47003, Spain

Location

Hospital Universitari de Vic

Vic, 08500, Spain

Location

H. Do Meixoeiro

Vigo, 36200, Spain

Location

Hospital Santiago Apóstol

Vitoria-Gasteiz, 01004, Spain

Location

Hospital de Txagorritxu

Vitoria-Gasteiz, 01009, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: September 7, 2015
• Study Start: July 1, 2015
• Primary Completion: July 21, 2018
• Study Completion: July 21, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

PT (5); ES (27)