Study to Evaluate the Presence of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Scheduled to Receive Luteinizing Hormone Releasing Hormone (LHRH) Analogues
- Conditions
- Prostate Cancer
- Registration Number
- NCT02542501
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 470
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 The number of patients having Lower Urinary Tract Symptoms (LUTS) at baseline. Baseline
- Secondary Outcome Measures
Name Time Method 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 Assessed with the Pearson correlation coefficient
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 Assessed with the Pearson correlation coefficient
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 Assessed with the McNemar's test
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 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 Assessed with the McNemar's test
Trial Locations
- Locations (32)
Hospital Universitário de Coimbra
🇵🇹Coimbra, Portugal
Hospital de São José
🇵🇹Lisboa, Portugal
Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Hospital Pedro Hispano
🇵🇹Matosinhos, Portugal
Hospital Geral de Santo António
🇵🇹Porto, Portugal
Hospital Universitario A Coruña
🇪🇸A Coruña, Spain
H. del Mar
🇪🇸Barcelona, Spain
Hospital Germans Trias I Pujol
🇪🇸Badalona, Spain
H. Valle Hebrón
🇪🇸Barcelona, Spain
Hospital de Basurto
🇪🇸Bilbao, Spain
Hospital Getafe
🇪🇸Getafe, Spain
Hospital de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital de León
🇪🇸León, Spain
H. Bellvitge
🇪🇸Hospitalet de Llobregat, Spain
Hospital de la Princesa
🇪🇸Madrid, Spain
Hospital Univ. La Paz
🇪🇸Madrid, Spain
Hospital del Sureste, Arganda de Rey
🇪🇸Madrid, Spain
H. Parc Tauli
🇪🇸Sabadell, Spain
Hospital Althaia
🇪🇸Manresa, Spain
Hospital de Salamanca
🇪🇸Salamanca, Spain
Hospital de Donosti
🇪🇸San Sebastián, Spain
Hospital Infanta Sofía
🇪🇸San Sebastián de los Reyes, Spain
Hospital Clínico de Valladolid
🇪🇸Valladolid, Spain
H. Univ. Nuestra Señora de la Candelaria
🇪🇸Santa Cruz de Tenerife, Spain
Hospital Joan XXIII
🇪🇸Tarragona, Spain
Complejo Clínico Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Universitari de Vic
🇪🇸Vic, Spain
Hospital Santiago Apóstol
🇪🇸Vitoria, Spain
H. Do Meixoeiro
🇪🇸Vigo, Spain
Hospital de Txagorritxu
🇪🇸Vitoria, Spain
Hospital Sureste
🇪🇸Arganda del Rey, Madrid, Spain
Hospital Esperit Sant
🇪🇸Santa Coloma de Gramenet, Barcelona, Spain