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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário de Coimbra | Coimbra | 3000-075 | Portugal | |||
| Hospital de São José |
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Assessed with the Pearson correlation coefficient |
| 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). | Assessed with the Pearson correlation coefficient | 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. | Assessed with the McNemar's test | 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. | Assessed with the McNemar's test | Week 48 |
| Lisbon |
| 1150-199 |
| Portugal |
| Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Hospital Pedro Hispano | Matosinhos Municipality | 4454-509 | Portugal |
| Hospital Geral de Santo António | Porto | 4099-001 | Portugal |
| Hospital Esperit Sant | Santa Coloma de Gramenet | Barcelona | 08923 | Spain |
| Hospital Sureste | Arganda | Madrid | 28500 | Spain |
| Hospital Universitario A Coruña | A Coruña | 15006 | Spain |
| Hospital Germans Trias I Pujol | Badalona | 08916 | Spain |
| H. del Mar | Barcelona | 08003 | Spain |
| H. Valle Hebrón | Barcelona | 08035 | Spain |
| Hospital de Basurto | Bilbao | 48013 | Spain |
| Hospital de Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital Getafe | Getafe | 28905 | Spain |
| H. Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital de León | León | 24008 | Spain |
| Hospital de la Princesa | Madrid | 28006 | Spain |
| Hospital Univ. La Paz | Madrid | 28046 | Spain |
| Hospital del Sureste, Arganda de Rey | Madrid | 28500 | Spain |
| Hospital Althaia | Manresa | 08243 | Spain |
| H. Parc Tauli | Sabadell | 08208 | Spain |
| Hospital de Salamanca | Salamanca | 37007 | Spain |
| Hospital de Donosti | San Sebastián | 20014 | Spain |
| Hospital Infanta Sofía | San Sebastián de los Reyes | 28702 | Spain |
| H. Univ. Nuestra Señora de la Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| Complejo Clínico Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Joan XXIII | Tarragona | 430005 | Spain |
| Hospital Clínico de Valladolid | Valladolid | 47003 | Spain |
| Hospital Universitari de Vic | Vic | 08500 | Spain |
| H. Do Meixoeiro | Vigo | 36200 | Spain |
| Hospital Santiago Apóstol | Vitoria-Gasteiz | 01004 | Spain |
| Hospital de Txagorritxu | Vitoria-Gasteiz | 01009 | Spain |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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