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

Prostate Cancer Clinical Trial

— ANALUTS  

Official title:

A Prospective Post Marketing Non Interventional Study to Evaluate the Presence of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Scheduled to Receive LHRH Analogues and to Evaluate the Effect of LHRH Analogues on Lower Urinary Tract Symptoms (ANALUTS Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542501
• Other study ID #: A-ES-52014-219
• Status: Completed
• Start date: July 2015
• Est. completion date: July 21, 2018

Study information

• Verified date: December 2018
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: July 21, 2018
• Est. primary completion date: July 21, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Portugal	Hospital Universitário de Coimbra	Coimbra
Portugal	Hospital de Santa Maria	Lisboa
Portugal	Hospital de São José	Lisboa
Portugal	Hospital Pedro Hispano	Matosinhos
Portugal	Hospital Geral de Santo António	Porto
Spain	Hospital Universitario A Coruña	A Coruña
Spain	Hospital Sureste	Arganda del Rey	Madrid
Spain	Hospital Germans Trias I Pujol	Badalona
Spain	H. del Mar	Barcelona
Spain	H. Valle Hebrón	Barcelona
Spain	Hospital de Basurto	Bilbao
Spain	Hospital de Ciudad Real	Ciudad Real
Spain	Hospital Getafe	Getafe
Spain	H. Bellvitge	Hospitalet de Llobregat
Spain	Hospital de León	León
Spain	Hospital de la Princesa	Madrid
Spain	Hospital del Sureste, Arganda de Rey	Madrid
Spain	Hospital Univ. La Paz	Madrid
Spain	Hospital Althaia	Manresa
Spain	H. Parc Tauli	Sabadell
Spain	Hospital de Salamanca	Salamanca
Spain	Hospital de Donosti	San Sebastián
Spain	Hospital Infanta Sofía	San Sebastián de los Reyes
Spain	Hospital Esperit Sant	Santa Coloma de Gramenet	Barcelona
Spain	H. Univ. Nuestra Señora de la Candelaria	Santa Cruz de Tenerife
Spain	Complejo Clínico Universitario de Santiago	Santiago de Compostela
Spain	Hospital Joan XXIII	Tarragona
Spain	Hospital Clínico de Valladolid	Valladolid
Spain	Hospital Universitari de Vic	Vic
Spain	H. Do Meixoeiro	Vigo
Spain	Hospital de Txagorritxu	Vitoria
Spain	Hospital Santiago Apóstol	Vitoria

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients having Lower Urinary Tract Symptoms (LUTS) at baseline.		Baseline
Primary	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	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
Secondary	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.	Assessed with the Pearson correlation coefficient	Week 24
Secondary	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
Secondary	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
Secondary	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