Clinical trial NCT02542501: Study to Evaluate the Presence of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Scheduled to Receive Luteinizing Hormone Releasing Hormone (LHRH) Analogues
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 470
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.


Eligibility criteria: 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

Primary outcomes:
measure: The number of patients having Lower Urinary Tract Symptoms (LUTS) at baseline.
timeFrame: Baseline
measure: 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).
timeFrame: Week 48
Secondary outcomes:
measure: 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.
timeFrame: Week 24
measure: 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.
timeFrame: Week 24
measure: 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).
timeFrame: Week 48
measure: Comparison of the percentage of patients presenting an IPSS ≥ 3 at week 24 to the percentage of patients presenting an IPSS ≥ 3 at baseline.
timeFrame: Week 24
measure: Comparison of the percentage of patients presenting an IPSS ≥ 3 at week 48 to the percentage of patients presenting an IPSS ≥ 3 at baseline.
timeFrame: Week 48
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Hospital Universitário de Coimbra
city: Lisboa
country: Portugal
facility: Hospital de São José
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Matosinhos
country: Portugal
facility: Hospital Pedro Hispano
city: Porto
country: Portugal
facility: Hospital Geral de Santo António
city: Santa Coloma de Gramenet
country: Spain
facility: Hospital Esperit Sant
state: Barcelona
city: Arganda del Rey
country: Spain
facility: Hospital Sureste
state: Madrid
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Badalona
country: Spain
facility: Hospital Germans Trias I Pujol
city: Barcelona
country: Spain
facility: H. del Mar
city: Barcelona
country: Spain
facility: H. Valle Hebrón
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Ciudad Real
country: Spain
facility: Hospital de Ciudad Real
city: Getafe
country: Spain
facility: Hospital Getafe
city: Hospitalet de Llobregat
country: Spain
facility: H. Bellvitge
city: León
country: Spain
facility: Hospital de León
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Univ. La Paz
city: Madrid
country: Spain
facility: Hospital del Sureste, Arganda de Rey
city: Manresa
country: Spain
facility: Hospital Althaia
city: Sabadell
country: Spain
facility: H. Parc Tauli
city: Salamanca
country: Spain
facility: Hospital de Salamanca
city: San Sebastián de los Reyes
country: Spain
facility: Hospital Infanta Sofía
city: San Sebastián
country: Spain
facility: Hospital de Donosti
city: Santa Cruz de Tenerife
country: Spain
facility: H. Univ. Nuestra Señora de la Candelaria
city: Santiago de Compostela
country: Spain
facility: Complejo Clínico Universitario de Santiago
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
city: Vic
country: Spain
facility: Hospital Universitari de Vic
city: Vigo
country: Spain
facility: H. Do Meixoeiro
city: Vitoria
country: Spain
facility: Hospital Santiago Apóstol
city: Vitoria
country: Spain
facility: Hospital de Txagorritxu
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: