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

Completed

• 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

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-07
• Primary Completion: 2018-07-21
• Study Completion: 2018-07-21
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 470

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

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 Esperit Sant; 🇪🇸 Santa Coloma de Gramenet, Barcelona, Spain

Hospital Sureste; 🇪🇸 Arganda del Rey, Madrid, Spain

Hospital Universitario A Coruña; 🇪🇸 A Coruña, Spain

Hospital Germans Trias I Pujol; 🇪🇸 Badalona, Spain

H. del Mar; 🇪🇸 Barcelona, Spain

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