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)

Ipsen32 sites in 2 countries470 target enrollmentJuly 2015

ConditionsProstate Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Ipsen
Enrollment: 470
Locations: 32
Primary Endpoint: 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).
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

July 21, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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).

Time Frame: Week 48

The number of patients having Lower Urinary Tract Symptoms (LUTS) at baseline.

Time Frame: Baseline

Secondary Outcomes

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)
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)
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)
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)