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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02542501

Acronym

ANALUTS

Enrollment

470

Registered

2015-09-07

Start date

2015-07-31

Completion date

2018-07-21

Last updated

2018-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Secondary

Measure	Time frame	Description
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 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 48 to the percentage of patients presenting an IPSS ≥ 3 at baseline.	Week 48	Assessed with the McNemar's test
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
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

Countries

Portugal, Spain

Outcome results