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

Ipsen

Status: Completed

Conditions: Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02542501

A-ES-52014-219

Details and patient eligibility

About

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.

Enrollment: 470 patients

Sex: Male

Volunteers: No 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