Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of the study is to determine the influence of GnRH (gonadotropin releasing hormone) analogue - Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine) administration on intensity of lower urinary tract symptoms (LUTS) in patients with diagnosed locally advanced and/or metastatic prostate cancer and LUTS.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Collaborators: Fraktal.com.pl; Med-net.pl
• Treatments: Leuprolide

Criteria

Inclusion Criteria:

• Age > 50 years

• Locally advanced (T3-T4) and/or metastatic (N+/M+) hormone-sensitive prostate cancer, confirmed by histological examination

• Presence of lower urinary tract symptoms (LUTS)-IPSS >0

• Treatment with Lucrin® Depot is the routine therapy in the patient. The decision as to Lucrin® Depot choice will not be associated with patient's participation in the study, but will result from the best medical knowledge and practice.

• Until inclusion into PMOS the patient has not been treated with GnRH analogue.

• The patient, before inclusion into the study, has not been treated by surgery (radical prostatectomy).

Exclusion Criteria:

• Patients will not be included into the study if any contraindications to treatment with Lucrin® Depot exist, or if there are other treatment options which, according to the present medical knowledge, are potentially more beneficial for the patient.

• Physician or patient can stop treatment at any moment, if any indications or reasons exist.