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

Abbott

Status: Completed

Conditions: Lower Urinary Tract Symptoms; Advanced Prostate Cancer

Treatments: Drug: Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01078545

P10-612

Details and patient eligibility

About

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.

Full description

The remaining target is:

• to assess the intensity of LUTS in Polish and Ukrainian patients with locally advanced and metastatic prostate cancer, previously untreated with hormonal therapy

Enrollment: 729 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

729 participants in 1 patient group

Adv. PCa patients with LUTS treated with GnRH analogue

Description:

Patients with advanced prostate cancer and lower urinary tract symptoms treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)

Treatment:

Drug: Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)