N/A
N=729
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
Advanced Prostate Cancer · Lower Urinary Tract Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT01078545 ↗Enrolled (actual)
729
Serious AEs
0.8%
Results posted
Jan 2012
Primary outcome: Primary: The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35. — 17.8; 10.0 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine) (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Abbott
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35. |
17.8; 10.0 | — |
| SECONDARY The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. |
17.8; 14.0; 12.3; 10.9; 10.0 | — |
| SECONDARY Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. |
3; 31; 13; 62; 24; 2 | — |
| SECONDARY Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Reported Adverse Events/Serious Adverse Events |
5; 3; 1 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01078545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.