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

This study has been completed.
Sponsor:
Collaborators:
Fraktal.com.pl
Med-net.pl
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01078545
First received: February 28, 2010
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Advanced Prostate Cancer
Lower Urinary Tract Symptoms
 Drug: Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms. International, Multicenter Post-marketing Observational Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35. [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.


Secondary Outcome Measures:
  • The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. [ Time Frame: Baseline to 3, 6, 9, and 12 months. ] [ Designated as safety issue: No ]
    The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.

  • Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Percentage of participants at baseline with one of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.

  • Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. [ Time Frame: Baseline to 3, 6, 9, and 12 months. ] [ Designated as safety issue: No ]
    Changes in the intensity of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.

  • Reported Adverse Events/Serious Adverse Events [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: Yes ]
    Adverse events (AEs) were collected during the course of the study from the first visit (Baseline) through the last visit (12 months). The number of participants experiencing a non-serious or serious adverse event or both types of events are summarized. See the Reported Adverse Event section for details.


Enrollment: 729
Study Start Date: September 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adv. PCa patients with LUTS treated with GnRH analogue
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)
 Drug: Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)
Leuprolide acetate 11.25 mg every 3 months sc or im, number of injections during the trial - 5 in Poland, Leuprolide acetate 3.75 mg every 1 month sc or im, number of injections during the trial - 12 in Ukraine.
Other Names:
  • Lupron Depot/Leuprolide acetate 11.25 mg
  • Lucrin Depot 11.25 mg
  • Lupron Depot/Leuprolide acetate 3.75 mg
  • Lucrin Depot 3.75 mg

Detailed 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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078545

  Show 143 Study Locations
Sponsors and Collaborators
Abbott
Fraktal.com.pl
Med-net.pl
Investigators
Study Director: Jozef Haczynski, MD, PhD Abbott Laboratories, Poland
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01078545     History of Changes
Other Study ID Numbers: P10-612
Study First Received: February 28, 2010
Results First Received: November 29, 2011
Last Updated: January 12, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Ukraine: Ministry of Health

Keywords provided by Abbott:
Prostate cancer
Lower urinary tract symptoms
Hormonotherapy
LHRH analogue
Androgen deprivation therapy (ADT)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013