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

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ClinicalTrials.gov Identifier: NCT01078545
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : January 6, 2012
Last Update Posted : January 16, 2012
Sponsor:
Collaborators:
Fraktal.com.pl
Med-net.pl
Information provided by (Responsible Party):
Abbott

Study Description
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Brief 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.

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

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

Study Design
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Study Type : Observational
Actual Enrollment : 729 participants
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.
Study Start Date : September 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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. ]
    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.

  2. Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. [ Time Frame: Baseline ]
    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.

  3. 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. ]
    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.

  4. Reported Adverse Events/Serious Adverse Events [ Time Frame: Baseline to 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078545


Locations
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Sponsors and Collaborators
Abbott
Fraktal.com.pl
Med-net.pl
Investigators
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Study Director: Jozef Haczynski, MD, PhD Abbott Laboratories, Poland
More Information
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01078545    
Other Study ID Numbers: P10-612
First Posted: March 2, 2010    Key Record Dates
Results First Posted: January 6, 2012
Last Update Posted: January 16, 2012
Last Verified: January 2012
Keywords provided by Abbott:
Prostate cancer
Lower urinary tract symptoms
Hormonotherapy
LHRH analogue
Androgen deprivation therapy (ADT)
Additional relevant MeSH terms:
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Prostatic Neoplasms
Lower Urinary Tract Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Urological Manifestations
 Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents