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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

Tracking Information
First Submitted Date February 28, 2010
First Posted Date March 2, 2010
Results First Submitted Date November 29, 2011
Results First Posted Date January 6, 2012
Last Update Posted Date January 16, 2012
Study Start Date September 2008
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 29, 2011)
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.
Original Primary Outcome Measures
 (submitted: February 28, 2010)
  • International Prostate Syndrome Score (IPSS) [ Time Frame: 15 months ]
  • Prostate-Specific Antigen (PSA) level [ Time Frame: 15 months ]
  • Digital Rectal Examination [ Time Frame: 15 months ]
Change History Complete list of historical versions of study NCT01078545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 29, 2011)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: February 28, 2010)
  • Occurrence and intensity of other symptoms of prostate cancer [ Time Frame: 15 months ]
  • Previous therapy of prostate cancer and Benign Prostatic Hyperplasia (BPH) [ Time Frame: 15 months ]
  • Reported Adverse Events/Serious Adverse Events [ Time Frame: 15 months ]
  • Reason of stopping the treatment with Lucrin Depot [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
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.
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary care clinic
Condition
  • Advanced Prostate Cancer
  • Lower Urinary Tract Symptoms
Intervention 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
Study Groups/Cohorts 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)
Intervention: Drug: Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 28, 2010)
729
Original Actual Enrollment Same as current
Actual Study Completion Date November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number NCT01078545
Other Study ID Numbers P10-612
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abbott
Study Sponsor Abbott
Collaborators
  • Fraktal.com.pl
  • Med-net.pl
Investigators
Study Director: Jozef Haczynski, MD, PhD Abbott Laboratories, Poland
PRS Account Abbott
Verification Date January 2012