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Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

Short name LEMON

NCTNCT01078545 (opens ClinicalTrials.gov in a new tab)Other idP10-612
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
729 participants (actual)
Sponsor
Abbott · Industry
Design
Not stated
Countries
2 countries

Poland, Ukraine

Start
Sept 2008
Primary completion
Nov 2010
Completion
Nov 2010
First posted
2 Mar 2010 (estimated)
Last update posted
16 Jan 2012 (estimated)
Conditions
Advanced Prostate Cancer · Lower Urinary Tract Symptoms

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008200920102011
  1. Ph –

    LEMON

    NCT01078545

    Sept 2008 to Nov 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

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

Arms1

  • Other

    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)

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

    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 outcomes(4)

  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.

    Registry description

    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

    Registry description

    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.

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline to 12 months

The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.

GroupValue (units on a scale)Spread
Advanced PCa Patients With LUTS Treated With GnRH Analogue17.86.9
Secondary and other outcome results(4)
Secondary outcomeMean· Baseline to 3, 6, 9, and 12 months.

The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.

GroupValue (units on a scale)Spread
Advanced PCa Patients With LUTS Treated With GnRH Analogue17.86.9
Secondary outcomeNumber· Baseline

Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.

GroupValue (Percentage of participants)
Advanced PCa Patients With LUTS Treated With GnRH Analogue3
Secondary outcomeMedian· Baseline to 3, 6, 9, and 12 months.

Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.

GroupValue (Units on a scale)
Advanced PCa Patients With LUTS Treated With GnRH Analogue0
Secondary outcomeNumber· Baseline to 12 months

Reported Adverse Events/Serious Adverse Events

GroupValue (Participants)
Advanced PCa Patients With LUTS Treated With GnRH Analogue5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Advanced PCa Patients With LUTS Treated With GnRH AnaloguePatients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)–6 / 7290 / 729

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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