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Completed

NCT Number: NCT01078545

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

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.

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Key information

Conditions

Advanced Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urological Manifestations

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Site Reference ID/Investigator# 31076, Bełchatów, Poland

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • Fraktal.com.pl
  • Med-net.pl

Registry information

Official study 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.

Acronym: LEMON

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 2, 2010
Registry last updated
Jan 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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