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Advanced Prostate CancerLEMONNCT01078545

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

An observational study of Advanced Prostate Cancer and Lower Urinary Tract Symptoms, run by Abbott at 143 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, men only
What is being tested?
Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)
Type of treatment
Injection or infusion
How many people
729 participants
Where
143 sitesin 2 countries
Study dates
Sep 2008to Nov 2010
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Primary care clinic

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

143 sites in 2 countries.

143 sites in 2 countries

Poland132 sites

  • Site Reference ID/Investigator# 31076

    Bełchatów, 97-400

  • Site Reference ID/Investigator# 31002

    Bialystok, 11-300

  • Site Reference ID/Investigator# 30977

    Bialystok, 15-027

  • Site Reference ID/Investigator# 31030

    Bialystok, 15-161

  • Site Reference ID/Investigator# 31048

    Bialystok, 15-201

  • Site Reference ID/Investigator# 31083

    Bobrowniki, 42-583

  • Site Reference ID/Investigator# 31028

    Bydgoszcz, 85-209

  • Site Reference ID/Investigator# 31014

    Bytom, 41-902

  • Site Reference ID/Investigator# 31006

    Bytom, 41-908

  • Site Reference ID/Investigator# 31018

    Bytom, 41-933

  • Site Reference ID/Investigator# 31007

    Ciechanów, 06-400

  • Site Reference ID/Investigator# 31004

    Elblag, 82-300

  • Site Reference ID/Investigator# 31090

    Elblag, 82-300

  • Site Reference ID/Investigator# 31044

    Ełk, 19-300

  • Site Reference ID/Investigator# 30994

    Florentynów, 95-083

  • Site Reference ID/Investigator# 9803

    Gdansk, 80-305

  • Site Reference ID/Investigator# 31057

    Gdansk, 80-371

  • Site Reference ID/Investigator# 31101

    Gdansk, 80-462

  • Site Reference ID/Investigator# 31097

    Gdansk, 80-858

  • Site Reference ID/Investigator# 30984

    Gliwice, 44-100

  • Site Reference ID/Investigator# 30976

    Gmina Brwinów, 05-840

  • Site Reference ID/Investigator# 31009

    Gmina Poddębice, 99-200

  • Site Reference ID/Investigator# 31051

    Imielnik Stary, 95-010

  • Site Reference ID/Investigator# 31023

    Inowrocław, 88-100

  • Site Reference ID/Investigator# 31074

    Inowrocław, 88-100

  • Site Reference ID/Investigator# 31032

    Jankowo, 80-180

  • Site Reference ID/Investigator# 31067

    Jarosławiec, 37-500

  • Site Reference ID/Investigator# 30995

    Jastków, 21-002

  • Site Reference ID/Investigator# 31065

    Jastrzębie Zdrój, 44-330

  • Site Reference ID/Investigator# 31031

    Jastrzębie Zdrój, 44-335

  • Site Reference ID/Investigator# 31054

    Jelenia Góra, 58-500

  • Site Reference ID/Investigator# 30997

    Katowice, 40-060

  • Site Reference ID/Investigator# 31036

    Katowice, 40-683

  • Site Reference ID/Investigator# 31055

    Kielce, 25-132

  • Site Reference ID/Investigator# 30999

    Kielce, 25-372

  • Site Reference ID/Investigator# 31102

    Kluczbork, 46-200

  • Site Reference ID/Investigator# 31068

    Kolbudy, 83-83-050

  • Site Reference ID/Investigator# 31020

    Konin, 62-510

  • Site Reference ID/Investigator# 31019

    Krakow, 30-054

  • Site Reference ID/Investigator# 31087

    Krakow, 30-082

  • Site Reference ID/Investigator# 31050

    Krakow, 30-111

  • Site Reference ID/Investigator# 31025

    Krakow, 31-153

  • Site Reference ID/Investigator# 31043

    Krakow, 31-348

  • Site Reference ID/Investigator# 31011

    Krakow, 31-467

  • Site Reference ID/Investigator# 31061

    Krakow, 31-559

  • Site Reference ID/Investigator# 31053

    Krakow

  • Site Reference ID/Investigator# 31029

    Kurów, 24-170

  • Site Reference ID/Investigator# 31010

    Łask, 98-100

  • Site Reference ID/Investigator# 31096

    Łazy, 42-450

  • Site Reference ID/Investigator# 31012

    Legnica, 59-220

  • Site Reference ID/Investigator# 31040

    Leszno, 64-100

  • Site Reference ID/Investigator# 31082

    Lidzbark Warmiński, 11-100

  • Site Reference ID/Investigator# 31086

    Lodz, 91-425

  • Site Reference ID/Investigator# 31052

    Lodz, 91-502

  • Site Reference ID/Investigator# 31047

    Lodz, 91-719

  • Site Reference ID/Investigator# 31089

    Lodz, 93-513

  • Site Reference ID/Investigator# 31060

    Lodz, 93-588

  • Site Reference ID/Investigator# 31039

    Łomża, 18-400

  • Site Reference ID/Investigator# 31049

    Lublin, 20-352

  • Site Reference ID/Investigator# 31100

    Lublin, 20-468

  • Site Reference ID/Investigator# 33278

    Lublin, 20-554

  • Site Reference ID/Investigator# 31103

    Lublin, 20-718

  • Site Reference ID/Investigator# 31104

    Lublin, 20-718

  • Site Reference ID/Investigator# 30998

    Lublin, 20-827

  • Site Reference ID/Investigator# 31056

    Michałowice, 05-816

  • Site Reference ID/Investigator# 31001

    Milcz, 56-300

  • Site Reference ID/Investigator# 31085

    Nysa, 48-300

  • Site Reference ID/Investigator# 30993

    Oborniki Śląskie, 55-120

  • Site Reference ID/Investigator# 30974

    Olsztyn, 10-229

  • Site Reference ID/Investigator# 31080

    Olsztyn, 10-950

  • Site Reference ID/Investigator# 30989

    Opole, 45-002

  • Site Reference ID/Investigator# 30978

    Opole, 45-007

  • Site Reference ID/Investigator# 30982

    Opole, 45-061

  • Site Reference ID/Investigator# 31033

    Opole, 45-367

  • Site Reference ID/Investigator# 31075

    Opole, 45-367

  • Site Reference ID/Investigator# 31042

    Ostrów Wielkopolski, 63-400

  • Site Reference ID/Investigator# 31069

    Piła, 64-920

  • Site Reference ID/Investigator# 31000

    Piotrkow Trybunalski, 97-300

  • Site Reference ID/Investigator# 31013

    Płock, 09-409

  • Site Reference ID/Investigator# 31045

    Poznan, 60-195

  • Site Reference ID/Investigator# 31088

    Poznan, 60-232

  • Site Reference ID/Investigator# 31021

    Poznan, 60-362

  • Site Reference ID/Investigator# 31058

    Poznan, 60-409

  • Site Reference ID/Investigator# 31034

    Poznan, 60-638

  • Site Reference ID/Investigator# 30985

    Poznan, 60-835

  • Site Reference ID/Investigator# 31005

    Puławy, 24-100

  • Site Reference ID/Investigator# 31064

    Puławy, 24-100

  • Site Reference ID/Investigator# 30979

    Puszczykowo, 62-041

  • Site Reference ID/Investigator# 31022

    Pyskowice, 44-120

  • Site Reference ID/Investigator# 31016

    Radlin, 44-310

  • Site Reference ID/Investigator# 31099

    Radom, 26-610

  • Site Reference ID/Investigator# 31041

    Rzeszów, 35-003

  • Site Reference ID/Investigator# 31024

    Siedlce, 08-110

  • Site Reference ID/Investigator# 30988

    Siemianowice Śląskie, 41-106

  • Site Reference ID/Investigator# 31063

    Sieradz, 98-200

  • Site Reference ID/Investigator# 31015

    Sosnowiec, 41-200

  • Site Reference ID/Investigator# 30983

    Starachowice, 27-300

  • Site Reference ID/Investigator# 31084

    Suwałki, 16-400

  • Site Reference ID/Investigator# 31092

    Suwałki, 16-400

  • Site Reference ID/Investigator# 33277

    Suwałki, 16-400

  • Site Reference ID/Investigator# 31008

    Swarzędz, 62-020

  • Site Reference ID/Investigator# 31003

    Świętochłowice, 41-608

  • Site Reference ID/Investigator# 30975

    Szczecin, 70-123

  • Site Reference ID/Investigator# 31046

    Szczecin, 71-050

  • Site Reference ID/Investigator# 30992

    Szczecin, 71-126

  • Site Reference ID/Investigator# 31035

    Szczecin, 71-132

  • Site Reference ID/Investigator# 31071

    Tarnów, 33-100

  • Site Reference ID/Investigator# 31091

    Tarnów, 33-100

  • Site Reference ID/Investigator# 31079

    Tarnowskie Góry, 42-600

  • Site Reference ID/Investigator# 30980

    Tomaszów Mazowiecki, 97-200

  • Site Reference ID/Investigator# 31059

    Torun, 87-100

  • Site Reference ID/Investigator# 30987

    Turek, 62-700

  • Site Reference ID/Investigator# 31066

    Warsaw, 01-636

  • Site Reference ID/Investigator# 31037

    Warsaw, 02-156

  • Site Reference ID/Investigator# 31105

    Warsaw, 02-507

  • Site Reference ID/Investigator# 31106

    Warsaw, 02-507

  • Site Reference ID/Investigator# 31093

    Warsaw, 02-671

  • Site Reference ID/Investigator# 31094

    Warsaw, 02-671

  • Site Reference ID/Investigator# 31095

    Warsaw, 02-671

  • Site Reference ID/Investigator# 31081

    Warsaw, 03-748

  • Site Reference ID/Investigator# 31078

    Warsaw, 05-075

  • Site Reference ID/Investigator# 30986

    Wieliczka, 32-020

  • Site Reference ID/Investigator# 31027

    Wroclaw, 51-318

  • Site Reference ID/Investigator# 31038

    Wroclaw, 51-318

  • Site Reference ID/Investigator# 31062

    Wroclaw, 52-204

  • Site Reference ID/Investigator# 31070

    Wroclaw, 53-008

  • Site Reference ID/Investigator# 31077

    Wroclaw, 53-020

  • Site Reference ID/Investigator# 31072

    Wroclaw, 53-301

  • Site Reference ID/Investigator# 31098

    Zabrze, 41-800

  • Site Reference ID/Investigator# 30996

    Zamość, 22-400

  • Site Reference ID/Investigator# 31073

    Złotniki, 46-061

  • Site Reference ID/Investigator# 30981

    Żory, 44-240

Other trials in Poland

Ukraine11 sites

  • Site Reference ID/Investigator# 31108

    Dnipro, 49017

  • Site Reference ID/Investigator# 31109

    Dnipro, 49017

  • Site Reference ID/Investigator# 31111

    Donetsk, 83000

  • Site Reference ID/Investigator# 31112

    Kharkiv, 61070

  • Site Reference ID/Investigator# 31113

    Kharkiv, 61070

  • Site Reference ID/Investigator# 31114

    Kharkiv, 61070

  • Site Reference ID/Investigator# 31209

    Kiev, 01030

  • Site Reference ID/Investigator# 31110

    Kiev, 03022

  • Site Reference ID/Investigator# 21103

    Kiev, 04107

  • Site Reference ID/Investigator# 31107

    Kiev, 04107

  • Site Reference ID/Investigator# 31115

    Simferopol, 95017

Other trials in Ukraine

About this study

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.

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.

Read the 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
Being tested
Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)
Keywords
Prostate cancer, Lower urinary tract symptoms, Hormonotherapy, LHRH analogue, Androgen deprivation therapy (ADT)
Medical subject headings
Lower Urinary Tract Symptoms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Lupron Depot/Leuprolide acetate 11.25 mg, Lucrin Depot 11.25 mg, Lupron Depot/Leuprolide acetate 3.75 mg, Lucrin Depot 3.75 mg

    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.

Study groups in NCT01078545
Study groupRoleWhat they receive
Adv. PCa patients with LUTS treated with GnRH analoguePatients with advanced prostate cancer and lower urinary tract symptoms treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
Receives: Drug: Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline to 12 months

Secondary outcomes (4)

  1. The Change in the International Prostate Symptom Score (IPSS) From 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.

    Measured: Baseline to 3, 6, 9, and 12 months.

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

    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.

    Measured: Baseline

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

    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.

    Measured: Baseline to 3, 6, 9, and 12 months.

  4. Reported Adverse Events/Serious Adverse Events

    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.

    Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2010 (estimated)
  2. Study startSep 2008
  3. Primary completionNov 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
729 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01078545
Sponsor's protocol ID
P10-612
Acronym
LEMON
Status last verified
Jan 2012
First submitted
28 Feb 2010
Last updated
16 Jan 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Prostate Cancer and Lower Urinary Tract Symptoms, run by Abbott at 143 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in Poland, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01078545.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2012.

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