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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)

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.

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

Jozef Haczynski, MD, PhD

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.

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

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

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 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 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 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.

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.

Fraktal.com.pl

Med-net.pl

Abbott

The adverse event population includes all enrolled participants.

Patients 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)

Advanced PCa Patients With LUTS Treated With GnRH Analogue

Age Continuous

Sex: Female, Male

Poland

Ukraine

Region of Enrollment

Age of participant when diagnosed with prostate cancer. Results based on 724 participants.

Age at diagnosis of prostate cancer

The mean prostate-specific antigen (PSA) concentration at Baseline. Results based on 718 participants.

Prostate-Specific Antigen (PSA) concentration

Locally advanced

Advanced with metastases

Localized

Lack of data

Prostate cancer type

The Gleason score classifies each participant's prostate cancer based on how the cells look under the microscope. Prostate cancers often have areas with different grades, so a grade is assigned to the 2 areas that make up most of the cancer. The Gleason score is the sum of these 2 grades, resulting in a number from 2 to 10. The higher the Gleason score the more likely it is that the cancer will grow faster and spread beyond the prostate.

Gleason score

Global Medical Services

IPSS at Baseline (n=727)

IPSS at 12 months (n=699)

Analysis conducted in the intent-to-treat population.

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

IPSS at month 3 (n=724)

IPSS at month 6 (n=717)

IPSS at month 9 (n=702)

IPSS at month 12 (n=699)

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

Hematospermia

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

Lymphatic oedema of the lower extremities

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

Hematospermia (Baseline; n=729)

>Month 3 (n=726)

>Month 6 (n=719)

>Month 9 (n=704)

>Month 12 (n=703)

Lower abdominal pain (Baseline; n=729)

Urinary incontinence (Baseline; n=729)

Erectile dysfunction (Baseline; n=729)

Crotch pain (Baseline; n=729)

Anal pain or bleeding (Baseline; n=729)

Lumbar/back pain (Baseline n=729)

Bone pain (Baseline; n=729)

Spinal compression symptoms (Baseline; n=729)

Periph. lymph node enlargement (Baseline; n=729)

Lymphatic oedema, lower extrem. (Baseline; n=729)

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

Spots Global Cancer Trial Database for leuprolide acetate depot susp. 11.25 mg (poland), 3.75 mg (ukraine)