Lucrin® Depot Efficacy and Safety Monitoring Study in Pat... | NCT01078545

Status Module

Name	Class
Fraktal.com.pl	UNKNOWN
Med-net.pl	UNKNOWN

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)	Drug: Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline to 12 months

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jozef Haczynski, MD, PhD	Abbott Laboratories, Poland	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 31076		Bełchatów		97-400	Poland
Site Reference ID/Investigator# 31002

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Advanced PCa Patients With LUTS Treated With GnRH Analogue	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)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00071.2± 7.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000
Male	BG000729

Region of Enrollment

Number

participants

Title

Denominators

Categories

Poland

Title	Measurements
	BG000659

Ukraine

Title	Measurements
	BG000

Age at diagnosis of prostate cancer

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

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00070.7± 7.1

Prostate-Specific Antigen (PSA) concentration

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

Mean

Standard Deviation

ng/mL

Title

Denominators

Categories

Title	Measurements
	BG00055.8± 291.5

Prostate cancer type

Number

Participants

Title

Denominators

Categories

Locally advanced

Title	Measurements
	BG000562

Advanced with metastases

Title	Measurements
	BG000

Gleason score

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.

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG0001

Title	Measurements

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Analysis conducted in the intent-to-treat population.

Posted

Mean

Standard Deviation

units on a scale

Baseline to 12 months

ID	Title	Description
OG000	Advanced PCa Patients With LUTS Treated With GnRH Analogue	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)

Units	Counts
Participants	OG000729

Title

Denominators

Categories

IPSS at Baseline (n=727)

Title	Measurements
	OG00017.8± 6.9

IPSS at 12 months (n=699)

Title	Measurements
	OG00010.0± 5.0

Secondary

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

Analysis conducted in the intent-to-treat population.

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	Advanced PCa Patients With LUTS Treated With GnRH Analogue	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)

Units	Counts
Participants	OG000

Secondary

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.

Analysis conducted in the intent-to-treat population.

Posted

Number

Percentage of participants

Baseline

ID	Title	Description
OG000	Advanced PCa Patients With LUTS Treated With GnRH Analogue	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)

Units	Counts
Participants	OG000

Secondary

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.

Analysis conducted in the intent-to-treat population.

Posted

Median

Full Range

Units on a scale

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

ID	Title	Description
OG000	Advanced PCa Patients With LUTS Treated With GnRH Analogue	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)

Units	Counts
Participants	OG000

Secondary

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.

Analysis conducted in the intent-to-treat population.

Posted

Number

Participants

Baseline to 12 months

ID	Title	Description
OG000	Advanced PCa Patients With LUTS Treated With GnRH Analogue	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)

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Advanced PCa Patients With LUTS Treated With GnRH Analogue	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)			6	729	0	729

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Renal failure	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected729 at risk
Blood creatinine increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected729 at risk
Blood urea increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected729 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected729 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected729 at risk
Multi-organ failure	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected729 at risk
Death	General disorders	MedDRA 14.0	Systematic Assessment	EG0003 events3 affected729 at risk
Oedema peripheral	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected729 at risk
Bone pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected729 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected729 at risk
Weight increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected729 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected729 at risk

Ancestor Terms

ID	Term
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D009479	Neuropeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D009842	Oligopeptides
D009419	Nerve Tissue Proteins
D011506	Proteins

ID	Term
D059411	Lower Urinary Tract Symptoms
D011471	Prostatic Neoplasms