Trial Outcomes & Findings for Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS) (NCT NCT01078545)
NCT ID: NCT01078545
Last Updated: 2012-01-16
Results Overview
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.
COMPLETED
729 participants
Baseline to 12 months
2012-01-16
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
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Overall Study
STARTED
|
729
|
|
Overall Study
Intent-to-treat Population
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729
|
|
Overall Study
Per Protocol Population
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661
|
|
Overall Study
COMPLETED
|
703
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
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)
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|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
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Overall Study
Physician Decision
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6
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Death
|
3
|
|
Overall Study
Participant moved to another physician
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1
|
Baseline Characteristics
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
Baseline characteristics by cohort
| Measure |
Advanced PCa Patients With LUTS Treated With GnRH Analogue
n=729 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)
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|---|---|
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Age Continuous
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71.2 years
STANDARD_DEVIATION 7.2 • n=5 Participants
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|
Sex: Female, Male
Female
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
729 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
659 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
70 participants
n=5 Participants
|
|
Age at diagnosis of prostate cancer
|
70.7 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Prostate-Specific Antigen (PSA) concentration
|
55.8 ng/mL
STANDARD_DEVIATION 291.5 • n=5 Participants
|
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Prostate cancer type
Locally advanced
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562 Participants
n=5 Participants
|
|
Prostate cancer type
Advanced with metastases
|
127 Participants
n=5 Participants
|
|
Prostate cancer type
Localized
|
39 Participants
n=5 Participants
|
|
Prostate cancer type
Lack of data
|
1 Participants
n=5 Participants
|
|
Gleason score
2
|
1 participants
n=5 Participants
|
|
Gleason score
3
|
3 participants
n=5 Participants
|
|
Gleason score
4
|
35 participants
n=5 Participants
|
|
Gleason score
5
|
53 participants
n=5 Participants
|
|
Gleason score
6
|
151 participants
n=5 Participants
|
|
Gleason score
7
|
262 participants
n=5 Participants
|
|
Gleason score
8
|
167 participants
n=5 Participants
|
|
Gleason score
9
|
41 participants
n=5 Participants
|
|
Gleason score
10
|
13 participants
n=5 Participants
|
|
Gleason score
Lack of data
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: Analysis conducted in the intent-to-treat population.
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.
Outcome measures
| Measure |
Advanced PCa Patients With LUTS Treated With GnRH Analogue
n=729 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)
|
|---|---|
|
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 Baseline (n=727)
|
17.8 units on a scale
Standard Deviation 6.9
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|
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 12 months (n=699)
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10.0 units on a scale
Standard Deviation 5.0
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SECONDARY outcome
Timeframe: Baseline to 3, 6, 9, and 12 months.Population: Analysis conducted in the intent-to-treat population.
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.
Outcome measures
| Measure |
Advanced PCa Patients With LUTS Treated With GnRH Analogue
n=729 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)
|
|---|---|
|
The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.
IPSS at Baseline (n=727)
|
17.8 units on a scale
Standard Deviation 6.9
|
|
The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.
IPSS at month 3 (n=724)
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14.0 units on a scale
Standard Deviation 5.6
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|
The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.
IPSS at month 6 (n=717)
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12.3 units on a scale
Standard Deviation 5.1
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|
The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.
IPSS at month 9 (n=702)
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10.9 units on a scale
Standard Deviation 4.9
|
|
The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.
IPSS at month 12 (n=699)
|
10.0 units on a scale
Standard Deviation 5.0
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SECONDARY outcome
Timeframe: BaselinePopulation: Analysis conducted in the intent-to-treat population.
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.
Outcome measures
| Measure |
Advanced PCa Patients With LUTS Treated With GnRH Analogue
n=729 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)
|
|---|---|
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Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Hematospermia
|
3 Percentage of participants
|
|
Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Lower abdominal pain
|
31 Percentage of participants
|
|
Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Urine incontinence
|
13 Percentage of participants
|
|
Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Erectile dysfunction
|
62 Percentage of participants
|
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Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Crotch pain
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24 Percentage of participants
|
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Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Anal pain or bleeding
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2 Percentage of participants
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Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Lumbar/back pain
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15 Percentage of participants
|
|
Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Bone pain
|
17 Percentage of participants
|
|
Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Spinal compression symptoms
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1 Percentage of participants
|
|
Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Peripheral lymph node enlargement
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2 Percentage of participants
|
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Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Lymphatic oedema of the lower extremities
|
6 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline to 3, 6, 9, and 12 months.Population: Analysis conducted in the intent-to-treat population.
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.
Outcome measures
| Measure |
Advanced PCa Patients With LUTS Treated With GnRH Analogue
n=729 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)
|
|---|---|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
>Month 6 (n=719)
|
0 Units on a scale
Interval 0.0 to 5.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
>Month 12 (n=703)
|
0 Units on a scale
Interval 0.0 to 5.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Hematospermia (Baseline; n=729)
|
0 Units on a scale
Interval 0.0 to 5.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
>Month 3 (n=726)
|
0 Units on a scale
Interval 0.0 to 6.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
>Month 9 (n=704)
|
0 Units on a scale
Interval 0.0 to 6.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Lower abdominal pain (Baseline; n=729)
|
0 Units on a scale
Interval 0.0 to 7.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Urinary incontinence (Baseline; n=729)
|
0 Units on a scale
Interval 0.0 to 7.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Erectile dysfunction (Baseline; n=729)
|
4 Units on a scale
Interval 0.0 to 7.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Crotch pain (Baseline; n=729)
|
0 Units on a scale
Interval 0.0 to 7.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Anal pain or bleeding (Baseline; n=729)
|
0 Units on a scale
Interval 0.0 to 7.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Lumbar/back pain (Baseline n=729)
|
0 Units on a scale
Interval 0.0 to 7.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Bone pain (Baseline; n=729)
|
0 Units on a scale
Interval 0.0 to 7.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Spinal compression symptoms (Baseline; n=729)
|
0 Units on a scale
Interval 0.0 to 5.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Periph. lymph node enlargement (Baseline; n=729)
|
0 Units on a scale
Interval 0.0 to 7.0
|
|
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Lymphatic oedema, lower extrem. (Baseline; n=729)
|
0 Units on a scale
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Analysis conducted in the intent-to-treat population.
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.
Outcome measures
| Measure |
Advanced PCa Patients With LUTS Treated With GnRH Analogue
n=729 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)
|
|---|---|
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Reported Adverse Events/Serious Adverse Events
Experienced a serious AE
|
5 Participants
|
|
Reported Adverse Events/Serious Adverse Events
Experienced a non-serious AE
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3 Participants
|
|
Reported Adverse Events/Serious Adverse Events
Experienced both a serious AE and non-serious AE
|
1 Participants
|
Adverse Events
Advanced PCa Patients With LUTS Treated With GnRH Analogue
Serious adverse events
| Measure |
Advanced PCa Patients With LUTS Treated With GnRH Analogue
n=729 participants at risk
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)
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|---|---|
|
Renal and urinary disorders
Renal failure
|
0.14%
1/729 • Number of events 1 • Adverse events were collected from the first study visit (Baseline) through the last study visit (Month 12).
The adverse event population includes all enrolled participants.
|
|
Investigations
Blood creatinine increased
|
0.14%
1/729 • Number of events 1 • Adverse events were collected from the first study visit (Baseline) through the last study visit (Month 12).
The adverse event population includes all enrolled participants.
|
|
Investigations
Blood urea increased
|
0.14%
1/729 • Number of events 1 • Adverse events were collected from the first study visit (Baseline) through the last study visit (Month 12).
The adverse event population includes all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.14%
1/729 • Number of events 1 • Adverse events were collected from the first study visit (Baseline) through the last study visit (Month 12).
The adverse event population includes all enrolled participants.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.14%
1/729 • Number of events 1 • Adverse events were collected from the first study visit (Baseline) through the last study visit (Month 12).
The adverse event population includes all enrolled participants.
|
|
General disorders
Multi-organ failure
|
0.14%
1/729 • Number of events 1 • Adverse events were collected from the first study visit (Baseline) through the last study visit (Month 12).
The adverse event population includes all enrolled participants.
|
|
General disorders
Death
|
0.41%
3/729 • Number of events 3 • Adverse events were collected from the first study visit (Baseline) through the last study visit (Month 12).
The adverse event population includes all enrolled participants.
|
|
General disorders
Oedema peripheral
|
0.14%
1/729 • Number of events 1 • Adverse events were collected from the first study visit (Baseline) through the last study visit (Month 12).
The adverse event population includes all enrolled participants.
|
|
General disorders
Bone pain
|
0.14%
1/729 • Number of events 1 • Adverse events were collected from the first study visit (Baseline) through the last study visit (Month 12).
The adverse event population includes all enrolled participants.
|
|
Gastrointestinal disorders
Ascites
|
0.14%
1/729 • Number of events 1 • Adverse events were collected from the first study visit (Baseline) through the last study visit (Month 12).
The adverse event population includes all enrolled participants.
|
|
Investigations
Weight increased
|
0.14%
1/729 • Number of events 1 • Adverse events were collected from the first study visit (Baseline) through the last study visit (Month 12).
The adverse event population includes all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.14%
1/729 • Number of events 1 • Adverse events were collected from the first study visit (Baseline) through the last study visit (Month 12).
The adverse event population includes all enrolled participants.
|
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Services
Abbott
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection
- Publication restrictions are in place
Restriction type: OTHER