Trial · NCT01078545
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
NCT01078545, Completed, Abbott; results first posted 2012-01-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS). Trials, record NCT01078545. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01078545
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
- NCT number
- NCT01078545
- Status
- Completed
- Enrollment
- 729 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Advanced Prostate Cancer, Lower Urinary Tract Symptoms
- Interventions
- Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)
- First posted
- 2010-03-02
- Last updated
- 2012-01-16
- Results first posted
- 2012-01-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35. | 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 | The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | 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. |
| Secondary | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | 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. |
| Secondary | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | 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. |
| Secondary | Reported Adverse Events/Serious Adverse Events | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35. | Baseline to 12 months | Analysis conducted in the intent-to-treat population. | units on a scale | MEAN |
| SECONDARY | The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | Baseline to 3, 6, 9, and 12 months. | Analysis conducted in the intent-to-treat population. | units on a scale | MEAN |
| SECONDARY | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Baseline | Analysis conducted in the intent-to-treat population. | Percentage of participants | NUMBER |
| SECONDARY | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Baseline to 3, 6, 9, and 12 months. | Analysis conducted in the intent-to-treat population. | Units on a scale | MEDIAN |
| SECONDARY | Reported Adverse Events/Serious Adverse Events | Baseline to 12 months | Analysis conducted in the intent-to-treat population. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35. | Advanced PCa Patients With LUTS Treated With GnRH Analogue | IPSS at Baseline (n=727) | 17.8 | Standard Deviation 6.9 | units on a scale |
| The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35. | Advanced PCa Patients With LUTS Treated With GnRH Analogue | IPSS at 12 months (n=699) | 10.0 | Standard Deviation 5.0 | units on a scale |
| The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | Advanced PCa Patients With LUTS Treated With GnRH Analogue | IPSS at Baseline (n=727) | 17.8 | Standard Deviation 6.9 | units on a scale |
| The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | Advanced PCa Patients With LUTS Treated With GnRH Analogue | IPSS at month 3 (n=724) | 14.0 | Standard Deviation 5.6 | units on a scale |
| The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | Advanced PCa Patients With LUTS Treated With GnRH Analogue | IPSS at month 6 (n=717) | 12.3 | Standard Deviation 5.1 | units on a scale |
| The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | Advanced PCa Patients With LUTS Treated With GnRH Analogue | IPSS at month 9 (n=702) | 10.9 | Standard Deviation 4.9 | units on a scale |
| The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | Advanced PCa Patients With LUTS Treated With GnRH Analogue | IPSS at month 12 (n=699) | 10.0 | Standard Deviation 5.0 | units on a scale |
| Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Advanced PCa Patients With LUTS Treated With GnRH Analogue | Hematospermia | 3 | Percentage of participants | |
| Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Advanced PCa Patients With LUTS Treated With GnRH Analogue | Lower abdominal pain | 31 | Percentage of participants | |
| Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Advanced PCa Patients With LUTS Treated With GnRH Analogue | Urine incontinence | 13 | Percentage of participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 729 | |
| Overall Study | Intent-to-treat Population | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 729 | |
| Overall Study | Per Protocol Population | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 661 | |
| Overall Study | COMPLETED | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 703 | |
| Overall Study | NOT COMPLETED | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 26 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Renal failure | Renal and urinary disorders | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 1 | 729 | 1 |
| serious | Blood creatinine increased | Investigations | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 1 | 729 | 1 |
| serious | Blood urea increased | Investigations | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 1 | 729 | 1 |
| serious | Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 1 | 729 | 1 |
| serious | Cardiovascular insufficiency | Cardiac disorders | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 1 | 729 | 1 |
| serious | Multi-organ failure | General disorders | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 1 | 729 | 1 |
| serious | Death | General disorders | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 3 | 729 | 3 |
| serious | Oedema peripheral | General disorders | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 1 | 729 | 1 |
| serious | Bone pain | General disorders | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 1 | 729 | 1 |
| serious | Ascites | Gastrointestinal disorders | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 1 | 729 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Advanced PCa Patients With LUTS Treated With GnRH Analogue | ||
| Total, other adverse events | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 0 | 729 |
| Total, serious adverse events | Advanced PCa Patients With LUTS Treated With GnRH Analogue | 6 | 729 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01078545
GET https://conductscience.org/api/trials/v1/NCT01078545/results?page=2