Trial · NCT01081873
Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer
NCT01081873, Completed, Abbott; results first posted 2012-03-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer. Trials, record NCT01081873. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01081873
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer
- NCT number
- NCT01081873
- Status
- Completed
- Enrollment
- 2,717 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Prostatic Neoplasm
- Interventions
- leuprolide (Lucrin/Lucrin-Tri-depot)
- First posted
- 2010-03-05
- Last updated
- 2012-10-31
- Results first posted
- 2012-03-26
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first | The number of participants with metastases that are absent, local tumor, single metastases, multiple metastases in 1 organ, and multiple metastases in multiple organs at each visit is summarized. |
| Primary | Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit | time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first | The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented. |
| Primary | Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit | month 3, and every 3 months until disease progression or up to 24 months, whichever came first | Response to treatment is summarized by the number of participants at each visit with a complete or partial response, stable disease, or progressive disease. Disease status determination was not predefined, but was based on the judgement of each Investigator. |
| Primary | Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months | time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first | The prognosis for participants is summarized for each visit by the number of participants at each visit with a survival prognosis of 10 years, 5 - 10 years, 1 - 5 years, 6 - 12 months, and \< 6 months. Methods for determining survival prognosis were not prespecified, but were based on the judgement of each Investigator. |
| Primary | Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy. | time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first | Prostate cancer treatment for all participants is summarized by the number of participants at each visit who took any Lucrin/Lucrin Tridepot, LHRH agonist, anti-androgens, or other drug treatments, or who had any type of surgery or radiotherapy (external radiation or brachytherapy). |
| Secondary | Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs) | Baseline to disease progression or 24 months, whichever came first | The number of participants experiencing a serious adverse event during the course of the study is summarized. See the Reported Adverse Event section for details. |
| Secondary | Epidemiological Data: Mean Weight | at time 0 (Baseline) | The mean weight of all participants at baseline is provided. |
| Secondary | Epidemiological Data: Mean Age | at time 0 (Baseline) | The mean age of all participants at baseline is provided. |
| Secondary | Epidemiological Data: Race | at time 0 (Baseline) | The number of participants by race at baseline is presented. |
| Secondary | Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy. | at time 0 (Baseline) | Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit. | participants | NUMBER |
| PRIMARY | Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit | time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit. | ng/mL | MEAN |
| PRIMARY | Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit | month 3, and every 3 months until disease progression or up to 24 months, whichever came first | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit. | participants | NUMBER |
| PRIMARY | Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months | time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit. | participants | NUMBER |
| PRIMARY | Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy. | time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit. | participants | NUMBER |
| SECONDARY | Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs) | Baseline to disease progression or 24 months, whichever came first | Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. | participants | NUMBER |
| SECONDARY | Epidemiological Data: Mean Weight | at time 0 (Baseline) | Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients. | kg | MEAN |
| SECONDARY | Epidemiological Data: Mean Age | at time 0 (Baseline) | Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients. | years | MEAN |
| SECONDARY | Epidemiological Data: Race | at time 0 (Baseline) | Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for race was available for 2,217 patients. | participants | NUMBER |
| SECONDARY | Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy. | at time 0 (Baseline) | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data. | participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group247
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | Advanced Prostate Cancer Participants at Baseline | Absent | 782 | participants | |
| Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | Advanced Prostate Cancer Participants at Month 3 | Absent | 59 | participants | |
| Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | Advanced Prostate Cancer Participants at Month 6 | Absent | 45 | participants | |
| Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | Advanced Prostate Cancer Participants at Month 9 | Absent | 28 | participants | |
| Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | Advanced Prostate Cancer Participants at Month 12 | Absent | 74 | participants | |
| Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | Advanced Prostate Cancer Participants at Month 15 | Absent | 33 | participants | |
| Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | Advanced Prostate Cancer Participants at Month 18 | Absent | 44 | participants | |
| Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | Advanced Prostate Cancer Participants at Month 21 | Absent | 29 | participants | |
| Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | Advanced Prostate Cancer Participants at Month 24 | Absent | 188 | participants | |
| Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | Advanced Prostate Cancer Participants - Last Available Record | Absent | 870 | participants |
1 to 10 of 247Source ClinicalTrials.gov
See all 247 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Advanced Prostate Cancer Participants | 2,714 | |
| Overall Study | COMPLETED | Advanced Prostate Cancer Participants | 2,416 | |
| Overall Study | NOT COMPLETED | Advanced Prostate Cancer Participants | 298 |
Source ClinicalTrials.gov
Adverse events113
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 |
|---|---|---|---|---|---|---|
| other | Porphyria non-acute | Congenital, familial and genetic disorders | Advanced Prostate Cancer Participants | 1 | 2,714 | 1 |
| other | Fatigue | General disorders | Advanced Prostate Cancer Participants | 1 | 2,714 | 1 |
| other | Osteopenia | Musculoskeletal and connective tissue disorders | Advanced Prostate Cancer Participants | 1 | 2,714 | 1 |
| other | Syncope | Nervous system disorders | Advanced Prostate Cancer Participants | 1 | 2,714 | 1 |
| other | Urinary retention | Renal and urinary disorders | Advanced Prostate Cancer Participants | 1 | 2,714 | 1 |
| other | Gynaecomastia | Reproductive system and breast disorders | Advanced Prostate Cancer Participants | 1 | 2,714 | 1 |
| other | Hot flush | Vascular disorders | Advanced Prostate Cancer Participants | 2 | 2,714 | 2 |
| serious | Anaemia | Blood and lymphatic system disorders | Advanced Prostate Cancer Participants | 1 | 2,714 | |
| serious | Neutropenia | Blood and lymphatic system disorders | Advanced Prostate Cancer Participants | 1 | 2,714 | |
| serious | Acute myocardial infarction | Cardiac disorders | Advanced Prostate Cancer Participants | 1 | 2,714 |
1 to 10 of 113Source ClinicalTrials.gov
See all 113 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Advanced Prostate Cancer Participants | ||
| Total, other adverse events | Advanced Prostate Cancer Participants | 8 | 2,714 |
| Total, serious adverse events | Advanced Prostate Cancer Participants | 121 | 2,714 |
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/NCT01081873
GET https://conductscience.org/api/trials/v1/NCT01081873/results?page=2