Comparison · NCT00537381-0d01fef9
Docetaxel + Prednisone + Placebo vs Docetaxel + Prednisone + Intetumumab: Number of Participants With Prostate Specific Antigen (PSA) Response
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Docetaxel + Prednisone + Placebo vs Docetaxel + Prednisone + Intetumumab: Number of Participants With Prostate Specific Antigen (PSA) Response. Trial comparisons, record NCT00537381-0d01fef9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00537381-0d01fef9
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.683 | 0.56 | 0.784 | wilson | |
| Risk in group 2 | 0.466 | 0.343 | 0.592 | wilson | |
| Risk difference, group 1 minus group 2 | 0.217 | 0.0409 | 0.376 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.47 | 1.06 | 2.03 | log | |
| Odds ratio, group 1 over group 2 | 2.47 | 1.18 | 5.17 | log | |
| Number needed to treat, for one more participant with the outcome on Docetaxel + Prednisone + Placebo than on Docetaxel + Prednisone + Intetumumab | 4.61 | 2.66 | 24.5 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Docetaxel + Prednisone + Placebo | Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m\^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone. | 43 | 63 | OG000 |
| Group 2 | Docetaxel + Prednisone + Intetumumab | Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m\^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. | 27 | 58 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Prostate Specific Antigen (PSA) Response
- Description
The PSA response is defined as at least a 50 percent decrease in PSA below the baseline value, confirmed by a second PSA value greater than or equal to 6 weeks later. A participant was considered to be a PSA responder if and only if the response occurs prior to PSA progression (increase of at least 25 percent and an increase of 5 nanogram per milliliter from the lowest observed PSA value since initiation of treatment, to be confirmed greater than or equal to 3 weeks later).
- Time frame
- Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days
- Population
- Included all participants randomly assigned to study treatment and had baseline PSA evaluation and at least two post-baseline evaluations that are at least 3 weeks apart.
Source ClinicalTrials.gov
Trial
- Title
- An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer
- NCT number
- NCT00537381
- Phases
- PHASE2
- Conditions
- Prostatic Neoplasms
- Interventions
- Docetaxel, Prednisone, Intetumumab, Placebo
- Lead sponsor
- Centocor, Inc.
- Results first posted
- 2013-05-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00537381?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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