Comparison · NCT00450463-883eab80
Flutamide Alone vs Flutamide + Vaccine + Sargramostim: Number of Participants With Prostatic 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
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ConductScience Library. Flutamide Alone vs Flutamide + Vaccine + Sargramostim: Number of Participants With Prostatic Specific Antigen (PSA) Response. Trial comparisons, record NCT00450463-883eab80. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00450463-883eab80
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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 | 0.212 | 0.107 | 0.378 | wilson | |
| Risk in group 2 | 0.226 | 0.114 | 0.398 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0137 | -0.216 | 0.186 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.939 | 0.372 | 2.37 | log | |
| Odds ratio, group 1 over group 2 | 0.923 | 0.282 | 3.02 | log | |
| Number needed to treat, for one fewer participant with the outcome on Flutamide Alone than on Flutamide + Vaccine + Sargramostim | 73.1 | from the risk difference interval | the interval includes no difference |
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 | Flutamide Alone | Patients receive flutamide orally 3 times a day on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising prostatic specific antigen (PSA) levels) without metastatic disease (as evidenced on scans), may receive vaccine treatment as defined in arm II beginning 4 weeks after flutamide therapy is discontinued.~Flutamide (Eulexin): Orally administered, nonsteroidal, competitive antagonist of testosterone and other androgens at androgenic receptors and may alter the nuclear translocation of the androgen/receptor complex. | 7 | 33 | OG000 |
| Group 2 | Flutamide + Vaccine + Sargramostim | Patients receive flutamide orally 3 times a day on days 1-28. Patients also receive recombinant vaccinia PSA vaccine subcutaneously (SC) on day 1 of course 1 only and recombinant fowlpox PSA vaccine SC on day 1 of all subsequent courses. Patients receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising PSA levels), discontinue flutamide but may continue to receive vaccine treatment.~Sargramostim (GM-CSF, Leukine): A recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF) produced by recombinant deoxyribonucleic acid (DNA) technology in yeast Saccharomyces cerevisiae). | 7 | 31 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Prostatic Specific Antigen (PSA) Response
- Description
Complete response is PSA \<0.2 confirmed by a second reading at least 4 weeks later. All patients with a PSA decline of \>50% (confirmed by a second value at least 4 weeks after the first) and who have no other evidence of disease progression will be reported with both PSA decline only and PSA decline and stable disease on scans. A 25% increase in PSA over nadir is progressive disease with or without evidence of metastatic disease, and/or development of disease on scans or a second occurrence of rising PSA levels in the absence of clinical progression.
- Time frame
- Median potential follow-up for all patients is 46.7 months
- Population
Although patients without radiographic progression were allowed to get vaccine after progression on flutamide, the primary comparison in the two groups of this study was Flutamide alone vs. Fluatmiade + vaccine simultaneously.
Source ClinicalTrials.gov
Trial
- Title
- Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer
- NCT number
- NCT00450463
- Phases
- PHASE2
- Conditions
- Prostate Cancer
- Interventions
- Sargramostim (GM-CSF, Leukine), Flutamide (Eulexin), PROSTVAC-F/ TRICOM, PROSTVAC-V/TRICOM
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2018-11-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00450463?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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