Comparison · NCT00450619-151de2d9
Arm A - EDTMP Alone vs Arm B - 153Sm-EDTMP With Vaccine: Number of Participants With Prostate-Specific Antigen (PSA) ≥50%
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. Arm A - EDTMP Alone vs Arm B - 153Sm-EDTMP With Vaccine: Number of Participants With Prostate-Specific Antigen (PSA) ≥50%. Trial comparisons, record NCT00450619-151de2d9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00450619-151de2d9
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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 | 0 | 0.176 | wilson | |
| Risk in group 2 | 0.143 | 0.0498 | 0.346 | wilson | |
| Risk difference, group 1 minus group 2 | -0.143 | -0.346 | 0.0561 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Arm A - EDTMP Alone than on Arm B - 153Sm-EDTMP With Vaccine | 7 | 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 | Arm A - EDTMP Alone | Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity. | 0 | 18 | OG000 |
| Group 2 | Arm B - 153Sm-EDTMP With Vaccine | Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I. | 3 | 21 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Prostate-Specific Antigen (PSA) ≥50%
- Description
- PSA is defined by the PSA Working Group criteria. A minimum PSA decline of at least 50% must be confirmed by a second PSA value 4 or more weeks later.
- Time frame
- 4 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- 153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer
- NCT number
- NCT00450619
- Phases
- PHASE2
- Conditions
- Prostate Cancer
- Interventions
- Samarium Sm 153 lexidronam pentasodium, Sargramostim, Recombinant vaccinia-TRICOM vaccine, Recombinant fowlpox-TRICOM vaccine
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2013-07-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00450619?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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