Comparison · NCT00450619-4fd5d162
Arm A - EDTMP Alone vs Arm B - 153Sm-EDTMP With Vaccine: Number of Patients With Stable Disease at 4 Months.
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 Patients With Stable Disease at 4 Months. Trial comparisons, record NCT00450619-4fd5d162. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00450619-4fd5d162
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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 | 0.111 | 0.031 | 0.328 | wilson | |
| Risk in group 2 | 0.238 | 0.106 | 0.451 | wilson | |
| Risk difference, group 1 minus group 2 | -0.127 | -0.354 | 0.127 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.467 | 0.103 | 2.12 | log | |
| Odds ratio, group 1 over group 2 | 0.4 | 0.0674 | 2.37 | log | |
| Number needed to treat, for one fewer participant with the outcome on Arm A - EDTMP Alone than on Arm B - 153Sm-EDTMP With Vaccine | 7.88 | 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. | 2 | 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. | 5 | 21 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients With Stable Disease at 4 Months.
- Description
Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Stable disease is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Partial response (PR) is at least a 30% increase in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions on computed tomography (CT) or two or more lesions on bone scan.
- Time frame
- 4.7 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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