Trial · NCT00450619
153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer
NCT00450619, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-07-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. 153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer. Trials, record NCT00450619. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00450619
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer
- NCT number
- NCT00450619
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Prostate Cancer
- Interventions
- Samarium Sm 153 lexidronam pentasodium, Sargramostim, Recombinant vaccinia-TRICOM vaccine, Recombinant fowlpox-TRICOM vaccine
- First posted
- 2007-03-22
- Last updated
- 2017-01-04
- Results first posted
- 2013-07-01
- Limitations and caveats
- This study was stopped before full accrual(after about two-thirds of the subjects were enrolled) due to a significant decrease in enrollment despite making this a multicenter study.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Stable Disease at 4 Months. | 4.7 months | 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. |
| Primary | Progression Free Survival (PFS) | 4 months | PFS is defined as the time to progress or die after the start of the therapy. |
| Secondary | Toxicity | 5 years, 5 months | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
| Secondary | Number of Participants With Prostate-Specific Antigen (PSA) ≥ 30% | 4 months | 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. |
| Secondary | Number of Participants With Prostate-Specific Antigen (PSA) ≥50% | 4 months | 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. |
| Secondary | Overall Survival | From date of randomization until death or last follow up, whichever comes first, assessed up to 14 months. | Time from treatment start date until date of death or date last known alive. |
| Secondary | Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment | Approximately 60 days | PSA T-cell responses were measured by fluorescence activated cell sorting (FACS)-based assay for T-cells expressing type I cytokines interferon (IFN-ϓ), interleukin 2 (IL2), tumor necrosis factor alpha (TNF-a) and/or lysosome-associated membrane protein (CD107a). |
| Secondary | Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment | Approximately 60 days | PSA T-cell responses were measured by fluorescence activated cell sorting (FACS)-based assay for T-cells expressing type I cytokines interferon (IFN-ϓ), interleukin 2 (IL2), tumor necrosis factor alpha (TNF-a) and/or lysosome-associated membrane protein (CD107a). |
| Secondary | Objective Response (Complete Response + Partial Response) | 4 weeks | Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. 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. |
| Secondary | Palliation: Pain at Baseline | Baseline | Subjective report of participant pain at baseline.This data reflects National Cancer Institute (NCI) patients only. This data was not systematically captured, so these results are based on subjective patient reports of improvement in pain on a scale of 1-10 post quadramet (samarium) as documented in the progress notes. 1-2 equals mild pain and 9-10 equals worst possible pain. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Stable Disease at 4 Months. | 4.7 months | participants | NUMBER | |
| PRIMARY | Progression Free Survival (PFS) | 4 months | months | MEDIAN | |
| SECONDARY | Toxicity | 5 years, 5 months | Participants | NUMBER | |
| SECONDARY | Number of Participants With Prostate-Specific Antigen (PSA) ≥ 30% | 4 months | participants | NUMBER | |
| SECONDARY | Number of Participants With Prostate-Specific Antigen (PSA) ≥50% | 4 months | participants | NUMBER | |
| SECONDARY | Overall Survival | From date of randomization until death or last follow up, whichever comes first, assessed up to 14 months. | Months | MEDIAN | |
| SECONDARY | Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment | Approximately 60 days | (a)Cytokine or CD107a in CD4 or CD8. \*Pts displayed pre-existing PSA-specific T-cell responses. Numbers 274, 630, and 1427 are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation. | Absolute # CD4 or CD8 producing cytokine | NUMBER |
| SECONDARY | Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment | Approximately 60 days | (a)Cytokine or CD107a in CD4 or CD8. \*Pts displayed pre-existing PSA-specific T-cell responses. Numbers 786, 374, 345, 402, 821, 815, 5269, 453, 633, 1242 \& 0 for PT 2 CD4/CD8 IL2 \& 0 for PT 16 TNF are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation. | Absolute # CD4 or CD8 producing cytokine | NUMBER |
| SECONDARY | Objective Response (Complete Response + Partial Response) | 4 weeks | Not all participants was measureable by RECIST. | participants | NUMBER |
| SECONDARY | Palliation: Pain at Baseline | Baseline | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Stable Disease at 4 Months. | Arm A - EDTMP Alone | 2 | participants | ||
| Number of Patients With Stable Disease at 4 Months. | Arm B - 153Sm-EDTMP With Vaccine | 5 | participants | ||
| Progression Free Survival (PFS) | Arm A - EDTMP Alone | 1.7 | 95% Confidence Interval 1.3 to 2.3 | months | |
| Progression Free Survival (PFS) | Arm B - 153Sm-EDTMP With Vaccine | 3.7 | 95% Confidence Interval 2.4 to 4.7 | months | |
| Toxicity | Arm A - EDTMP Alone | 19 | Participants | ||
| Toxicity | Arm B - 153Sm-EDTMP With Vaccine | 22 | Participants | ||
| Number of Participants With Prostate-Specific Antigen (PSA) ≥ 30% | Arm A - EDTMP Alone | 0 | participants | ||
| Number of Participants With Prostate-Specific Antigen (PSA) ≥ 30% | Arm B - 153Sm-EDTMP With Vaccine | 4 | participants | ||
| Number of Participants With Prostate-Specific Antigen (PSA) ≥50% | Arm A - EDTMP Alone | 0 | participants | ||
| Number of Participants With Prostate-Specific Antigen (PSA) ≥50% | Arm B - 153Sm-EDTMP With Vaccine | 3 | participants |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A- EDTMP Alone | 22 | |
| Overall Study | STARTED | Arm B - 153Sm-EDTMP With Vaccine | 22 | |
| Overall Study | COMPLETED | Arm A- EDTMP Alone | 18 | |
| Overall Study | COMPLETED | Arm B - 153Sm-EDTMP With Vaccine | 21 | |
| Overall Study | NOT COMPLETED | Arm A- EDTMP Alone | 4 | |
| Overall Study | NOT COMPLETED | Arm B - 153Sm-EDTMP With Vaccine | 1 |
Source ClinicalTrials.gov
Adverse events250
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 | Alanine aminotransferase increased | Investigations | Arm A -EDTMP Alone | 4 | 21 | 4 |
| other | Alanine aminotransferase increased | Investigations | Arm B - 153SmEDTMP With Vaccine | 0 | 22 | 0 |
| other | Alkaline phosphatase increased | Investigations | Arm A -EDTMP Alone | 9 | 21 | 13 |
| other | Alkaline phosphatase increased | Investigations | Arm B - 153SmEDTMP With Vaccine | 10 | 22 | 15 |
| other | Anemia | Blood and lymphatic system disorders | Arm A -EDTMP Alone | 12 | 21 | 28 |
| other | Anemia | Blood and lymphatic system disorders | Arm B - 153SmEDTMP With Vaccine | 18 | 22 | 45 |
| other | Anorexia | Metabolism and nutrition disorders | Arm A -EDTMP Alone | 8 | 21 | 8 |
| other | Anorexia | Metabolism and nutrition disorders | Arm B - 153SmEDTMP With Vaccine | 8 | 22 | 11 |
| other | Anxiety | Psychiatric disorders | Arm A -EDTMP Alone | 1 | 21 | 1 |
| other | Anxiety | Psychiatric disorders | Arm B - 153SmEDTMP With Vaccine | 0 | 22 | 0 |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A -EDTMP Alone | ||
| Total, all-cause mortality | Arm B - 153SmEDTMP With Vaccine | ||
| Total, other adverse events | Arm A -EDTMP Alone | 19 | 21 |
| Total, other adverse events | Arm B - 153SmEDTMP With Vaccine | 22 | 22 |
| Total, serious adverse events | Arm A -EDTMP Alone | 5 | 21 |
| Total, serious adverse events | Arm B - 153SmEDTMP With Vaccine | 5 | 22 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A - EDTMP Alone vs Arm B - 153Sm-EDTMP With Vaccine: Number of Participants With Prostate-Specific Antigen (PSA) ≥ 30% | Trial comparisons |
| Arm A - EDTMP Alone vs Arm B - 153Sm-EDTMP With Vaccine: Number of Participants With Prostate-Specific Antigen (PSA) ≥50% | Trial comparisons |
| Arm A - EDTMP Alone vs Arm B - 153Sm-EDTMP With Vaccine: Toxicity | Trial comparisons |
| Arm A - EDTMP Alone vs Arm B - 153Sm-EDTMP With Vaccine: Palliation: Improvement in Baseline Pain | Trial comparisons |
| Arm A - EDTMP Alone vs Arm B - 153Sm-EDTMP With Vaccine: Palliation: Pain at Baseline | Trial comparisons |
| Arm A - EDTMP Alone vs Arm B - 153Sm-EDTMP With Vaccine: Number of Patients With Stable Disease at 4 Months. | Trial comparisons |
| Arm A -EDTMP Alone vs Arm B - 153SmEDTMP With Vaccine: serious adverse events | Trial comparisons |
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/NCT00450619
GET https://conductscience.org/api/trials/v1/NCT00450619/results?page=2