Trial · NCT02463799
Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC
NCT02463799, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2021-07-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC. Trials, record NCT02463799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02463799
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC
- NCT number
- NCT02463799
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Prostate Cancer
- Interventions
- Radium-223, Sipuleucel-T
- First posted
- 2015-06-04
- Last updated
- 2021-07-08
- Results first posted
- 2021-07-08
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immune Responses to Treatment With Sipuleucel-T (With or Without Radium-223) Measured by Peripheral PA2024 T-cell Proliferation | 6 weeks | Peripheral PA2024-specific T-cell proliferation responses using a 3H-thymidine incorporation assay at 6 weeks after the first dose of sipuleucel-T, measured by SI (Stimulation Index \[3H-thymidine incorporation in the presence of antigen divided by 3H-thymidine incorporation with media alone\] ). |
| Secondary | Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time | Up to 52 weeks | Mean peripheral PA2024 specific T-cell proliferation using a 3H-thymidine incorporation assay reported as SI (Stimulation Index \[3H-thymidine incorporation in the presence of antigen divided by 3H-thymidine incorporation with media alone\] ) at baseline and 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T. |
| Secondary | Time to Radiographic or Clinical Progression | Up to 2 years | Number of weeks from baseline until radiographic or clinical progression, whichever comes first. Radiographic progression is assessed by RECIST (Response Evaluation Criteria in Solid Tumors) and PCWG2 criteria (Prostate Cancer Working Group 2). Per RECIST, progression is defined as ≥ 20% and ≥ 5 mm from nadir of the sum of the diameters of target lesions. Per PCWG2 criteria, radiographic progression is defined as ≥ 20% sum of the longest diameter of target lesions, or ≥ 2 new lesions on bone scan from baseline. Clinical progression is defined as new spinal cord or nerve root compression, new pathologic fracture or use of opioid analgesics for cancer-related pain. |
| Secondary | PSA50 Response (at Least a 50% Decline in PSA) | Up to 2 years | Number of participants with PSA50 response defined as at least a 50% decline in Prostate Specific Antigen (PSA) from baseline value |
| Secondary | Peripheral PAP Specific T-cell Proliferation as Measured by Stimulation Index Over Time | Up to 52 weeks | Mean peripheral PAP specific T-cell proliferation using a 3H-thymidine incorporation assay reported as SI (Stimulation Index \[3H-thymidine incorporation in the presence of antigen divided by 3H-thymidine incorporation with media alone\] ) at baseline and 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T |
| Secondary | Peripheral PA2024 Specific T-cell Activation | Up to 52 weeks | Mean peripheral PA2024 specific T-cell activation to sipuleucel-T using interferon gamma (IFNγ) enzyme-linked immunosorbent spot (ELISPOT), as measured by cells per 300,000 PBMCs at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T. |
| Secondary | Peripheral PAP Specific T-cell Activation | Up to 52 weeks | Mean peripheral PAP specific T-cell activation to sipuleucel-T using interferon gamma (IFNγ) enzyme-linked immunosorbent spot (ELISPOT) measured as cells per 300,000 PBMCs at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T. |
| Secondary | PA2024 Specific Antibody (IgM) Response | Up to 52 weeks | Mean titer of PA2024 specific antibody (IgM) response to sipuleucel-T using enzyme-linked immunosorbent assay (ELISA) at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T. |
| Secondary | PA2024 Specific Antibody (IgG) Response | Up to 52 weeks | Mean titer of PA2024 specific antibody (IgG) response to sipuleucel-T using enzyme-linked immunosorbent assay (ELISA) at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T. |
| Secondary | PAP Specific Antibody (IgG) Response Over Time | Up to 52 weeks | Mean titer of PAP specific antibody (IgG) response to sipuleucel-T using enzyme-linked immunosorbent assay (ELISA) at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Immune Responses to Treatment With Sipuleucel-T (With or Without Radium-223) Measured by Peripheral PA2024 T-cell Proliferation | 6 weeks | fold change | MEDIAN | |
| SECONDARY | Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time | Up to 52 weeks | Data was only collected from 13 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 10 out of 16 participants in the Sipuleucel-T arm | Stimulation Index | MEAN |
| SECONDARY | Time to Radiographic or Clinical Progression | Up to 2 years | WEEKS | MEDIAN | |
| SECONDARY | PSA50 Response (at Least a 50% Decline in PSA) | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Peripheral PAP Specific T-cell Proliferation as Measured by Stimulation Index Over Time | Up to 52 weeks | Data was only collected from 13 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 10 out of 16 participants in the Sipuleucel-T arm | Stimulation Index | MEAN |
| SECONDARY | Peripheral PA2024 Specific T-cell Activation | Up to 52 weeks | Data was only collected from 13 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 10 out of 16 participants in the Sipuleucel-T arm | cells per 300,000 PBMCs | MEAN |
| SECONDARY | Peripheral PAP Specific T-cell Activation | Up to 52 weeks | Data was only collected from 13 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 10 out of 16 participants in the Sipuleucel-T arm | cells per 300,000 PBMCs | MEAN |
| SECONDARY | PA2024 Specific Antibody (IgM) Response | Up to 52 weeks | Data was only collected from 14 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 14 out of 16 participants in the Sipuleucel-T arm | titer | MEAN |
| SECONDARY | PA2024 Specific Antibody (IgG) Response | Up to 52 weeks | Data was only collected from 14 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 14 out of 16 participants in the Sipuleucel-T arm | titer | MEAN |
| SECONDARY | PAP Specific Antibody (IgG) Response Over Time | Up to 52 weeks | Data was only collected from 14 out of 16 participants in the Sipuleucel-T and radium 223 combination arm and 14 out of 16 participants in the Sipuleucel-T arm | titer | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Immune Responses to Treatment With Sipuleucel-T (With or Without Radium-223) Measured by Peripheral PA2024 T-cell Proliferation | Sipuleucel-T and Radium 223 Combination | 7.0 | Inter-Quartile Range 4.12 to 20.2 | fold change | |
| Immune Responses to Treatment With Sipuleucel-T (With or Without Radium-223) Measured by Peripheral PA2024 T-cell Proliferation | Sipuleucel-T Alone | 22.4 | Inter-Quartile Range 17.2 to 31.4 | fold change | |
| Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time | Sipuleucel-T and Radium 223 Combination | Baseline | 1.7 | Inter-Quartile Range 1.0 to 2.2 | Stimulation Index |
| Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time | Sipuleucel-T Alone | Baseline | 1.4 | Inter-Quartile Range 1.2 to 1.5 | Stimulation Index |
| Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time | Sipuleucel-T and Radium 223 Combination | Week 6 | 25.7 | Inter-Quartile Range 4.4 to 37.0 | Stimulation Index |
| Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time | Sipuleucel-T Alone | Week 6 | 49.8 | Inter-Quartile Range 30.5 to 44.5 | Stimulation Index |
| Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time | Sipuleucel-T and Radium 223 Combination | Week 10 | 27.8 | Inter-Quartile Range 8.6 to 34.2 | Stimulation Index |
| Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time | Sipuleucel-T Alone | Week 10 | 42.0 | Inter-Quartile Range 26.3 to 56.0 | Stimulation Index |
| Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time | Sipuleucel-T and Radium 223 Combination | Week 14 | 23.0 | Inter-Quartile Range 7.0 to 21.8 | Stimulation Index |
| Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time | Sipuleucel-T Alone | Week 14 | 42.2 | Inter-Quartile Range 32.1 to 56.1 | Stimulation Index |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sipuleucel-T and Radium 223 Combination | 16 | |
| Overall Study | STARTED | Sipuleucel-T Alone | 16 | |
| Overall Study | COMPLETED | Sipuleucel-T and Radium 223 Combination | 16 | |
| Overall Study | COMPLETED | Sipuleucel-T Alone | 16 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T and Radium 223 Combination | 0 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T Alone | 0 |
Source ClinicalTrials.gov
Adverse events48
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 | Pain | General disorders | Sipuleucel-T and Radium 223 Combination | 12 | 16 | 12 |
| other | Pain | General disorders | Sipuleucel-T Alone | 12 | 16 | 12 |
| other | Chills | General disorders | Sipuleucel-T and Radium 223 Combination | 2 | 16 | 2 |
| other | Chills | General disorders | Sipuleucel-T Alone | 6 | 16 | 6 |
| other | Fatigue | General disorders | Sipuleucel-T and Radium 223 Combination | 5 | 16 | 5 |
| other | Fatigue | General disorders | Sipuleucel-T Alone | 3 | 16 | 3 |
| other | Flu Like Symptoms | General disorders | Sipuleucel-T and Radium 223 Combination | 4 | 16 | 4 |
| other | Flu Like Symptoms | General disorders | Sipuleucel-T Alone | 3 | 16 | 3 |
| other | Fever | General disorders | Sipuleucel-T and Radium 223 Combination | 2 | 16 | 2 |
| other | Fever | General disorders | Sipuleucel-T Alone | 1 | 16 | 1 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sipuleucel-T and Radium 223 Combination | 0 | 16 |
| Total, all-cause mortality | Sipuleucel-T Alone | 0 | 16 |
| Total, other adverse events | Sipuleucel-T and Radium 223 Combination | 12 | 16 |
| Total, other adverse events | Sipuleucel-T Alone | 12 | 16 |
| Total, serious adverse events | Sipuleucel-T and Radium 223 Combination | 2 | 16 |
| Total, serious adverse events | Sipuleucel-T Alone | 1 | 16 |
Source ClinicalTrials.gov
Papers2
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sipuleucel-T and Radium 223 Combination vs Sipuleucel-T Alone: PSA50 Response (at Least a 50% Decline in PSA) | Trial comparisons |
| Sipuleucel-T and Radium 223 Combination vs Sipuleucel-T Alone: deaths from any cause | Trial comparisons |
| Sipuleucel-T and Radium 223 Combination vs Sipuleucel-T Alone: 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/NCT02463799
GET https://conductscience.org/api/trials/v1/NCT02463799/results?page=2