Trial · NCT01818986
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)
NCT01818986, Phase 2, Completed, University of Texas Southwestern Medical Center; results first posted 2022-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC). Trials, record NCT01818986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01818986
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)
- NCT number
- NCT01818986
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Metastatic Castrate-resistant Prostate Cancer, mCRPC
- Interventions
- Sipuleucel-T, Stereotactic Ablative Body Radiation
- First posted
- 2013-03-27
- Last updated
- 2022-05-06
- Results first posted
- 2022-05-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Progression | 4 years | To evaluate the improvement in the time to progression (TTP) of metastatic prostate cancer after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Progression will be evaluated in this study using the modified new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Committee \[JNCI 92(3):205-216, 2000\] with modifications suggested by PCWG2 \[49\] recommendations and as used in the Phase III clinical trial by Kantoff et. al.\[10\]. Changes in only the largest diameter (one-dimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria as outlined in http://www.recist.com/. |
| Secondary | Immune Response | 6 week | To evaluate the percentage of participants with Immune response at 6 weeks. Immune response will be measured using ELISpot assay (with PA2024). An immune endpoint will be reached by the patient if a \>100% increase in immune response is measured by ANY of the assays. |
| Secondary | Overall Survival (OS) | 60 months | To evaluate the improvement in the overall survival (OS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Overall survival (OS) was defined as the duration of time from the start of treatment to the time of death from any cause. |
| Secondary | Progression Free Survival (PFS) | 4 years | To evaluate the improvement in the progression free survival (PFS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Progression free survival (PFS) was defined as the length of time from the start of treatment to disease progression or death from any cause. |
| Secondary | Biochemical Progression Free Survival (bPFS) | 4 years | To evaluate the improvement in the biochemical progression free survival (bPFS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Biochemical progression free survival was defined as the time from the beginning of treatment to PSA (prostate-specific antigen) disease progression. Biochemical progression was defined as an increase in PSA of \> 2 ng/ml from baseline and an increase of \> 25% from the baseline value and confirmed by a second measurement more than three weeks later. |
| Secondary | Prostate Cancer-specific Survival (PCaSS) | 4 years | To evaluate the improvement in the prostate cancer-specific survival (PCaSS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Prostate cancer-specific survival was defined as the percentage of patients who had not died from prostate cancer at the time of analysis |
| Secondary | Adverse Events | 60 months | To evaluate the adverse events for the first 6 months after completion of radiation therapy associated with Sipuleucel-T when administered in combination with SABR to metastatic sites, as compared to the historically reported data with the treatment of Sipuleucel-T alone. Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Adverse events not specifically defined in the NCI CTCAE will be scored on the Adverse Event log according to the general guidelines provided by the NCI CTCAE and as outlined: Grade 1: Mild Grade 2: Moderate Grade 3: Severe or medically significant but not immediately life threatening Grade 4: Life threatening consequences Grade 5: Death related to the adverse event |
| Secondary | Cost Effectiveness and Health-related Quality Adjusted Life | 4 years | To evaluate the cost effectiveness and health-related quality adjusted life of the combination treatment of SABR and sipuleucel T in patients with mCRPC. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Progression | 4 years | weeks | MEDIAN | |
| SECONDARY | Immune Response | 6 week | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) | 60 months | number of weeks | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) | 4 years | number of weeks | MEDIAN | |
| SECONDARY | Biochemical Progression Free Survival (bPFS) | 4 years | number of weeks | MEDIAN | |
| SECONDARY | Prostate Cancer-specific Survival (PCaSS) | 4 years | percentage of participants | NUMBER | |
| SECONDARY | Adverse Events | 60 months | number of events | NUMBER | |
| SECONDARY | Cost Effectiveness and Health-related Quality Adjusted Life | 4 years | This data was not collected per protocol. The objective in question was intended to be an exploratory objective rather than a primary objective. However, due to an error in protocol modification, this change did not occur. |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Progression | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | 11.2 | 95% Confidence Interval 6.8 to 14.0 | weeks | |
| Immune Response | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | 50 | percentage of participants | ||
| Overall Survival (OS) | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | 76.8 | 95% Confidence Interval 41.6 to 130.8 | number of weeks | |
| Progression Free Survival (PFS) | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | 10.4 | 95% Confidence Interval 6.4 to 13.9 | number of weeks | |
| Biochemical Progression Free Survival (bPFS) | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | 12.5 | 95% Confidence Interval 4.8 to 33.5 | number of weeks | |
| Prostate Cancer-specific Survival (PCaSS) | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | 5 | percentage of participants | ||
| Adverse Events | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | Grade 1 | 51 | number of events | |
| Adverse Events | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | Grade 2 | 8 | number of events | |
| Adverse Events | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | Grade 3 | 4 | number of events |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | 20 | |
| Overall Study | COMPLETED | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | 20 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | 0 |
Source ClinicalTrials.gov
Adverse events33
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 | Alkaline Phosphatase Increased | Investigations | Arm One | 1 | 20 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Arm One | 1 | 20 | 1 |
| other | Anxiety | Psychiatric disorders | Arm One | 2 | 20 | 2 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Arm One | 1 | 20 | 1 |
| other | Chills | General disorders | Arm One | 3 | 20 | 3 |
| other | Constipation | Gastrointestinal disorders | Arm One | 1 | 20 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Arm One | 1 | 20 | 1 |
| other | Dehydration | Metabolism and nutrition disorders | Arm One | 1 | 20 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Arm One | 2 | 20 | 2 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Arm One | 3 | 20 | 3 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm One | 19 | 20 |
| Total, other adverse events | Arm One | 20 | 20 |
| Total, serious adverse events | Arm One | 0 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01818986
GET https://conductscience.org/api/trials/v1/NCT01818986/events?page=2