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In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically to the concurrently administered immunotherapy Sipuleucel-T and thereby significantly improve the treatment outcome for metastatic castrate resistant prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR are FDA approved therapeutic cancer treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm one | Experimental | Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sipuleucel-T | Drug |
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| |
| Stereotactic Ablative Body Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | 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/. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Response | 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. | 6 week |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raquibul Hannan, MD, PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation) | Sipuleucel-T (brand name Provenge) IV infusion and Stereotactic Ablative Body Radiation (SABR) dose varying from 21 Gy-33 Gy in 1-3 fractions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2019 |
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| Radiation |
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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. |
| 60 months |
| Progression Free Survival (PFS) | 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. | 4 years |
| Biochemical Progression Free Survival (bPFS) | 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. | 4 years |
| Prostate Cancer-specific Survival (PCaSS) | 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 | 4 years |
| Adverse Events | 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 | 60 months |
| Cost Effectiveness and Health-related Quality Adjusted Life | To evaluate the cost effectiveness and health-related quality adjusted life of the combination treatment of SABR and sipuleucel T in patients with mCRPC. | 4 years |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm One | Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) Sipuleucel-T Stereotactic Ablative Body Radiation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline performance status | Zubrod Performance Scale will be used: 0 Fully active, able to carry on all predisease activities without restriction;
| Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Progression | 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/. | Posted | Median | 95% Confidence Interval | weeks | 4 years |
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| Secondary | Immune Response | 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. | Posted | Number | percentage of participants | 6 week |
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| Secondary | Overall Survival (OS) | 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. | Posted | Median | 95% Confidence Interval | number of weeks | 60 months |
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| Secondary | Progression Free Survival (PFS) | 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. | Posted | Median | 95% Confidence Interval | number of weeks | 4 years |
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| Secondary | Biochemical Progression Free Survival (bPFS) | 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. | Posted | Median | 95% Confidence Interval | number of weeks | 4 years |
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| Secondary | Prostate Cancer-specific Survival (PCaSS) | 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 | Posted | Number | percentage of participants | 4 years |
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| Secondary | Adverse Events | 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 | Posted | Number | number of events | 60 months |
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| Secondary | Cost Effectiveness and Health-related Quality Adjusted Life | To evaluate the cost effectiveness and health-related quality adjusted life of the combination treatment of SABR and sipuleucel T in patients with mCRPC. | 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. | Posted | 4 years |
|
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60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: 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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm One | Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) Sipuleucel-T Stereotactic Ablative Body Radiation | 19 | 20 | 0 | 20 | 20 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline Phosphatase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fatigue | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Headaches | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hot Flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Lymphocyte Count Decrease | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Photosensitivity | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Rectal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Rectal Urgency | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Thrombolic Event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary Tract Obstruction | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| White blood cells decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raquibul Hannan | University of Texas Southwestern Medical Center Dallas | 214-645-7696 | raquibul.Hannan@UTSouthwestern.edu |
| Apr 6, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C511774 | sipuleucel-T |
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| Asian |
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