Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IRB00056435 | Other Identifier | JHM IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dendreon | INDUSTRY |
| Bayer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial studies the effect of radium-223 when added to sipuleucel-T for treating castrate-resistant prostate cancer that has spread to the bone. Sipuleucel-T is an autologous cellular immunotherapy designed to stimulate an immune response against prostate cancer. It has been suggested that the immune response may be strengthened by radiation therapy. Therefore this study is testing whether radium-223 added to sipuleucel-T increases the immune response and anti-tumor effect against prostate cancer.
This is a randomized study designed to assess the antigen-specific immune response of sipuleucel-T with or without radium-223. Eligible subjects will be registered and randomly assigned in a 1:1 ratio to receive sipuleucel-T and radium-223 or sipuleucel-T alone.
Subjects in both arms (sipuleucel-T and radium) will undergo a standard 1.5 to 2.0 blood volume leukapheresis, followed approximately 3 days later by an IV infusion of sipuleucel-T. This process will occur a total of 3 times at approximately 2-week intervals. Subjects in Arm 1 will receive a total of 6 infusions of radium-223 at IV dose of 50 kBq/kg at 4-week interval.
All participants are allowed to receive the best supportive care which includes secondary hormonal manipulation as required. No chemotherapy, external-beam radiation, or other radionuclides are allowed while on active treatment but are permitted after completion of active treatment. Glucocorticoid-containing treatments should be minimized to less than the equivalent dose of prednisone 10mg daily if feasible for the 3 months following sipuleucel-T therapy. All patients continue medical or surgical castration during treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sipuleucel-T and radium 223 combination | Experimental | Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20 Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10 |
|
| sipuleucel-T alone | Active Comparator | Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radium-223 | Drug | 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune Responses to Treatment With Sipuleucel-T (With or Without Radium-223) Measured by Peripheral PA2024 T-cell Proliferation | 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] ). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time | 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. |
Not provided
Inclusion Criteria:
Written informed consent provided prior to initiation of study procedures
Age ≥ 18 years
Histologically documented adenocarcinoma prostate cancer confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen. If prostatic tumor is of mixed histology, > 50% of the tumor must be adenocarcinoma
Bone metastases as manifested by one or more lesions on a bone scan performed within 2 months of screening
Castrate-resistant prostate cancer, in the setting of castrate levels of testosterone (≤ 50 ng/dL), defined as current or historical evidence of disease progression concomitant with surgical castration or androgen deprivation therapy (ADT), as demonstrated by two consecutive rises in PSA OR new lesions on bone scan:
Serum PSA ≥ 2.0 ng/mL
Screening ECOG perf status ≤ 1
Asymptomatic or minimally symptomatic disease (no narcotic analgesic; other analgesics use is allowed)
Prior abiraterone and enzalutamide are permitted, but not required
Concurrent osteoclast-inhibitory therapies (zoledronic acid, denosumab) are permitted if patients have been on a stable dose for at least 1 month
Adequate screening hematologic, renal, and liver function as evidenced by laboratory test results within the following ranges ≤ 28 days prior to registration:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Antonarakis, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Sibley Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33451978 | Result | Marshall CH, Fu W, Wang H, Park JC, DeWeese TL, Tran PT, Song DY, King S, Afful M, Hurrelbrink J, Manogue C, Cotogno P, Moldawer NP, Barata PC, Drake CG, Posadas EM, Armstrong AJ, Sartor O, Antonarakis ES. Randomized Phase II Trial of Sipuleucel-T with or without Radium-223 in Men with Bone-metastatic Castration-resistant Prostate Cancer. Clin Cancer Res. 2021 Mar 15;27(6):1623-1630. doi: 10.1158/1078-0432.CCR-20-4476. Epub 2021 Jan 15. | |
| 35027313 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
One screen failure and one withdrew consent prior to randomization, two participants withdrew prior to receiving treatment
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sipuleucel-T and Radium 223 Combination | Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20 Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10 Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223 Sipuleucel-T: 3 infusions of sipuleucel-T alone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Aug 21, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sipuleucel-T | Biological | 3 infusions of sipuleucel-T alone |
|
|
| Up to 52 weeks |
| Time to Radiographic or Clinical Progression | 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. | Up to 2 years |
| PSA50 Response (at Least a 50% Decline in PSA) | Number of participants with PSA50 response defined as at least a 50% decline in Prostate Specific Antigen (PSA) from baseline value | Up to 2 years |
| Peripheral PAP Specific T-cell Proliferation as Measured by Stimulation Index Over Time | 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 | Up to 52 weeks |
| Peripheral PA2024 Specific T-cell Activation | 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. | Up to 52 weeks |
| Peripheral PAP Specific T-cell Activation | 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. | Up to 52 weeks |
| PA2024 Specific Antibody (IgM) Response | 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. | Up to 52 weeks |
| PA2024 Specific Antibody (IgG) Response | 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. | Up to 52 weeks |
| PAP Specific Antibody (IgG) Response Over Time | 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. | Up to 52 weeks |
| PAP Specific Antibody (IgM) Response | Mean titer of PAP 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. | Up to 52 weeks |
| Sipuleucel-T Product Immune Parameters as Assessed by Number of CD54+ Cells | Mean number of CD54 + cells | Up to 4 weeks |
| Sipuleucel-T Product Immune Parameters as Assessed by CD54+ Upregulation | Mean CD54+ Upregulation of Sipuleucel-T | Up to 4 weeks |
| Sipuleucel-T Product Immune Parameters as Assessed by Total Nucleated Cell Count | Mean number of Total Nucleated Cells | Up to 4 weeks |
| Washington D.C. |
| District of Columbia |
| 20016 |
| United States |
| Tulane Cancer Center | New Orleans | Louisiana | 70112 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21231 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Derived |
| Gongora ABL, Marshall CH, Velho PI, Lopes CDH, Marin JF, Camargo AA, Bastos DA, Antonarakis ES. Extreme Responses to a Combination of DNA-Damaging Therapy and Immunotherapy in CDK12-Altered Metastatic Castration-Resistant Prostate Cancer: A Potential Therapeutic Vulnerability. Clin Genitourin Cancer. 2022 Apr;20(2):183-188. doi: 10.1016/j.clgc.2021.11.015. Epub 2021 Dec 24. No abstract available. |
| FG001 | Sipuleucel-T Alone | Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10 Sipuleucel-T: 3 infusions of sipuleucel-T alone |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sipuleucel-T and Radium 223 Combination | Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20 Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10 Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223 Sipuleucel-T: 3 infusions of sipuleucel-T alone |
| BG001 | Sipuleucel-T Alone | Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10 Sipuleucel-T: 3 infusions of sipuleucel-T alone |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Immune Responses to Treatment With Sipuleucel-T (With or Without Radium-223) Measured by Peripheral PA2024 T-cell Proliferation | 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] ). | Posted | Median | Inter-Quartile Range | fold change | 6 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time | 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. | 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 | Posted | Mean | Inter-Quartile Range | Stimulation Index | Up to 52 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Radiographic or Clinical Progression | 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. | Posted | Median | 95% Confidence Interval | WEEKS | Up to 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | PSA50 Response (at Least a 50% Decline in PSA) | Number of participants with PSA50 response defined as at least a 50% decline in Prostate Specific Antigen (PSA) from baseline value | Posted | Count of Participants | Participants | Up to 2 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Peripheral PAP Specific T-cell Proliferation as Measured by Stimulation Index Over Time | 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 | 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 | Posted | Mean | Inter-Quartile Range | Stimulation Index | Up to 52 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Peripheral PA2024 Specific T-cell Activation | 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. | 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 | Posted | Mean | Inter-Quartile Range | cells per 300,000 PBMCs | Up to 52 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Peripheral PAP Specific T-cell Activation | 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. | 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 | Posted | Mean | Inter-Quartile Range | cells per 300,000 PBMCs | Up to 52 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | PA2024 Specific Antibody (IgM) Response | 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. | 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 | Posted | Mean | Inter-Quartile Range | titer | Up to 52 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | PA2024 Specific Antibody (IgG) Response | 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. | 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 | Posted | Mean | Inter-Quartile Range | titer | Up to 52 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | PAP Specific Antibody (IgG) Response Over Time | 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. | 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 | Posted | Mean | Inter-Quartile Range | titer | Up to 52 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | PAP Specific Antibody (IgM) Response | Mean titer of PAP 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. | 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 | Posted | Mean | Inter-Quartile Range | titer | Up to 52 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Sipuleucel-T Product Immune Parameters as Assessed by Number of CD54+ Cells | Mean number of CD54 + cells | 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 | Posted | Mean | Inter-Quartile Range | cells x 10 ^ 6 | Up to 4 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Sipuleucel-T Product Immune Parameters as Assessed by CD54+ Upregulation | Mean CD54+ Upregulation of Sipuleucel-T | 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 | Posted | Mean | Inter-Quartile Range | cells x 10^6 | Up to 4 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Sipuleucel-T Product Immune Parameters as Assessed by Total Nucleated Cell Count | Mean number of Total Nucleated Cells | 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 | Posted | Mean | Inter-Quartile Range | cells 10^6 | Up to 4 weeks |
|
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sipuleucel-T and Radium 223 Combination | Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20 Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10 Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223 Sipuleucel-T: 3 infusions of sipuleucel-T alone | 0 | 16 | 2 | 16 | 12 | 16 |
| EG001 | Sipuleucel-T Alone | Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10 Sipuleucel-T: 3 infusions of sipuleucel-T alone | 0 | 16 | 1 | 16 | 12 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Flu Like Symptoms | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| White Blood Cell Decreased | Investigations | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Platelet Count Decreased | Investigations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Edema Limbs | General disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Catheter Related Infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emmanuel Antonarakis, MD | Johns Hopkins University | 410-502-8341 | eantona1@jhmi.edu |
| Apr 7, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000615150 | Radium-223 |
| C581106 | radium Ra 223 dichloride |
| C511774 | sipuleucel-T |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|