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This is a randomized, double blind, multi-institutional phase II therapeutic study of Indoximod or placebo after the completion of standard of care sipuleucel-T (Provenge®) in men with asymptomatic or minimally symptomatic metastatic prostate cancer that is castration resistant (hormone refractory). Patients are randomized to receive either twice daily oral Indoximod or placebo for 6 months beginning the day after the third and final sipuleucel-T infusion.
Sipuleucel-T will be administered as standard of care. Oral Indoximod/placebo will be self-administered twice daily for 6 months starting after the last infusion of sipuleucel-T. Patients will be treated for a minimum of 12 weeks of Indoximod/placebo before disease progression can be declared and Indoximod/placebo will not be discontinued for increasing prostate specific antigen (PSA) in the absence of symptomatic clinical progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sipuleucel-T + Oral Indoximod | Experimental | Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg. |
|
| Sipuleucel-T + Placebo | Placebo Comparator | Placebo is identical-looking to Indoximod and provided in the same manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indoximod | Biological | Given twice daily (1200 mg total) by mouth for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune Response to Sipuleucel-T | Assess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo. The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024. Increase in number of ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm. | 14 Weeks from First Leukapheresis |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progression Free Survival at 6 Months | Progression free survival (PFS) is a composite endpoint defined as disease progression in bone or soft tissues, PSA progression, worsening pain, or death. PFS will be measured in months from the time of study enrollment until the date of disease progression. Progression is evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. |
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Inclusion Criteria:
Histologically documented adenocarcinoma of the prostate with metastatic disease as evidenced by soft tissue and/or bony metastases on baseline computed tomography (CT) scan of the abdomen and pelvis and/or bone scan
Castration-resistant based on a current or historical evidence of disease progression despite surgical or medical castration as demonstrated by one or more of the following:
Serum PSA ≥ 2.0 ng/ml at study enrollment
Castration levels of testosterone defined as ≤ 30 ng/dL at study enrollment. Must be at least 3 months from surgical castration or must have received medical castration therapy for at least 3 months and be receiving such therapy at the time of confirmed disease progression
Asymptomatic or minimally symptomatic disease as demonstrated by Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 and no need for opiate pain medications to control pain/symptoms
Age 18 years and old
Adequate bone marrow, renal and hepatic function within 14 days of study enrollment defined as:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shilpa Gupta, M.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Medical Center | Chicago | Illinois | 60612 | United States | ||
| Masonic Cancer Center, University of Minnesota |
One patient withdrew or refused to participate after receiving protocol therapy
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| ID | Title | Description |
|---|---|---|
| FG000 | Sipuleucel-T + Placebo | Placebo is identical-looking to Indoximod and provided in the same manner. Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday). Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth. |
| 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 | Sep 30, 2015 |
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| Sipuleucel-T | Biological | Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday). |
|
|
| Placebo | Other | Given in same manner as Indoximod; 1200 mg per day by mouth. |
|
| 6 Months |
| Objective Response Rate | rate as defined by Prostate Cancer Working Group -2 (PCWG2). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST)(version 1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesion. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | 4 weeks |
| Overall Survival | To evaluate 2 year overall survival | 2 years |
| Quality of Life Scale Results | measured by the performance status with scale of 0-5 0 being 'normal activity' and 5 'being dead' | 6 Months |
| Ratio of Antibodies to PA2024 | Assess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo. The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024. Antibodies to PA2024 is measured by ELISA. The ratio of antibodies to ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm. | 14 Weeks from First Leukapheresis |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| New York Presbyterian/Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| FG001 | Sipuleucel-T + Oral Indoximod | Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg. Indoximod: Given twice daily (1200 mg total) by mouth for 6 months. Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday). |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (Placebo) Arm | Placebo is identical-looking to Indoximod and provided in the same manner. Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday). Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth. |
| BG001 | Treatment | Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg. Indoximod: Given twice daily (1200 mg total) by mouth for 6 months. Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday). |
| 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 |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 Response to Sipuleucel-T | Assess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo. The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024. Increase in number of ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm. | Posted | Geometric Mean | 95% Confidence Interval | Spots per ml | 14 Weeks from First Leukapheresis |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Progression Free Survival at 6 Months | Progression free survival (PFS) is a composite endpoint defined as disease progression in bone or soft tissues, PSA progression, worsening pain, or death. PFS will be measured in months from the time of study enrollment until the date of disease progression. Progression is evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. | Posted | Count of Participants | Participants | 6 Months |
| ||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate | rate as defined by Prostate Cancer Working Group -2 (PCWG2). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST)(version 1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesion. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | Posted | Count of Participants | Participants | 4 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | To evaluate 2 year overall survival | Posted | Count of Participants | Participants | 2 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Quality of Life Scale Results | measured by the performance status with scale of 0-5 0 being 'normal activity' and 5 'being dead' | Posted | Count of Participants | Participants | 6 Months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Ratio of Antibodies to PA2024 | Assess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo. The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024. Antibodies to PA2024 is measured by ELISA. The ratio of antibodies to ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 14 Weeks from First Leukapheresis |
|
28 days
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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 | Sipuleucel-T + Indoximod | Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg. Indoximod: Given twice daily (1200 mg total) by mouth for 6 months. Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday). | 5 | 22 | 2 | 22 | 20 | 22 |
| EG001 | Sipuleucel-T + Placebo | Placebo is identical-looking to Indoximod and provided in the same manner. Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday). Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth. | 6 | 24 | 1 | 24 | 21 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract obstruction | Renal and urinary disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Positive ANA panel 1:320 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymph node pain (bilateral inguinal) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| White blood cell count decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Middle ear effusion | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Blurred vision | Eye disorders | Systematic Assessment |
| ||
| Watering eyes | Eye disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bloating | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Increased appetite | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mouth sores | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal Mucus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Teeth discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| GERD | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| TMJ pain | General disorders | Systematic Assessment |
| ||
| Fatique | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Flu like symptoms | General disorders | Systematic Assessment |
| ||
| Other general disorders -Reflux | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Edema | General disorders | Systematic Assessment |
| ||
| Chest pressure | General disorders | Systematic Assessment |
| ||
| Toe fungal infection | Infections and infestations | Systematic Assessment |
| ||
| Toxoplasma exposure | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| right leg infection | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis infective | Infections and infestations | Systematic Assessment |
| ||
| Papular rash to nose and left neck | Infections and infestations | Systematic Assessment |
| ||
| Left fibula fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Issues with return IV | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Spinal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Bleeding to cather | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Elevated alkaline phosphatase | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Anemia | Investigations | Systematic Assessment |
| ||
| Weight gain | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia, intermittent | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypermagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Buttock pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Memory loss | Nervous system disorders | Systematic Assessment |
| ||
| Nueropathy | Nervous system disorders | Systematic Assessment |
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| Paresthesia | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral motor neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary hesitancy | Renal and urinary disorders | Systematic Assessment |
| ||
| Bladder incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
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| Erectile Dysfunction | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Photosensitivity | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Flushing | Vascular disorders | Systematic Assessment |
| ||
| Hematuria | Vascular disorders | Systematic Assessment |
| ||
| Hot flashes | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Thromoembolic event | Vascular disorders | Systematic Assessment |
| ||
| Other; Tongue Swelling | General disorders | Systematic Assessment |
| ||
| Other; Spinal tenderness | General disorders | Systematic Assessment |
| ||
| Other; Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Other; Muscle cramp | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Other; Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Other; Slight rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Other; Dermatitis Scrotum | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Other; Slight thickening of the skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Infusion related reaction | General disorders | Systematic Assessment |
| ||
| Other; Fatigue | General disorders | Systematic Assessment |
| ||
| ecchymois bilateral arms from leukapheresis access site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Gautam Jha | Masonic Cancer Center, University of Minnesota | 612-624-5373 | jhaxx014@umn.edu |
| Feb 24, 2020 |
| 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 |
|---|---|
| C525396 | 1-methyltryptophan |
| 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 |
|
|
|
|
|
|
|
| Participants |
|
|
|
|
| No Data |
|