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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01169 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| IRB00070691 | Other Identifier | JHM IRB | |
| J15106 | Other Identifier | Johns Hopkins University/Sidney Kimmel Cancer Center | |
| P30CA006973 | U.S. NIH Grant/Contract | View source |
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insufficient clinical response per DSMB
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase II trial studies how well docetaxel works when given with or without ascorbic acid in treating patients with prostate cancer that has spread to other places in the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ascorbic acid (vitamin C) is a water-soluble vitamin that may help inhibit the growth of cancer cells. It is not yet known whether docetaxel works better when given with or without ascorbic acid in treating prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (docetaxel, ascorbic acid) | Experimental | Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. |
|
| Arm B (docetaxel, placebo) | Placebo Comparator | Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic Acid | Dietary Supplement | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participates With a Decline in Prostate-specific Antigen From Their Baseline Measurement | prostate-specific antigen decline will be defined as ≥ 50% from baseline measurement | up to 24 weeks |
| Number of Participants With Adverse Events | Number of participants experiencing fatigue, nausea, bone pain, and anorexia as defined by CTCAE 4.0 | Up to 30 days after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Times Docetaxel Had Dose Reductions | The number of dose reductions and total number of completed cycles will be summarized by study arm. | Up to 24 weeks |
| Number of Serious Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Ascorbic Acid on Docetaxel Exposure | To determine whether ascorbic acid alters docetaxel exposure and compare between treatment arms, pharmacokinetics samples will be collected prior to, during, and after ascorbic acid and docetaxel infusions. | Up to 24 weeks |
| F2-isoprostanes, a Pharmacodynamic Measure of Oxidant Injury in Vivo |
Inclusion Criteria:
Have metastatic castration-resistant prostate cancer (prostate cancer progressing despite castrate levels of testosterone [< 50 ng/dL] using standard measures of progression defined by Prostate Cancer Working Group 2), are chemo-naïve for metastatic castration-resistant prostate cancer (mCRPC); patients must have symptomatic disease or visceral metastases or otherwise be eligible for docetaxel treatment per investigator judgment (e.g. for progression on imaging or rapidly rising PSA despite 2nd line hormonal treatment);
Have a pathological diagnosis of prostate carcinoma
Patients may be receiving continuous hormonal ablation with surgical or medical castration with baseline testosterone < 50 ng/dL
Patient may be receiving bone targeted agents
Have evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and/or Prostate Cancer Working Group 2 (PCWG2) criteria
Have ECOG performance status 0-1
Have an estimated life expectancy > 4 months
Absolute neutrophil count >= 1500/mm^3
Platelets >= 100,000/mm^3
Hemoglobin >= 9 g/dL
Total bilirubin =< 1.0 upper limit of normal (ULN)
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN
Creatinine =< 1.6 mg/dl (for patients with > 1.6 mg/dl, calculated or measured creatinine clearance must be >= 55 mL/minute [Cockcroft-Gault])
Men of reproductive potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception that has an expected failure rate of < 1% during and for 30 days after discontinuation of study treatment
Have the ability to understand, and have given written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Exclusion Criteria:
Have had known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for CNS involvement for at least one week prior to trial treatment; patients with primary brain tumors are not eligible; however, as patients are completing abiraterone therapy, they will be allowed to continue up to 10 mg/day of prednisone
Have had prior chemotherapy for metastatic disease in castration-resistant prostate cancer (prior chemotherapy for hormone-sensitive disease, more than twelve months prior to registration, is acceptable)
Have had had surgery within four weeks of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement
Have had palliative radiation or biological cancer therapy within 2 weeks prior to the first dose of study drug
Have received other investigational drugs within 28 days prior to enrollment
Is expected to require any other form of systemic or localized antineoplastic therapy while on study
Patients who require frequent (several times a day) monitoring of their blood glucose or patients who have recently been hospitalized for glucose control
Are being treated with anticoagulation therapy (aspirin and nonsteroidal anti-inflammatory drugs [NSAIDS] are allowed)
The subject requires concomitant treatment with the following inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4):
Have uncontrolled intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Has glucose-6-phosphate dehydrogenase (G6PD) deficiency
Have end stage renal disease
Has history of calcium oxalate stones
Has history of iron overload
Have a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
Have a know active uncontrolled hepatitis B, or hepatitis C infection
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| Name | Affiliation | Role |
|---|---|---|
| Channing Paller, MD | Johns Hopkins University/Sidney Kimmel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States | ||
| Anne Arundel Health System, Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39076107 | Derived | Paller CJ, Zahurak ML, Mandl A, Metri NA, Lalji A, Heath E, Kelly WK, Hoimes C, Barata P, Taksey J, Garrison DA, Patra K, Milne GL, Anders NM, Nauroth JM, Durham JN, Marshall CH, Markowski MC, Eisenberger MA, Antonarakis ES, Carducci MA, Denmeade SR, Levine M. High-Dose Intravenous Vitamin C Combined with Docetaxel in Men with Metastatic Castration-Resistant Prostate Cancer: A Randomized Placebo-Controlled Phase II Trial. Cancer Res Commun. 2024 Aug 1;4(8):2174-2182. doi: 10.1158/2767-9764.CRC-24-0225. |
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12 subjects were Screen fails
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Docetaxel, Ascorbic Acid) | Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Ascorbic Acid: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| 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 | Oct 19, 2021 |
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| Docetaxel | Drug | Given IV |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Pharmacological Study | Other | Correlative studies |
|
| Placebo | Other | Given IV |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
Number of serious adverse events of all types as defined by Common Terminology Criteria for Adverse Events 4.0.
A serious adverse event is an undesirable sign, symptom, or medical condition that:
| Up to 30 days after last dose of study drug |
| Number of Participates Experiencing Serious Adverse Events (SAE) | Number of serious adverse events defined as grade 3 or higher (fatigue, nausea, bone pain, and anorexia) in participates as defined by CTCAE 4.0 | Up to 24 weeks |
| Change in Quality of Life (QoL) as Measured by the FACT-P Questionnaire | The (FACT-P) is made up of 39 question, with the total score ranging between 0 and 156 with 0 being the best and 156 as the worst. | Up to course 6 of therapy (18 weeks) |
| Radiographic Progression Free Survival (rPFS) | To determine the rPFS of participates that receive at least one dose of ascorbic acid compared to those who received placebo | Up to 3 years |
Correlative analyses will assess the association between ascorbic acid and lipid peroxidation (F2-isoprostanes) in the two study arms, globally, and over time. Comparisons of ascorbic acid and F2-isoprostanes by study arm at cycle 1, cycle 2, cycle 4 and cycle 6, accounting for baseline measures obtained from the same patient, will be made by taking differences between post baseline and baseline values and comparing these differences between arms of the study with t-tests. Regression will also be used to assess the association between F2-isoprostane and ascorbic acid at cycle 4 and at cycle 6. |
| Up to course 6 (18 weeks) |
| Peak and Trough Ascorbic Acid Levels | Up to 24 weeks |
| Annapolis |
| Maryland |
| 21401 |
| United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University Hospitals of Cleveland Seidman Cancer Center | Cleveland | Ohio | 44106 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| FG001 | Arm B (Docetaxel, Placebo) | Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given IV Quality-of-Life Assessment: Ancillary studies |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Docetaxel, Ascorbic Acid) | Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Ascorbic Acid: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| BG001 | Arm B (Docetaxel, Placebo) | Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given IV Quality-of-Life Assessment: Ancillary studies |
| 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, 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 | Number of Participates With a Decline in Prostate-specific Antigen From Their Baseline Measurement | prostate-specific antigen decline will be defined as ≥ 50% from baseline measurement | Posted | Count of Participants | Participants | up to 24 weeks |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events | Number of participants experiencing fatigue, nausea, bone pain, and anorexia as defined by CTCAE 4.0 | Posted | Count of Participants | Participants | Up to 30 days after the last dose of study drug |
|
| |||||||||||||||||||||||||||||||
| Secondary | Average Number of Times Docetaxel Had Dose Reductions | The number of dose reductions and total number of completed cycles will be summarized by study arm. | Posted | Mean | Full Range | dose reductions | Up to 24 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Serious Adverse Events | Number of serious adverse events of all types as defined by Common Terminology Criteria for Adverse Events 4.0. A serious adverse event is an undesirable sign, symptom, or medical condition that:
| Posted | Number | events | Up to 30 days after last dose of study drug |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participates Experiencing Serious Adverse Events (SAE) | Number of serious adverse events defined as grade 3 or higher (fatigue, nausea, bone pain, and anorexia) in participates as defined by CTCAE 4.0 | Posted | Count of Participants | Participants | Up to 24 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life (QoL) as Measured by the FACT-P Questionnaire | The (FACT-P) is made up of 39 question, with the total score ranging between 0 and 156 with 0 being the best and 156 as the worst. | Posted | Mean | 95% Confidence Interval | score on a scale | Up to course 6 of therapy (18 weeks) |
| |||||||||||||||||||||||||||||||
| Secondary | Radiographic Progression Free Survival (rPFS) | To determine the rPFS of participates that receive at least one dose of ascorbic acid compared to those who received placebo | Posted | Median | 95% Confidence Interval | months | Up to 3 years |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Effect of Ascorbic Acid on Docetaxel Exposure | To determine whether ascorbic acid alters docetaxel exposure and compare between treatment arms, pharmacokinetics samples will be collected prior to, during, and after ascorbic acid and docetaxel infusions. | Not Posted | Up to 24 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | F2-isoprostanes, a Pharmacodynamic Measure of Oxidant Injury in Vivo | Correlative analyses will assess the association between ascorbic acid and lipid peroxidation (F2-isoprostanes) in the two study arms, globally, and over time. Comparisons of ascorbic acid and F2-isoprostanes by study arm at cycle 1, cycle 2, cycle 4 and cycle 6, accounting for baseline measures obtained from the same patient, will be made by taking differences between post baseline and baseline values and comparing these differences between arms of the study with t-tests. Regression will also be used to assess the association between F2-isoprostane and ascorbic acid at cycle 4 and at cycle 6. | Not Posted | Up to course 6 (18 weeks) | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Peak and Trough Ascorbic Acid Levels | Not Posted | Up to 24 weeks | Participants |
Up to 30 days after the last dose of study drug
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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 A (Docetaxel, Ascorbic Acid) | Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Ascorbic Acid: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Quality-of-Life Assessment: Ancillary studies | 0 | 34 | 8 | 34 | 34 | 34 |
| EG001 | Arm B (Docetaxel, Placebo) | Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given IV Quality-of-Life Assessment: Ancillary studies | 0 | 16 | 3 | 16 | 16 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Flank Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hip pain |
| |
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Lung infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Myocardialinfarction | Cardiac disorders | Systematic Assessment |
| ||
| Investigations - Other specify | Investigations | Systematic Assessment | Depressed level of consciousness |
| |
| Investigations - Other specify | Investigations | Systematic Assessment | Neutropenia |
| |
| Investigations - Other specify | Investigations | Systematic Assessment | COLITIS |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Alopecia | General disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Aneroxia | General disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Blurred vision | Eye disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| chills | General disorders | Systematic Assessment |
| ||
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
| ||
| Cold symptoms | General disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Decreased Appetite | General disorders | Systematic Assessment |
| ||
| Dehydratin | General disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | General disorders | Systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Edema | Vascular disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flushing | Vascular disorders | Systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hot flashes | Vascular disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HypoKalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Light Headedness | General disorders | Systematic Assessment |
| ||
| Lymphocyte Count Decreased | Investigations | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nail changes | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neuropathy sensory | Nervous system disorders | Systematic Assessment |
| ||
| Neutropenia | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Nocturia | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Taste Changes | General disorders | Systematic Assessment |
| ||
| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| UTI Infection | Infections and infestations | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Watering Eyes | Eye disorders | Systematic Assessment |
| ||
| Weight Gain | Investigations | Systematic Assessment |
| ||
| Weight Loss | Investigations | Systematic Assessment |
| ||
| White Blood Cell Count Decreased | Investigations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Channing Paller Associate Professor Urologic Oncology | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 4109558239 | cpaller1@jhmi.edu |
| Jul 8, 2022 |
| 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 |
|---|---|
| D001205 | Ascorbic Acid |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| 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 |
|
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