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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CALGB-99811 | |||
| CDR0000068632 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin or leuprolide may stop the adrenal glands from producing androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, hormone therapy, and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying giving chemotherapy together with hormone therapy and radiation therapy in treating patients with locally advanced prostate cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 1 hour once weekly; oral estramustine three times a day, five days a week; and carboplatin IV over 1 hour once monthly. Treatment repeats every 4 weeks for 4 courses.
Patients also receive gonadotropin-releasing hormonal therapy comprising either goserelin subcutaneously or leuprolide intramuscularly once monthly. Treatment repeats every 4 weeks for 6 courses.
After the completion of chemotherapy, patients undergo radiotherapy once daily on weeks 17-24.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neo-Adj ChemoTx + ablation prior to RT | Experimental | Patients with localized high-risk prostate cancer were treated with 4 cycles (16 weeks) of continuous weekly paclitaxel at 80 mg/m^2 intravenously with estramustine at 280 mg orally 3 times a day for 5 days a week and carboplatin (area under the curve of 6) on Day 1 of every cycle followed by 3-dimensional conformal or intensity-modulated radiotherapy (total dose of 77.4 gray [Gy] in 1.8-Gy fractions). All patients received androgen deprivation therapy with either goserelin acetate at 3.6 mg subcutaneously or leuprolide acetate at 7.5 mg intramuscularly monthly for 6 months starting at Day 1 of therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | AUC=6 week one of each 4 week cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Patients were evaluated for acute toxicities defined as grade 3 or greater cardiovascular (including venous thrombosis), gastrointestinal, or genitourinary toxicity occurring during the period starting from treatment initiation until 90 days or less after the completion of radiotherapy. The same toxicity measures were monitored at >90 days after the completion of radiotherapy. | 90 days and 1 year post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Prostate-specific Antigen Failure | PSA progression was defined in 2 ways. The CALGB PSA progression was defined as 2 consecutive rises in PSA with a rise of at least 0.2 ng/mL and above 1.0 ng/mL after radiation therapy; the date of PSA failure is taken as the midpoint between the last PSA before the rise and the first of the 2 PSAs that documented the rise. In addition, PSA progression was used according to the American Society for Therapeutic Radiology and Oncology 1996 (ASTRO) criteria and defined as 3 consecutive rises in PSA after radiation therapy. The date of PSA failure was taken as the midpoint between the time of the lowest PSA measure after irradiation and the first of the 3 consecutive rises. |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate with one of the following prognostic factors:
No pelvic lymph node disease requiring pelvic radiotherapy
No metastatic disease by bone scan, CT scan, or MRI
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| William K. Kelly, DO | Yale University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18989865 | Result | Kelly WK, Halabi S, Elfiky A, Ou SS, Bogart J, Zelefsky M, Small E; Cancer Leukemia Group B. Multicenter phase 2 study of neoadjuvant paclitaxel, estramustine phosphate, and carboplatin plus androgen deprivation before radiation therapy in patients with unfavorable-risk localized prostate cancer: results of Cancer and Leukemia Group B 99811. Cancer. 2008 Dec 1;113(11):3137-45. doi: 10.1002/cncr.23910. |
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Of these 34 patients, 4 patients did not have radiotherapy, 2 patients were ineligible, and 1 case had limited follow-up data after radiotherapy. Final analyses were performed on 27 patients.
Between May 15, 2001 and June 30, 2006, a total of 34 patients were enrolled in the study. All CALGB institutions, comprised of 29 major university medical centers and their affiliates, were approved to participate in this study, of which 10 CALGB sites enrolled patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neo-Adj ChemoTx + Ablation Prior to RT | Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| estramustine |
| Drug |
2 tablets tid PO 5 of 7 days per week each 4 week cycle |
|
| paclitaxel | Drug | 80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle |
|
| radiation therapy | Radiation | 77.4 Gy in 1.8 Gy fractions |
|
| leuprolide or goserelin acetate | Drug | 7.5 mg IM injection once every 4 weeks for 6 months |
|
| PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years). |
| Progression-free Survival (PFS) | PFS was defined as the time between treatment initiation and the date of disease progression (PSA, bone, tumor) or death, whichever occurred first. PSA progression is defined as 2 consecutive rising PSAs (a rise of at least 0.2 ng/mL) above 1.0 ng/mL. | registration to progression, up to 5.5 years from registration |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5001 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Veterans Affairs Medical Center - Baltimore | Baltimore | Maryland | 21201 | United States |
| UMASS Memorial Cancer Center - University Campus | Worcester | Massachusetts | 01655 | United States |
| Saint Luke's Hospital | Chesterfield | Missouri | 63017 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Oswego Hospital | Oswego | New York | 13126 | United States |
| CCOP - Hematology-Oncology Associates of Central New York | Syracuse | New York | 13057 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Veterans Affairs Medical Center - Syracuse | Syracuse | New York | 13210 | United States |
| Community General Hospital of Greater Syracuse | Syracuse | New York | 13215 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Wayne Radiation Oncology | Goldsboro | North Carolina | 27534 | United States |
| Lenoir Memorial Cancer Center | Kinston | North Carolina | 28501 | United States |
| Wilson Medical Center | Wilson | North Carolina | 27893-3428 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| Roper St. Francis Cancer Center at Roper Hospital | Charleston | South Carolina | 29401 | United States |
| Bon Secours St. Francis Health System | Greenville | South Carolina | 29601 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Neo-Adj ChemoTx + Ablation Prior to RT | Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Toxicity | Patients were evaluated for acute toxicities defined as grade 3 or greater cardiovascular (including venous thrombosis), gastrointestinal, or genitourinary toxicity occurring during the period starting from treatment initiation until 90 days or less after the completion of radiotherapy. The same toxicity measures were monitored at >90 days after the completion of radiotherapy. | Final analyses were performed on all 27 eligible patients. | Posted | Number | Events | 90 days and 1 year post treatment |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Prostate-specific Antigen Failure | PSA progression was defined in 2 ways. The CALGB PSA progression was defined as 2 consecutive rises in PSA with a rise of at least 0.2 ng/mL and above 1.0 ng/mL after radiation therapy; the date of PSA failure is taken as the midpoint between the last PSA before the rise and the first of the 2 PSAs that documented the rise. In addition, PSA progression was used according to the American Society for Therapeutic Radiology and Oncology 1996 (ASTRO) criteria and defined as 3 consecutive rises in PSA after radiation therapy. The date of PSA failure was taken as the midpoint between the time of the lowest PSA measure after irradiation and the first of the 3 consecutive rises. | All 27 evaluable patients were used in this analysis. | Posted | Median | 95% Confidence Interval | months | PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years). |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time between treatment initiation and the date of disease progression (PSA, bone, tumor) or death, whichever occurred first. PSA progression is defined as 2 consecutive rising PSAs (a rise of at least 0.2 ng/mL) above 1.0 ng/mL. | All 27 evaluable patients were used in this analysis | Posted | Median | 95% Confidence Interval | months | registration to progression, up to 5.5 years from registration |
|
|
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All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
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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 | Neo-Adj ChemoTx + Ablation Prior to RT | Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer. | 0 | 29 | 29 | 29 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Transfusion: pRBCs | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Edema | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA 10 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 10 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 10 | Systematic Assessment |
| |
| Endocrine disorder | Endocrine disorders | MedDRA 10 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 10 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 10 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 10 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Gastric hemorrhage | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Intra-abdominal hemorrhage | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Rectal bleeding/hematochezia | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 10 | Systematic Assessment |
| |
| General symptom | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Localized edema | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Radiation-Other(Specify,_____) | General disorders | MedDRA 10 | Systematic Assessment | Swelling |
|
| Catheter related infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Urethral infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | MedDRA 10 | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | MedDRA 10 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Coagulopathy | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Creatine phosphokinase increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Forced expiratory volume decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Serum cholesterol increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Blood uric acid increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum calcium increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum sodium increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum triglycerides increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Dysuria (painful urination) | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Hematuria (in the absence of vaginal bleeding) | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Ureteric perforation | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 10 | Systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | MedDRA 10 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 10 | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA 10 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wm. Kevin Kelly, DO | Department of Medicine, Memorial Sloan-Kettering Cancer Center | kellyw@mskcc.org |
| 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 |
|---|---|
| D016190 | Carboplatin |
| D004961 | Estramustine |
| D017239 | Paclitaxel |
| D011878 | Radiotherapy |
| D016729 | Leuprolide |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
|
|