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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00425 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 05190 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well hormone therapy and intensity-modulated radiation therapy work in treating patients with prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Anti-hormone therapy using goserelin, leuprolide acetate, or bicalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving hormone therapy and intensity-modulated radiation therapy may work better in treating patients with prostate cancer.
PRIMARY OBJECTIVES:
I. To evaluate the time to prostate-specific antigen (PSA) relapse in patients with oligometastatic (=< 5 lesions) hormone-sensitive prostate cancer treated with 36 weeks of androgen deprivation therapy and localized radiotherapy to all known tumor sites.
II. To assess the prostate-specific-antigen (PSA) and objective response rate to treatment with 36 weeks of androgen deprivation and localized radiotherapy in patients with oligometastatic hormone-sensitive prostate cancer.
III. To assess the toxicity of 36 weeks of androgen deprivation and localized radiation therapy to oligometastases in patients with oligometastatic hormone-sensitive prostate cancer.
IV. In appropriate situations evaluate the feasibility and toxicities of using helical tomotherapy image-guided intensity-modulated radiation therapy (IMRT) to treat oligometastatic sites.
OUTLINE:
ANDROGEN DEPRIVATION THERAPY (ADT): Patients not currently on ADT receive goserelin acetate subcutaneously (SC) or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide orally (PO) once daily (QD). Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.
RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
After completion of study treatment, patients are followed up every 4 weeks for 2 years, then every 3 months after year 2, and then every 6 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (androgen therapy, radiation therapy) | Experimental | ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicalutamide | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Prostate-specific Antigen (PSA) Relapse | Time from the date of the last dose of bicalutamide or the last day of radiation therapy (whichever comes later) until the date criteria are met for PSA relapse. PSA relapse after completion of initial 36 weeks of androgen deprivation therapy is defined as an increase in PSA value to above pre-therapy level, or to > 10, whichever is smaller. For example, a patient with pre-treatment PSA level of 40 will resume androgen deprivation therapy when PSA level is > 10, while a patient with pre-treatment PSA level of 3 will resume androgen deprivation therapy when PSA level is > 3. | End-of-therapy until PSA reached pre-treatment level or 10 (whichever was lower) |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Who Achieved PSA Nadir of < 0.2 at 36 Weeks. | Number of Patients who achieved PSA nadir of < 0.2 at 36 weeks. | During the time period between on-study PSA to off-study PSA, up to 36 weeks. |
| Rate of Treatment Failure (no PSA Threshold Below 4 ng/dl, or no PSA Below Baseline Level Before LHRH Treatment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cy A Stein | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| City of Hope South Pasadena |
Not provided
The first patient was consented on July 18, 2006. The last eligible patient was consented on August 25, 2010. Patients were recruited at City of Hope National Medical Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Androgen Therapy, Radiation Therapy) | ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection |
| 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 | Jun 14, 2019 |
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| Goserelin Acetate | Drug | Given SC |
|
|
| Intensity-Modulated Radiation Therapy | Radiation | Undergo IMRT |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Leuprolide Acetate | Drug | Given via injection |
|
|
Treatment failures: Count and percent of patients NOT reaching PSA concentration in serum either below 4 ng/dl or below baseline before LHRH treatment . |
| Off-treatment PSA measurement date minus on-study PSA measurement date, up to 36 weeks. |
| Length of Follow-up | Length of follow-up in weeks to off-study date. Patients are treated for 36 weeks (+/- 2 weeks) with androgen deprivation therapy. Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 264.8 weeks (61.4 months; 5.1 years). Patients will remain off-treatment until they meet the criteria for re-treatment with androgen deprivation therapy, whereupon they will be taken off of the protocol. After patients are taken off protocol, we will do a chart review for long-term outcomes. | Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 61.4 months |
| Count of Patients Remaining Off of Therapy | Patients who remained off of therapy, in remission, out of the number of patients with metastases limited to pelvic lymph nodes. | after 36 week LHRH treatment window. |
| Follow-up of the 8 Patients With Metastases Limited to Pelvic Lymph Nodes. | Length of follow-up of the 8 patients with metastases limited to pelvic lymph nodes, months. Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months. | Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months. |
| CR Without ADT in Patients With Metastases Limited to Pelvic Lymph Nodes. | Number of patients remaining in complete remission without androgen deprivation therapy in patients with metastases limited to pelvic lymph nodes. | after 36 weeks of LHRH therapy. |
| South Pasadena |
| California |
| 91030 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Androgen Therapy, Radiation Therapy) | ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection |
| 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 | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | City of Hope National Medical Center, Duarte, CA USA | Count of Participants | Participants |
| |||||||||||||||||||
| Baseline Prostate Specific Antigen (PSA) | The number of patients reaching a nadir of PSA < 0.2 will be reported in the results. | Median | Full Range | ng/ml |
| ||||||||||||||||||
| Metastases limited to pelvic lymph nodes | Count of patients with metastases limited to pelvic lymph nodes. This baseline is referenced in the results section. | 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 | Time to Prostate-specific Antigen (PSA) Relapse | Time from the date of the last dose of bicalutamide or the last day of radiation therapy (whichever comes later) until the date criteria are met for PSA relapse. PSA relapse after completion of initial 36 weeks of androgen deprivation therapy is defined as an increase in PSA value to above pre-therapy level, or to > 10, whichever is smaller. For example, a patient with pre-treatment PSA level of 40 will resume androgen deprivation therapy when PSA level is > 10, while a patient with pre-treatment PSA level of 3 will resume androgen deprivation therapy when PSA level is > 3. | Metastatic prostate cancer patients treated with androgen deprivation. | Posted | Median | 95% Confidence Interval | month | End-of-therapy until PSA reached pre-treatment level or 10 (whichever was lower) |
|
|
| |||||||||||||||||||||||||
| Secondary | Patients Who Achieved PSA Nadir of < 0.2 at 36 Weeks. | Number of Patients who achieved PSA nadir of < 0.2 at 36 weeks. | Patients who achieved PSA nadir of < 0.2 at 36 weeks. | Posted | Count of Participants | Participants | No | During the time period between on-study PSA to off-study PSA, up to 36 weeks. |
|
| ||||||||||||||||||||||||||
| Secondary | Rate of Treatment Failure (no PSA Threshold Below 4 ng/dl, or no PSA Below Baseline Level Before LHRH Treatment). | Treatment failures: Count and percent of patients NOT reaching PSA concentration in serum either below 4 ng/dl or below baseline before LHRH treatment . | Metastatic prostate cancer patients treated with androgen deprivation therapy. | Posted | Count of Participants | Participants | Off-treatment PSA measurement date minus on-study PSA measurement date, up to 36 weeks. |
|
| |||||||||||||||||||||||||||
| Secondary | Length of Follow-up | Length of follow-up in weeks to off-study date. Patients are treated for 36 weeks (+/- 2 weeks) with androgen deprivation therapy. Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 264.8 weeks (61.4 months; 5.1 years). Patients will remain off-treatment until they meet the criteria for re-treatment with androgen deprivation therapy, whereupon they will be taken off of the protocol. After patients are taken off protocol, we will do a chart review for long-term outcomes. | Patients with hormone sensitive prostate cancer | Posted | Median | Full Range | week | Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 61.4 months |
| |||||||||||||||||||||||||||
| Secondary | Count of Patients Remaining Off of Therapy | Patients who remained off of therapy, in remission, out of the number of patients with metastases limited to pelvic lymph nodes. | Patients with metastases limited to pelvic lymph nodes | Posted | Count of Participants | Participants | after 36 week LHRH treatment window. |
|
| |||||||||||||||||||||||||||
| Secondary | Follow-up of the 8 Patients With Metastases Limited to Pelvic Lymph Nodes. | Length of follow-up of the 8 patients with metastases limited to pelvic lymph nodes, months. Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months. | Patients with metastases limited to pelvic lymph nodes. | Posted | Median | Full Range | month | Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months. |
| |||||||||||||||||||||||||||
| Secondary | CR Without ADT in Patients With Metastases Limited to Pelvic Lymph Nodes. | Number of patients remaining in complete remission without androgen deprivation therapy in patients with metastases limited to pelvic lymph nodes. | Patients with metastases limited to pelvic lymph nodes. | Posted | Count of Participants | Participants | after 36 weeks of LHRH therapy. |
|
|
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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 | Treatment (Androgen Therapy, Radiation Therapy) | ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection | 1 | 29 | 28 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 10012727 -- Diarrhea | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10010300 -- Confusion | Psychiatric disorders | meddra10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 10019483 -- Hemoglobin decreased | Blood and lymphatic system disorders | meddra10.0 | Systematic Assessment |
| |
| 10019483 -- Hemoglobin decreased | Blood and lymphatic system disorders | meddra9.0 | Systematic Assessment |
| |
| 10003658 -- Atrial fibrillation | Cardiac disorders | meddra10.0 | Systematic Assessment |
| |
| 10003668 -- Atrial tachycardia | Cardiac disorders | meddra10.0 | Systematic Assessment |
| |
| 10040741 -- Sinus bradycardia | Cardiac disorders | meddra10.0 | Systematic Assessment |
| |
| 10019246 -- Hearing loss | Ear and labyrinth disorders | meddra10.0 | Systematic Assessment |
| |
| 10014695 -- Endocrine disorder | Endocrine disorders | meddra10.0 | Systematic Assessment |
| |
| 10000081 -- Abdominal pain | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10010774 -- Constipation | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10012727 -- Diarrhea | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10013950 -- Dysphagia | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10015461 -- Esophagitis | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10016766 -- Flatulence | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10017944 -- Gastrointestinal disorder | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10018286 -- Gingival pain | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10019611 -- Hemorrhoids | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10028813 -- Nausea | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10036774 -- Proctitis | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10036787 -- Proctoscopy abnormal | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10038064 -- Rectal hemorrhage | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10038072 -- Rectal pain | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10047700 -- Vomiting | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10056848 -- Ear, nose and throat examination abnormal | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10065709 -- Rectal necrosis | Gastrointestinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10012727 -- Diarrhea | Gastrointestinal disorders | meddra9.0 | Systematic Assessment |
| |
| 10028813 -- Nausea | Gastrointestinal disorders | meddra9.0 | Systematic Assessment |
| |
| 10008479 -- Chest pain | General disorders and administration site conditions | meddra10.0 | Systematic Assessment |
| |
| 10016256 -- Fatigue | General disorders and administration site conditions | meddra10.0 | Systematic Assessment |
| |
| 10016558 -- Fever | General disorders and administration site conditions | meddra10.0 | Systematic Assessment |
| |
| 10033371 -- Pain | General disorders and administration site conditions | meddra10.0 | Systematic Assessment |
| |
| 10050068 -- Edema limbs | General disorders and administration site conditions | meddra10.0 | Systematic Assessment |
| |
| 90004082 -- Pain | General disorders and administration site conditions | meddra10.0 | Systematic Assessment |
| |
| 10008531 -- Chills | General disorders and administration site conditions | meddra9.0 | Systematic Assessment |
| |
| 10016558 -- Fever | General disorders and administration site conditions | meddra9.0 | Systematic Assessment |
| |
| 90004082 -- Pain | General disorders and administration site conditions | meddra9.0 | Systematic Assessment |
| |
| 10020751 -- Hypersensitivity | Immune system disorders | meddra10.0 | Systematic Assessment |
| |
| 10021789 -- Infection | Infections and infestations | meddra10.0 | Systematic Assessment |
| |
| 90031098 -- Upper respiratory infection | Infections and infestations | meddra10.0 | Systematic Assessment |
| |
| 90031102 -- Urinary tract infection | Infections and infestations | meddra10.0 | Systematic Assessment |
| |
| 10061103 -- Dermatitis radiation | Injury, poisoning and procedural complications | meddra10.0 | Systematic Assessment |
| |
| 10065892 -- Small intestinal anastomotic leak | Injury, poisoning and procedural complications | meddra10.0 | Systematic Assessment |
| |
| 10061103 -- Dermatitis radiation | Injury, poisoning and procedural complications | meddra9.0 | Systematic Assessment |
| |
| 10001551 -- Alanine aminotransferase increased | Investigations | meddra10.0 | Systematic Assessment |
| |
| 10001675 -- Alkaline phosphatase increased | Investigations | meddra10.0 | Systematic Assessment |
| |
| 10003481 -- Aspartate aminotransferase increased | Investigations | meddra10.0 | Systematic Assessment |
| |
| 10011349 -- Creatine phosphokinase increased | Investigations | meddra10.0 | Systematic Assessment |
| |
| 10011368 -- Creatinine increased | Investigations | meddra10.0 | Systematic Assessment |
| |
| 10025256 -- Lymphocyte count decreased | Investigations | meddra10.0 | Systematic Assessment |
| |
| 10029366 -- Neutrophil count decreased | Investigations | meddra10.0 | Systematic Assessment |
| |
| 10035528 -- Platelet count decreased | Investigations | meddra10.0 | Systematic Assessment |
| |
| 10040190 -- Serum cholesterol increased | Investigations | meddra10.0 | Systematic Assessment |
| |
| 10047896 -- Weight gain | Investigations | meddra10.0 | Systematic Assessment |
| |
| 10048552 -- Leukocyte count decreased | Investigations | meddra10.0 | Systematic Assessment |
| |
| 10024384 -- Leukopenia | Investigations | meddra9.0 | Systematic Assessment |
| |
| 10025327 -- Lymphopenia | Investigations | meddra9.0 | Systematic Assessment |
| |
| 10035528 -- Platelet count decreased | Investigations | meddra9.0 | Systematic Assessment |
| |
| 10002646 -- Anorexia | Metabolism and nutrition disorders | meddra10.0 | Systematic Assessment |
| |
| 10005557 -- Blood glucose increased | Metabolism and nutrition disorders | meddra10.0 | Systematic Assessment |
| |
| 10012174 -- Dehydration | Metabolism and nutrition disorders | meddra10.0 | Systematic Assessment |
| |
| 10040123 -- Serum albumin decreased | Metabolism and nutrition disorders | meddra10.0 | Systematic Assessment |
| |
| 10040175 -- Serum calcium increased | Metabolism and nutrition disorders | meddra10.0 | Systematic Assessment |
| |
| 10040268 -- Serum glucose decreased | Metabolism and nutrition disorders | meddra10.0 | Systematic Assessment |
| |
| 10040336 -- Serum magnesium decreased | Metabolism and nutrition disorders | meddra10.0 | Systematic Assessment |
| |
| 10040378 -- Serum potassium decreased | Metabolism and nutrition disorders | meddra10.0 | Systematic Assessment |
| |
| 10040379 -- Serum potassium increased | Metabolism and nutrition disorders | meddra10.0 | Systematic Assessment |
| |
| 10040405 -- Serum sodium increased | Metabolism and nutrition disorders | meddra10.0 | Systematic Assessment |
| |
| 10040424 -- Serum triglycerides increased | Metabolism and nutrition disorders | meddra10.0 | Systematic Assessment |
| |
| 10054863 -- Serum sodium decreased | Metabolism and nutrition disorders | meddra10.0 | Systematic Assessment |
| |
| 10021018 -- Hypokalemia | Metabolism and nutrition disorders | meddra9.0 | Systematic Assessment |
| |
| 10003246 -- Arthritis | Musculoskeletal and connective tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10003988 -- Back pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10006002 -- Bone pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10023222 -- Joint pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10028411 -- Myalgia | Musculoskeletal and connective tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10028836 -- Neck pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10031282 -- Osteoporosis | Musculoskeletal and connective tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10033425 -- Pain in extremity | Musculoskeletal and connective tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10013573 -- Dizziness | Nervous system disorders | meddra10.0 | Systematic Assessment |
| |
| 10019211 -- Headache | Nervous system disorders | meddra10.0 | Systematic Assessment |
| |
| 10029298 -- Neurological disorder NOS | Nervous system disorders | meddra10.0 | Systematic Assessment |
| |
| 10034620 -- Peripheral sensory neuropathy | Nervous system disorders | meddra10.0 | Systematic Assessment |
| |
| 10002855 -- Anxiety | Psychiatric disorders | meddra10.0 | Systematic Assessment |
| |
| 10012378 -- Depression | Psychiatric disorders | meddra10.0 | Systematic Assessment |
| |
| 10022437 -- Insomnia | Psychiatric disorders | meddra10.0 | Systematic Assessment |
| |
| 10024419 -- Libido decreased | Psychiatric disorders | meddra10.0 | Systematic Assessment |
| |
| 10011781 -- Cystitis | Renal and urinary disorders | meddra10.0 | Systematic Assessment |
| |
| 10019591 -- Hemorrhage urinary tract | Renal and urinary disorders | meddra10.0 | Systematic Assessment |
| |
| 10037020 -- Protein urine positive | Renal and urinary disorders | meddra10.0 | Systematic Assessment |
| |
| 10038435 -- Renal failure | Renal and urinary disorders | meddra10.0 | Systematic Assessment |
| |
| 10046461 -- Urethral pain | Renal and urinary disorders | meddra10.0 | Systematic Assessment |
| |
| 10046539 -- Urinary frequency | Renal and urinary disorders | meddra10.0 | Systematic Assessment |
| |
| 10046543 -- Urinary incontinence | Renal and urinary disorders | meddra10.0 | Systematic Assessment |
| |
| 10046555 -- Urinary retention | Renal and urinary disorders | meddra10.0 | Systematic Assessment |
| |
| 10046694 -- Urogenital disorder | Renal and urinary disorders | meddra10.0 | Systematic Assessment |
| |
| 10046694 -- Urogenital disorder | Renal and urinary disorders | meddra9.0 | Systematic Assessment |
| |
| 10034310 -- Penile pain | Reproductive system and breast disorders | meddra10.0 | Systematic Assessment |
| |
| 10036968 -- Prostatic pain | Reproductive system and breast disorders | meddra10.0 | Systematic Assessment |
| |
| 10061461 -- Erectile dysfunction | Reproductive system and breast disorders | meddra10.0 | Systematic Assessment |
| |
| 10018801 -- Gynecomastia | Reproductive system and breast disorders | meddra9.0 | Systematic Assessment |
| |
| 10011224 -- Cough | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10013963 -- Dyspnea | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10034844 -- Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10035598 -- Pleural effusion | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10047681 -- Voice alteration | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Systematic Assessment |
| |
| 10001760 -- Alopecia | Skin and subcutaneous tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10013786 -- Dry skin | Skin and subcutaneous tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10037087 -- Pruritus | Skin and subcutaneous tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10037853 -- Rash desquamating | Skin and subcutaneous tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10040831 -- Skin disorder | Skin and subcutaneous tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10040865 -- Skin hyperpigmentation | Skin and subcutaneous tissue disorders | meddra10.0 | Systematic Assessment |
| |
| 10020407 -- Hot flashes | Vascular disorders | meddra10.0 | Systematic Assessment |
| |
| 10020772 -- Hypertension | Vascular disorders | meddra10.0 | Systematic Assessment |
| |
| 10021097 -- Hypotension | Vascular disorders | meddra10.0 | Systematic Assessment |
| |
| 10020407 -- Hot flashes | Vascular disorders | meddra9.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cy Stein | City of Hope | 626-359-8111 |
| Aug 17, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C053541 | bicalutamide |
| D017273 | Goserelin |
| D050397 | Radiotherapy, Intensity-Modulated |
| D016729 | Leuprolide |
| C493311 | luprolide acetate gel depot |
| ID | Term |
|---|---|
| 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 |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
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