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| ID | Type | Description | Link |
|---|---|---|---|
| HSC-MS-14-0949 | Other Identifier | UTHSC-H Committee for Protection of Human Subjects |
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Slow accrual; resource re-allocation
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This study is for men who have prostate cancer and have failed local therapy or are not a candidate for prostatectomy or radiation therapy. The purpose of this research study is to assess the safety and benefit of androgen deprivation therapy (ADT, blocks hormones) plus chemotherapy. Degarelix is the hormone blocking drug that will be used. Doxorubicin, Ketoconazole, Docetaxel and Estramustine are the chemotherapy drugs that will be used. The drugs used in this study are approved by the Food and Drug Administration (FDA).
Participants will be treated with ADT plus chemotherapy for three, four, or five 8-week cycles (12, 18, or 24 months). The number of cycles of chemotherapy they receive and the number of months they receive ADT will be based on their disease. The current standard treatment is ADT and chemotherapy. What differs in this research study is the cycling and combination of chemotherapy drugs chosen. The drugs chosen for this study have fewer side effects and are believed to provide maximum benefit.
As a working hypothesis, investigators suspect that the transformation from an androgen-dependent to an androgen-independent phenotype is mediated by expansion of an androgen-independent clone already present at the time of ADT that continues to grow while androgen-sensitive clones are being suppressed. It is thus desirable to bring treatment to bear on the androgen-independent component while the corresponding tumor burden remains minimal and prolong the time to hormone resistance. Investigators view the androgen-independent component as analogous to "microscopic residual" or "micro-metastatic" disease, for which adjuvant chemotherapy has been shown to be effective in other contexts, even when the same drugs had little or no impact on survival in the setting of more advanced disease.
By treating all components of the tumor initially, investigators anticipate that the emergence of androgen-independent growth will be delayed, ultimately prolonging patient survival. Additionally, instead of treating patients empirically with an identical regimen, as in investigator's previous work, these patient subsets were designed to ensure a level of treatment appropriate to their individual disease, thus potentially lessening the burden of treatment (such as the long-term adverse effects of ADT). Investigators have chosen 3, 4, or 5 cycles of chemotherapy to be administered on the basis of tumor burden, a treatment selection method long established in germ cell tumors and used by this PI. Sub-analyses of previous data have raised the concern that treating patients with varying levels of disease the same way does not produce optimal results. Therefore, investigators seek to improve outcomes by tailoring treatment to tumor burden. In this study, patients with less tumor burden will receive 3 cycles of chemotherapy and 12 months of ADT, those with moderate tumor burden will receive 4 cycles and 18 months of treatment, and those with the greatest tumor burden will receive 5 cycles and 24 months of treatment. Additionally, this regimen of administering treatment sequentially, including a 2-week break, reduces toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Definitive local therapy | Active Comparator | 3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix) |
|
| Nodal only/Low-volume bone | Active Comparator | 4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix) |
|
| High volume/no prior tx | Active Comparator | 5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxorubicin | Drug | In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as Measured by Number Who Progressed | Progression defined as increase in Prostate Specific Antigen (PSA) >0.3 ng/mL over 2 measurements or larger/new lesion | From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as Measured by Number of Participants With Pathology/Biopsy Positive for Disease | about 10 months after treatment initiation | |
| Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Amato, DO | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTHealth Memorial Hermann Cancer Center | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Definitive Local Therapy | 3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days |
| FG001 | Nodal Only/Low-volume Bone | 4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days |
| FG002 | High Volume/no Prior tx | 5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Definitive Local Therapy | 3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Efficacy as Measured by Number Who Progressed | Progression defined as increase in Prostate Specific Antigen (PSA) >0.3 ng/mL over 2 measurements or larger/new lesion | Posted | Count of Participants | Participants | From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months |
|
From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months.
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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 | Definitive Local Therapy | 3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
Early termination of study leading to small number of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marka Lyons, Research Manager | The University of Texas Health Science Center at Houston | 713-500-6919 | Marka.Lyons@uth.tmc.edu |
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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 | Jan 26, 2016 | Sep 10, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D007654 | Ketoconazole |
| D000077143 | Docetaxel |
| D004961 | Estramustine |
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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|
| Ketoconazole | Drug | In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) |
|
|
| Docetaxel | Drug | In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) |
|
|
| Estramustine | Drug | In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) |
|
|
| Degarelix | Drug | The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days |
|
|
| baseline |
| Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Cycle 1 Day 1, which is the day of treatment initiation |
| Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Cycle 2 Day 1, which is about 8 weeks after treatment initiation |
| Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Cycle 3 Day 1, which is about 16 weeks after treatment initiation |
| Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Cycle 4 Day 1, which is about 24 weeks after treatment initiation |
| Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Cycle 5 Day 1, which is about about 32 weeks after treatment initiation |
| Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. The time point is the end of treatment, which is about about 8 weeks after the start of the last cycle. For the arm completing 3 cycles, the time point is 24 weeks after treatment initiation. For the arm completing 4 cycles, the time point is 32 weeks after treatment initiation. For the arm completing 5 cycles, the time point is 40 weeks after treatment initiation. | end of treatment, which is about about 8 weeks after the start of the last cycle |
| Efficacy as Measured by Number Who PSA Progressed | PSA progression defined as increase in Prostate Specific Antigen (PSA) >0.3 ng/mL over 2 measurements | From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months |
| Quality of Life Measure by FACT-P Scale | The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL. | post cycle 1, which is about 8 weeks after treatment initiation |
| Quality of Life Measure by FACT-P Scale | The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL. | post cycle 2, which is about 16 weeks after treatment initiation |
| Quality of Life Measure by FACT-P Scale | The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL. | post cycle 3, which is about 24 weeks after treatment initiation |
| Quality of Life Measure by FACT-P Scale | The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL. | post cycle 4, which is about 32 weeks after treatment initiation |
| Quality of Life Measure by FACT-P Scale | The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL. | post cycle 5, which is about about 40 weeks after treatment initiation |
| Quality of Life Measure by FACT-P Scale | The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL. The time point is about 12 weeks after completion of the last cycle. For the arm completing 3 cycles, the time point is 36 weeks after treatment initiation. For the arm completing 4 cycles, the time point is 44 weeks after treatment initiation. For the arm completing 5 cycles, the time point is 52 weeks after treatment initiation. | about 12 weeks after completion of the last cycle |
| Safety of Drug Regimen as Measured by Number of Adverse Events | From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months |
| BG001 | Nodal Only/Low-volume Bone | 4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days |
| BG002 | High Volume/no Prior tx | 5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ECOG Performance Status | The Eastern Cooperative Oncology Group (ECOG) Performance Status scale measures level of functioning. The scale ranges from 0 to 5, with 0 indicating the highest level of functioning and 5 the lowest. | Count of Participants | Participants |
|
| OG001 | Nodal Only/Low-volume Bone | 4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days |
| OG002 | High Volume/no Prior tx | 5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days |
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| Secondary | Efficacy as Measured by Number of Participants With Pathology/Biopsy Positive for Disease | Fewer were analyzed than the number that started or completed the study because not all participants were biopsied following treatment. | Posted | Count of Participants | Participants | about 10 months after treatment initiation |
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|
| Secondary | Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Posted | Median | Full Range | ng/mL | baseline |
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| Secondary | Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Posted | Median | Full Range | ng/mL | Cycle 1 Day 1, which is the day of treatment initiation |
|
|
|
| Secondary | Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Fewer were analyzed than the number that started study because not all participants completed the full number of cycles of treatment assigned. For some participants treatment was prematurely discontinued at different points through the course of treatment because of adverse events, progression, and participant withdrawal from study. | Posted | Median | Full Range | ng/mL | Cycle 2 Day 1, which is about 8 weeks after treatment initiation |
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|
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| Secondary | Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Fewer were analyzed than the number that started study because not all participants completed the full number of cycles of treatment assigned. For some participants treatment was prematurely discontinued at different points through the course of treatment because of adverse events, progression, and participant withdrawal from study. | Posted | Median | Full Range | ng/mL | Cycle 3 Day 1, which is about 16 weeks after treatment initiation |
|
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| Secondary | Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | This time point is after 4 cycles of chemotherapy so no one in group "definitive local therapy" were analyzed. For the other groups fewer were analyzed than the number that started study because for some participants treatment was prematurely stopped at different points in treatment because of adverse events, progression, and withdrawal from study. | Posted | Median | Full Range | ng/mL | Cycle 4 Day 1, which is about 24 weeks after treatment initiation |
|
|
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| Secondary | Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | This time point is after 5 cycles of chemo so so no participants in the groups that had only 3/4 cycles were included. For the other group fewer were analyzed than the number that started study because for some treatment was prematurely stopped at different points in treatment because of adverse events, progression, and withdrawal from study. | Posted | Median | Full Range | ng/mL | Cycle 5 Day 1, which is about about 32 weeks after treatment initiation |
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| Secondary | Efficacy as Measured by PSA Level | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. The time point is the end of treatment, which is about about 8 weeks after the start of the last cycle. For the arm completing 3 cycles, the time point is 24 weeks after treatment initiation. For the arm completing 4 cycles, the time point is 32 weeks after treatment initiation. For the arm completing 5 cycles, the time point is 40 weeks after treatment initiation. | Fewer were analyzed than the number that started study because some participants were taken off study at different points in treatment or follow-up because of adverse events, progression, and withdrawal from study. | Posted | Median | Full Range | ng/mL | end of treatment, which is about about 8 weeks after the start of the last cycle |
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| Secondary | Efficacy as Measured by Number Who PSA Progressed | PSA progression defined as increase in Prostate Specific Antigen (PSA) >0.3 ng/mL over 2 measurements | Posted | Count of Participants | Participants | From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months |
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|
|
| Secondary | Quality of Life Measure by FACT-P Scale | The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL. | Posted | Median | Full Range | units on a scale | post cycle 1, which is about 8 weeks after treatment initiation |
|
|
|
| Secondary | Quality of Life Measure by FACT-P Scale | The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL. | Fewer were analyzed than the number that started study because not all participants completed the full number of cycles of treatment assigned. For some participants treatment was prematurely discontinued at different points through the course of treatment because of adverse events, progression, and participant withdrawal from study. | Posted | Median | Full Range | units on a scale | post cycle 2, which is about 16 weeks after treatment initiation |
|
|
|
| Secondary | Quality of Life Measure by FACT-P Scale | The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL. | Fewer were analyzed than the number that started study because some participants were taken off study at different points throughout the study because of adverse events, progression, and participant withdrawal from study. Additionally, some participants did not wish to complete the FACT-P questionnaire. | Posted | Median | Full Range | units on a scale | post cycle 3, which is about 24 weeks after treatment initiation |
|
|
|
| Secondary | Quality of Life Measure by FACT-P Scale | The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL. | This is after 4 cycles of chemo so no one in group "definitive local therapy" were analyzed. For the other groups fewer were analyzed than the number that started study because for some participants treatment or follow-up was prematurely stopped at different points because of adverse events, progression, and withdrawal from study. | Posted | Median | Full Range | units on a scale | post cycle 4, which is about 32 weeks after treatment initiation |
|
|
|
| Secondary | Quality of Life Measure by FACT-P Scale | The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL. | This time point is after 5 cycles of chemo so so no participants in the groups that had only 3/4 cycles were included. For the other group fewer were analyzed than the number that started study because for some treatment was prematurely stopped at different points in treatment because of adverse events, progression, and withdrawal from study. | Posted | Median | Full Range | units on a scale | post cycle 5, which is about about 40 weeks after treatment initiation |
|
|
|
| Secondary | Quality of Life Measure by FACT-P Scale | The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL. The time point is about 12 weeks after completion of the last cycle. For the arm completing 3 cycles, the time point is 36 weeks after treatment initiation. For the arm completing 4 cycles, the time point is 44 weeks after treatment initiation. For the arm completing 5 cycles, the time point is 52 weeks after treatment initiation. | Fewer were analyzed than the number that started study because some participants were taken off study at different points in treatment or follow-up because of adverse events, progression, and withdrawal from study. | Posted | Median | Full Range | units on a scale | about 12 weeks after completion of the last cycle |
|
|
|
| Secondary | Safety of Drug Regimen as Measured by Number of Adverse Events | Posted | Number | adverse event | From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months |
|
|
|
| 0 |
| 6 |
| 3 |
| 6 |
| 6 |
| 6 |
| EG001 | Nodal Only/Low-volume Bone | 4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days | 0 | 8 | 2 | 8 | 8 | 8 |
| EG002 | High Volume/no Prior tx | 5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix) Doxorubicin: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days | 0 | 5 | 0 | 5 | 5 | 5 |
| Sinus Tachycardia | Cardiac disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Fever | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Chills | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Fatigue | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Creatinine Increased | Investigations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| White blood cell decreased | Investigations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Post nasal drip | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders, Pulmonary inflammation | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Cardiac disorders, Inverted T-wave on EKG | Cardiac disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Blurred Vision | Eye disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Dry Eye | Eye disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Eye disorders, Red eyes | Eye disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Watering eyes | Eye disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Gastroesophageal Reflux | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Gastrointestinal Disorders, Loose stools | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Mucositis Oral | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Stomach Pain | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Chills | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Edema face | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Edema limbs | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Edema trunk | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Fatigue | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Fever | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Flu like symptoms | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| General disorders and administration site conditions, Foot irritation/infection | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Infusion related reaction | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Injection Site Reaction | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Irritability | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Malaise | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Pain | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Infections and Infestations, Thrush | Infections and infestations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Alkaline Phosphatase Increased | Investigations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Creatinine increased | Investigations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Weight gain | Investigations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Weight loss | Investigations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| White blood cell decreased | Investigations | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Metabolism and nutrition disorders, Hyperlipidemia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Concentration impairment | Nervous system disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Dysguesia | Nervous system disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Nervous system Disorders, Disease | Nervous system disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Psychiatric disorder, Emotional | Psychiatric disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Renal and urinary disorders, Dysuria | Renal and urinary disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Urine discoloration | Renal and urinary disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Penile pain | Reproductive system and breast disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Prostatic pain | Reproductive system and breast disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Reproductive system and breast disorders, Penile irritation | Reproductive system and breast disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders, Nasal discharge | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders, Skin irritation | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Nail discoloration | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Nail loss | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Surgical and medical procedures, Soreness at site | Surgical and medical procedures | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hot flashes | Vascular disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Cardiac disorders, Atherosclerotic Ulcer in Posterior Arch of Aorta | Cardiac disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Eye disorders, Decreased vision | Eye disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Eye disorders, Discharge from eye | Eye disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Gastrointestinal disorders, tongue changes | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Gastrointestinal disorders, Abdominal cramping | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Gastrointestinal disorders, Motion sickness | Gastrointestinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| General disorders, Body aches/pain | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| General disorders, Facial/Lip irritation | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| General disorders, Mental Fogginess/Forgetfulness | General disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Renal and urinary disorders, Nocturia | Renal and urinary disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Renal and urinary disorders, Urinary burning | Renal and urinary disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders, Dry nostrils | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders, Nail changes | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders, Sweating | Skin and subcutaneous tissue disorders | NCI CTCAE Versio 4.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |