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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02219 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This randomized phase II trial compares enzalutamide with standard androgen deprivation therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has spread to other places in the body. Metabolic syndrome is defined as changes in cholesterol, blood pressure, circulating sugar levels, and body weight. Previous studies have shown that patients with prostate cancer, who have been treated with standard medical therapy that lowers testosterone levels, have an increased risk of these changes. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells instead of lowering testosterone levels. It is not yet known whether prostate cancer patients who receive enzalutamide will have reduced incidence of metabolic syndrome than patients who receive standard androgen deprivation therapy.
PRIMARY OBJECTIVES:
I. To determine the incidence of metabolic syndrome within 12 months, as defined by the Adult Treatment Panel III, in patients treated with enzalutamide compared to standard androgen deprivation therapy.
SECONDARY OBJECTIVES:
I. To determine the incidence of metabolic syndrome within 6 months, as defined by the Adult Treatment Panel III, in patients treated with enzalutamide compared to standard androgen deprivation therapy.
II. To assess bone health, as measured by a dual-energy x-ray absorptiometry (DXA) scanner.
III. To assess body composition (sarcopenic obesity), as measured by a DXA scanner.
IV. To assess quality of life (QOL), as measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Sexual Health Inventory in Men (SHIM).
V. To assess time to prostate-specific antigen (PSA) progression and time to radiographic progression.
VI. To assess the incidence of developing individual risk factors, or components, which comprise metabolic syndrome.
VII. To assess the change in high-sensitivity C-reactive protein (hs-CRP) as a marker of inflammation.
VIII. To assess the safety and tolerance of enzalutamide or androgen deprivation therapy (ADT).
IX. To assess the change in physical function as measured by the Short Physical Performance Battery (SPPB).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive enzalutamide orally (PO) once daily (QD) for 12 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix subcutaneously (SC) or intramuscularly (IM) for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT.
After completion of study treatment, patients are followed up at 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (enzalutamide) | Experimental | Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. |
|
| Arm II (ADT) | Active Comparator | Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Syndrome Incidence, Summarized by the Number of Patients With at Least 3 of the 5 Pre-specified Criteria | Metabolic syndrome will be assessed at the beginning of each course and defined by the presence of 3 of the following five traits: abdominal obesity, defined as a waist circumference > 102 cm (> 40 in); serum triglycerides >= 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides; serum high density lipoprotein (HDL) cholesterol < 40 mg/dL (1 mmol/L) or drug treatment for low HDL; blood pressure >= 130/>= 85 mmHg or drug treatment for elevated blood pressure; and fasting plasma glucose (FPG) >= 100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose. | Within the first 12 months of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Syndrome Incidence, Summarized by the Proportion of Patients With at Least 3 of the 5 Pre-specified Criteria | Metabolic syndrome will be assessed at the beginning of each course and defined by the presence of 3 of the following five traits: abdominal obesity, defined as a waist circumference > 102 cm (> 40 in); serum triglycerides >= 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides; serum HDL cholesterol < 40 mg/dL (1 mmol/L) or drug treatment for low HDL; blood pressure >= 130/>= 85 mmHg or drug treatment for elevated blood pressure; and FPG >= 100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Kessler, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Enzalutamide) | Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO |
| FG001 | Arm II (ADT) |
| 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 | Apr 27, 2018 |
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| leuprolide acetate | Drug | Given SC or IM |
|
|
| goserelin acetate | Drug | Given SC or IM |
|
|
| histrelin acetate | Drug | Given SC or IM |
|
|
| triptorelin | Drug | Given SC or IM |
|
|
| degarelix | Drug | Given SC or IM |
|
|
| Within the first 6 months of therapy |
| Change in Bone Turnover Markers, as Measured by Bone-specific Alkaline Phosphatase | Will be assessed for each treatment group. Measurements will be taken at day 1 of each course. A paired t-test will test within an arm as to whether the change from baseline to 12 months is significantly different from zero. | Baseline and month 12 |
| Change in Bone Density | We will measure bone density via a DXA scanner, Left Femur and Right femur T scores will be added to a composite score. A paired t-test will test within an arm as to whether the change from baseline to twelve months is significantly different from zero. The T-score is the standard deviation of how much bone density differs from the bone mass of an average healthy 30 year old. A score of 0 indicates no deviation from average. The following ranges are used:
| Baseline to 12 months |
| Change in Free Fat Mass, as Measured by a DXA Scanner | A paired t-test will test within an arm as to whether the change from baseline to each time point is significantly different from zero. These data are not able to be reported as the DXA did not measure free fat mass and thus we will be using cross sectional CT analysis. | Baseline to up to 12 months |
| Change in Fat Mass, as Measured by a DXA Scanner | A paired t-test will test within an arm as to whether the change from baseline to each time point is significantly different from zero. | Baseline to up to 12 months |
| Change in Quality of Life (QOL) Scores, as Measured by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) and Sexual Health in Men (SHIM) | The FACT-P is the Functional Assessment of Cancer Therapy - Prostate and measures physical/emotional quality of life in prostate cancer patients. NUMBER OF ITEMS:39 PATIENT POPULATION:Prostate cancer patients 18 years and older RECALL PERIOD:Past 7 days RESPONSE SCALE:5 point Likert-type scale SUBSCALE DOMAINS: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), Prostate Cancer Subscale (PCS) SCORING: Scores range from 0-158. In general, the higher the score, the better the quality of life. Sexual Health in Men (SHIM). 5 item measure of erectile function. Total score is 1-25 with a higher score indicating better sexual health. Scores: no ED (SHIM total score, 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe ED (1-7). | Baseline to up to 7 months |
| Number of Patients With PSA Progression | PSA progression as defined by an increase in >= 50% from nadir and an absolute increase of at least 2 ng/mL above the nadir, occurring at least 12 weeks after start of therapy that is confirmed by two consecutive increases taken at least 2 weeks apart. Log rank test will be used to compare the distributions of above variables between the group treated with enzalutamide to the group on standard ADT. | Time from randomization to the earliest objective evidence of PSA progression as defined per protocol, assessed up to 30 days after the last dose of study drug |
| Time to Radiographic Progression | Log rank test will be used to compare the distributions of above variables between the group treated with enzalutamide to the group on standard ADT. | Time from randomization to the earliest objective evidence of radiographic progression as defined per protocol, assessed up to 30 days after the last dose of study drug |
| Change in Markers of Inflammation, as Measured by Circulating Hs-CRP | Mean change in available samples from baseline to 12 months, presented in mg/dL | Difference between baseline and 12 months. |
| Incidence of Adverse Events, Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.1 | The incidence of adverse events has been reported in the adverse events log for clinicaltrials.gov | Up to 30 days after the last dose of study drug |
| Change in Physical Function, as Measured by Short Physical Performance Battery (SPPB). | The Short SPPB incorporates 3 validated portions to assess a patient's balance and mobility. SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness. The higher the score, the better the physical function. Will be measured as a continuous outcome. | Difference between baseline and 12 months. |
| Change in Bone Turnover Markers as Measured by N-telopeptide | Will be assessed for each treatment group. Measurements will be taken at day 1 of each course. A paired t-test within an arm as to whether the change from baseline to 12 months is significantly different from zero. N-Telopeptide units - nM Bone Collagen Equivalent (BCE). | Baseline and 12 months |
| University of Colorado Health - Poudre Valley Hospital |
| Fort Collins |
| Colorado |
| 80524 |
| United States |
Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT.
leuprolide acetate: Given SC or IM
goserelin acetate: Given SC or IM
histrelin acetate: Given SC or IM
triptorelin: Given SC or IM
degarelix: Given SC or IM
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Enzalutamide) | Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO |
| BG001 | Arm II (ADT) | Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| PSA value | Median | Full Range | NG/ML |
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| Metastatic disease | Count of Participants | Participants |
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| 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 | Metabolic Syndrome Incidence, Summarized by the Number of Patients With at Least 3 of the 5 Pre-specified Criteria | Metabolic syndrome will be assessed at the beginning of each course and defined by the presence of 3 of the following five traits: abdominal obesity, defined as a waist circumference > 102 cm (> 40 in); serum triglycerides >= 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides; serum high density lipoprotein (HDL) cholesterol < 40 mg/dL (1 mmol/L) or drug treatment for low HDL; blood pressure >= 130/>= 85 mmHg or drug treatment for elevated blood pressure; and fasting plasma glucose (FPG) >= 100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose. | Posted | Count of Participants | Participants | Within the first 12 months of therapy |
|
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| Secondary | Metabolic Syndrome Incidence, Summarized by the Proportion of Patients With at Least 3 of the 5 Pre-specified Criteria | Metabolic syndrome will be assessed at the beginning of each course and defined by the presence of 3 of the following five traits: abdominal obesity, defined as a waist circumference > 102 cm (> 40 in); serum triglycerides >= 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides; serum HDL cholesterol < 40 mg/dL (1 mmol/L) or drug treatment for low HDL; blood pressure >= 130/>= 85 mmHg or drug treatment for elevated blood pressure; and FPG >= 100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose. | Includes all patients still participating at this timepoint | Posted | Count of Participants | Participants | Within the first 6 months of therapy |
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| Secondary | Change in Bone Turnover Markers, as Measured by Bone-specific Alkaline Phosphatase | Will be assessed for each treatment group. Measurements will be taken at day 1 of each course. A paired t-test will test within an arm as to whether the change from baseline to 12 months is significantly different from zero. | Patients were compared to themselves as well as across groups. We reviewed difference from month 1 to 12 in order to gather adequate data. Below are the bone-specific alkaline phosphatase. Not all patients completed follow up for this measure. | Posted | Mean | Standard Deviation | microgram/L | Baseline and month 12 |
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| Secondary | Change in Bone Density | We will measure bone density via a DXA scanner, Left Femur and Right femur T scores will be added to a composite score. A paired t-test will test within an arm as to whether the change from baseline to twelve months is significantly different from zero. The T-score is the standard deviation of how much bone density differs from the bone mass of an average healthy 30 year old. A score of 0 indicates no deviation from average. The following ranges are used:
| Not all patients completed follow-up for this measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
|
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| Secondary | Change in Free Fat Mass, as Measured by a DXA Scanner | A paired t-test will test within an arm as to whether the change from baseline to each time point is significantly different from zero. These data are not able to be reported as the DXA did not measure free fat mass and thus we will be using cross sectional CT analysis. | The DXA scanner was not able to analyze free fat mass, only bone density. | Posted | Baseline to up to 12 months |
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| Secondary | Change in Fat Mass, as Measured by a DXA Scanner | A paired t-test will test within an arm as to whether the change from baseline to each time point is significantly different from zero. | data cannot be reported as the dexa scanner used for the study only measured bone density and not lean body mass (this was realized part way through study). | Posted | Baseline to up to 12 months |
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| Secondary | Change in Quality of Life (QOL) Scores, as Measured by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) and Sexual Health in Men (SHIM) | The FACT-P is the Functional Assessment of Cancer Therapy - Prostate and measures physical/emotional quality of life in prostate cancer patients. NUMBER OF ITEMS:39 PATIENT POPULATION:Prostate cancer patients 18 years and older RECALL PERIOD:Past 7 days RESPONSE SCALE:5 point Likert-type scale SUBSCALE DOMAINS: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), Prostate Cancer Subscale (PCS) SCORING: Scores range from 0-158. In general, the higher the score, the better the quality of life. Sexual Health in Men (SHIM). 5 item measure of erectile function. Total score is 1-25 with a higher score indicating better sexual health. Scores: no ED (SHIM total score, 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe ED (1-7). | Patients were compared to themselves as well as across groups. We reviewed difference from month 1 to 7 in order to gather adequate data. Below is the SHIM. | Posted | Mean | Standard Deviation | score on a scale | Baseline to up to 7 months |
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| Secondary | Number of Patients With PSA Progression | PSA progression as defined by an increase in >= 50% from nadir and an absolute increase of at least 2 ng/mL above the nadir, occurring at least 12 weeks after start of therapy that is confirmed by two consecutive increases taken at least 2 weeks apart. Log rank test will be used to compare the distributions of above variables between the group treated with enzalutamide to the group on standard ADT. | All patients were evaluated throughout the course of the study | Posted | Count of Participants | Participants | Time from randomization to the earliest objective evidence of PSA progression as defined per protocol, assessed up to 30 days after the last dose of study drug |
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| Secondary | Time to Radiographic Progression | Log rank test will be used to compare the distributions of above variables between the group treated with enzalutamide to the group on standard ADT. | All participants included in analysis. | Posted | Mean | Standard Deviation | Months | Time from randomization to the earliest objective evidence of radiographic progression as defined per protocol, assessed up to 30 days after the last dose of study drug |
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| Secondary | Change in Markers of Inflammation, as Measured by Circulating Hs-CRP | Mean change in available samples from baseline to 12 months, presented in mg/dL | Patients were compared to themselves as well as across groups. We reviewed difference from month 1 to 12 in order to gather adequate data. Some patients in the cohort were missing follow-up data. | Posted | Mean | Standard Deviation | mg/dL | Difference between baseline and 12 months. |
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| Secondary | Incidence of Adverse Events, Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.1 | The incidence of adverse events has been reported in the adverse events log for clinicaltrials.gov | adverse events reported in separate section | Posted | Count of Participants | Participants | Up to 30 days after the last dose of study drug |
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| Secondary | Change in Physical Function, as Measured by Short Physical Performance Battery (SPPB). | The Short SPPB incorporates 3 validated portions to assess a patient's balance and mobility. SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness. The higher the score, the better the physical function. Will be measured as a continuous outcome. | Not all patients completed follow-up for this measure. | Posted | Mean | Standard Deviation | score on a scale | Difference between baseline and 12 months. |
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| Secondary | Change in Bone Turnover Markers as Measured by N-telopeptide | Will be assessed for each treatment group. Measurements will be taken at day 1 of each course. A paired t-test within an arm as to whether the change from baseline to 12 months is significantly different from zero. N-Telopeptide units - nM Bone Collagen Equivalent (BCE). | Patients were compared to themselves as well as across groups. We reviewed difference from month 1 to 12 to gather adequate data. Below are the N-telopeptide. Not all patients completed follow-up for this measure. | Posted | Mean | Standard Deviation | nM BCE | Baseline and 12 months |
|
Monitoring of adverse events was conducted throughout the study. These were reported from the date written informed consent and through 30 days post-last dose of study drug.
There is no difference in our definition of an adverse event and that of clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Enzalutamide) | Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Enzalutamide: Given PO | 0 | 10 | 1 | 10 | 10 | 10 |
| EG001 | Arm II (ADT) | Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT. leuprolide acetate: Given SC or IM goserelin acetate: Given SC or IM histrelin acetate: Given SC or IM triptorelin: Given SC or IM degarelix: Given SC or IM | 1 | 9 | 3 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subarachnoid Hemmorhage | Nervous system disorders | Non-systematic Assessment |
| ||
| Radiation esophagitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hypertriglyceridemia | Metabolism and nutrition disorders | Systematic Assessment | Grade 4 elevation in triglycerides possibly related to study treatment and resolved in folow up. |
| |
| Spinal cord compression | Nervous system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| neutrophil count decreased | Blood and lymphatic system disorders | Systematic Assessment |
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| activity change | Metabolism and nutrition disorders | Systematic Assessment |
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| alcohol abuse | Social circumstances | Systematic Assessment |
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| Allergic rhinitis | Immune system disorders | Systematic Assessment |
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| ALT increase | Hepatobiliary disorders | Systematic Assessment |
| ||
| anal bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| anxiety | Psychiatric disorders | Systematic Assessment |
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| arthralgias | Immune system disorders | Systematic Assessment |
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| ast increase | Hepatobiliary disorders | Systematic Assessment |
| ||
| ataxia | Nervous system disorders | Systematic Assessment |
| ||
| back pain | General disorders | Systematic Assessment |
| ||
| Basal cell skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| jaw pain | General disorders | Systematic Assessment |
| ||
| hyperbilirubinemia | Hepatobiliary disorders | Systematic Assessment |
| ||
| Bloating | Gastrointestinal disorders | Systematic Assessment |
| ||
| chest pain | Cardiac disorders | Systematic Assessment |
| ||
| cognitive changes | Nervous system disorders | Systematic Assessment |
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| Constipation | Metabolism and nutrition disorders | Systematic Assessment |
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| Dark urine | Renal and urinary disorders | Systematic Assessment |
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| Decreased concentration | Nervous system disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Ear other | Ear and labyrinth disorders | Systematic Assessment |
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| Elevated triglyceride | Cardiac disorders | Systematic Assessment |
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| erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
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| Eye disorders (other) | Eye disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| flatulence | Gastrointestinal disorders | Systematic Assessment |
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| fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| GERD | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gynecomastia | Reproductive system and breast disorders | Systematic Assessment |
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| Alopecia | Immune system disorders | Systematic Assessment |
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| hematuria | Renal and urinary disorders | Systematic Assessment |
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| Hep A | Hepatobiliary disorders | Systematic Assessment |
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| Hot Flashes | General disorders | Systematic Assessment |
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| hypertension | Cardiac disorders | Systematic Assessment |
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| Hypertriglyceridemia | Endocrine disorders | Systematic Assessment |
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| vision change | Eye disorders | Systematic Assessment |
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| insomnia | General disorders | Systematic Assessment |
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| cough | General disorders | Systematic Assessment |
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| nasal congestion | Immune system disorders | Systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Loose stool | Gastrointestinal disorders | Systematic Assessment |
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| memory change | Psychiatric disorders | Systematic Assessment |
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| myalgias | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Rhinorrhea | Immune system disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Neck pain | General disorders | Systematic Assessment |
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| creatnine increased | Renal and urinary disorders | Systematic Assessment |
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| decreased libido | Reproductive system and breast disorders | Systematic Assessment |
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| neuropathy | Nervous system disorders | Systematic Assessment |
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| Osteopenia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Movements involuntary | Nervous system disorders | Systematic Assessment |
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| middle ear inflammation | Ear and labyrinth disorders | Systematic Assessment |
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| skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| hydrocephalus | Nervous system disorders | Systematic Assessment |
| ||
| radiculitis | Nervous system disorders | Systematic Assessment |
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| dehydration | General disorders | Systematic Assessment |
| ||
| sinus congestion | Immune system disorders | Systematic Assessment |
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| Sleep disturbance | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| dental problems | General disorders | Systematic Assessment |
| ||
| tinnitus | Ear and labyrinth disorders | Systematic Assessment |
| ||
| dysguesia | Gastrointestinal disorders | Systematic Assessment |
| ||
| tremors | Nervous system disorders | Systematic Assessment |
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| Weight gain | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary urgency | Renal and urinary disorders | Systematic Assessment |
| ||
| emotional lability | Psychiatric disorders | Systematic Assessment |
| ||
| Voice alteration | General disorders | Systematic Assessment |
| ||
| weakness | General disorders | Systematic Assessment |
| ||
| Weight loss | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| epistaxis | Ear and labyrinth disorders | Systematic Assessment |
| ||
| esophagitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| facial swelling | General disorders | Systematic Assessment |
| ||
| fall | General disorders | Systematic Assessment |
| ||
| hyperglycemia | Endocrine disorders | Systematic Assessment |
| ||
| nystagmus | Ear and labyrinth disorders | Systematic Assessment |
| ||
| influenza | General disorders | Systematic Assessment |
| ||
| seizure | Nervous system disorders | Systematic Assessment |
| ||
| edema | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| lymphocyte decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| night sweats | Nervous system disorders | Systematic Assessment |
| ||
| injection site reaction | Surgical and medical procedures | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sneezing | Immune system disorders | Systematic Assessment |
| ||
| spinal cord compression | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| subarachnoid hemmorhage | Nervous system disorders | Systematic Assessment |
| ||
| trouble swallowing | Nervous system disorders | Systematic Assessment |
| ||
| urinary frequency | Renal and urinary disorders | Systematic Assessment |
| ||
| vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
This study was originally designed when ADT alone was SOC treatment for metastatic prostate cancer. In the years of opening and enrollment, the SOC changed thus affecting the population of potentially eligible patients.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth R Kessler | University of Colorado School of Medicine | 720-848-0402 | elizabeth.kessler@cuanschutz.edu |
| Jul 14, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540278 | enzalutamide |
| D016729 | Leuprolide |
| D017273 | Goserelin |
| C029256 | histrelin |
| D017329 | Triptorelin Pamoate |
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| 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 |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
Cohort characteristics for Metabolic Syndrome were summarized by event and arm using counts and percentages for categorical variables and the mean, standard deviation, median, and quartiles for continuous variables. The difference between metabolic syndrome and treatment were evaluated with the Chi-square test. P-values are reported based on a null hypothesis of no difference against a two-sided alternative. Analyses were performed using SAS 9.4 (SAS Inst |
| Chi-squared |
| 0.46 |
| Superiority |
Cohort characteristics for Metabolic Syndrome, the SPPB, the SHIM/FACT-P, and PSA were summarized by event and arm using counts and percentages for categorical variables and the mean, standard deviation, median, and quartiles for continuous variables. The difference between metabolic syndrome and treatment were evaluated with the Chi-square test. The Wilcoxon signed-rank test was utilized to examine the difference between Month 1 and Month 12 SPPB scores. The Wilcoxon rank-sum test was used to assess the difference of SHIM/FACT-P scores and PSA between arms. These tests were chosen to account for the non-normal distributions of the continuous variables. The difference between PSA progression between arms was examined using the Fisher Exact Test. A heat map of scores ordered by the highest average score was also created. P-values are reported based on a null hypothesis of no difference against a two-sided alternative. Analyses were performed using SAS 9.4 (SAS Inst |
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