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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02278185
Other study ID # 14-0909.cc
Secondary ID NCI-2014-02219
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 11, 2015
Est. completion date April 10, 2025

Study information

Verified date May 2024
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

Drug:
Enzalutamide
Given PO
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

Locations

Country Name City State
United States University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora Colorado
United States University of Colorado Health - Poudre Valley Hospital Fort Collins Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. Within the first 12 months of therapy
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. Within the first 6 months of therapy
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. Baseline and month 12
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:
T-score of -1.0 or above = normal bone density
T-score between -1.0 and -2.5 = low bone density, or osteopenia
T-score of -2.5 or lower = osteoporosis
Baseline to 12 months
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.
Baseline to up to 12 months
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. Baseline to up to 12 months
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).
Baseline to up to 7 months
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. 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
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. 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
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 Difference between baseline and 12 months.
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 Up to 30 days after the last dose of study drug
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. Difference between baseline and 12 months.
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). Baseline and 12 months
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