This randomized phase II trial studies if enzalutamide added to standard luteinizing hormone-releasing hormone (LHRH) analogue therapy will improve effects against prostate cancer compared to the standard therapy of LHRH analogue and bicalutamide. Hormone therapies stop the body from producing or block the effect of male sex hormones (testosterone). Enzalutamide blocks the effect of male sex hormones which are responsible for the growth of prostate cancer. Hormonal therapies that lower the level of testosterone are among the most effective treatments for prostate cancer that have spread to other areas of the body (metastasized). It is not yet known whether LHRH analogue therapy with bicalutamide is more effective than LHRH analogue therapy with enzalutamide in treating prostate cancer.
PRIMARY OBJECTIVES: I. To compare the rates of achieving prostate-specific antigen (PSA) remission at month 7 with LHRH analogue therapy and enzalutamide (Arm A) with that achieved with LHRH analogue and bicalutamide (Arm B) in metastatic hormone sensitive prostate cancer. SECONDARY OBJECTIVES: I. To compare the primary endpoint by race. II. To compare the rates of each of 2 types of response by treatment arm: measurable disease response; and PSA response. III. To compare each of 7 time-to-event endpoints by treatment arm: duration of overall response (RD); duration of stable disease (SDD); time to treatment failure (TTF); time-to-progression (TTP); TTP in patients with bone metastases; progression-free survival (PFS); and overall survival (OS). IV. To compare the rates of each type of toxicity by treatment arm. V. To compare the incidence rate of skeletal related events (SRE), and the time until SRE, separately by treatment arm. VI. To compare the rates of circulating tumor cell (CTC) response by treatment arm. VIII. To explore the molecular mechanisms within the androgen receptor pathway by determining the levels of chemokine (C-X-C motif) receptor 4 (CXCR4) and transmembrane protease, serine 2 (TMPRSS2)-v-ets avian erythroblastosis virus E26 oncogene homolog (ERG) expression, androgen metabolism enzymes; androgen receptor variants, and length of cytosine-adenine-guanine (CAG) repeats within the androgen receptor gene, and to associate them with the primary endpoint. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive enzalutamide orally (PO) once daily (QD) and undergo orchiectomy or receive LHRH analogue therapy (leuprolide acetate, goserelin acetate, or any other Food and Drug Administration \[FDA\] approved preparation). Treatment continues in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive bicalutamide PO QD and undergo orchiectomy or receive LHRH analogue therapy as in Arm A. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Given PO
Given PO
Undergo orchiectomy or receive LHRH analogue therapy
Undergo orchiectomy or receive LHRH analogue therapy
Undergo orchiectomy or receive LHRH analogue therapy
Correlative studies
University of Alabama at Birmingham
Birmingham, Alabama, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Number of Participants With PSA Remission Assessed Using the Prostate Cancer Clinical Trials Working Group (PCWG2) Criteria
Number of Participants with PSA Remission Assessed Using the Prostate Cancer Clinical Trials Working Group (PCWG2) Criteria specifically at the 7 month time point. The binary endpoint (yes/no) will be summarized with its point estimate (an occurrence rate), and 2-sided Wilson type 95% confidence interval (CI). PSA response rates will be compared by treatment arm in a stratified logistic regression model.
Time frame: Month 7
Achievement of Measurable Disease Response
The number of participants with Measurable disease response per RECIST v1.1.
Time frame: Up to 2 years
Achievement of PSA Response Assessed Using PCWG2 Criteria
Will be summarized with point estimates (occurrence rates), and 2-sided Wilson type 95% CIs.
Time frame: Up to 2 years
The Percentage of Patients Responding
Point estimates will be calculated and CI estimates will be derived from the Wilcoxon method using STATA software.
Time frame: 6 months
Time to Treatment Failure
Time to Treatment Failure from date of first treatment to date off treatment or date patient is taken off study for any reason. TTF will be estimated with standard K-M methodology. Point and CI estimates of the median and various time point-specific rates will be derived from the K-M life table.
Time frame: Assessed up to 6 years.
Percentage of Patients Progression Free at One Year
Percentage of patients progression free at one year using the Kaplan-Meier method.
Time frame: assessed at 1 year
Percentage of Patients With Bone Metastases Progression Free at Six Months
Percentage of patients with bone metastases Progression free at six months using the Kaplan-Meier method.
Time frame: assessed at six months
Percentage of Patients Progression-free at 6 Months
Will be estimated with standard K-M methodology. Point and CI estimates of the six-month rate will be derived from the K-M life table.
Time frame: From registration to PSA progression defined by PCWG II criteria or measurable disease by RECIST 1.1, assessed at 6 months
Overall Survival at 2 Years
Overall Survival will be measured from date of registration to death or last follow up. OS will be estimated with standard K-M methodology. Point and CI estimates of the 2-year rate will derived from the K-M life table.
Time frame: Assessed at 2 years
The Number of Participants With a CTC Response
Will be summarized with point estimates (occurrence rates). A CTC response is defined as any level of CTC \< 5 that is maintained or any level of CTC that is reduced from baseline.
Time frame: Up to month 1
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