The purpose of this study is to describe the 2 year progression-free survival in men with recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard androgen-deprivation therapy (ADT) with salvage radiation therapy. Eligible men will have recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of 0.2 - 4 in the absence of metastatic disease on CT and bone scans. In addition to standard ADT and radiation therapy, research participants will take enzalutamide once daily for six months. It is primarily hypothesized the 2 year PFS rate will be improved with the combined therapy compared to the historical control data in a similar patients setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
160 mg orally once daily for six months
Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Two Year Progression-free Survival
Percentage of patients surviving 2 years from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks OR evidence of clinical progression or initiation of systemic therapy for progressive disease
Time frame: 2 years
PSA Less Than 0.1
The percentage of men with PSA less than 0.1 ng/mL and testosterone greater than 100
Time frame: every year, up to 3 years
Three Year Progression-free Survival
Percentage of patients surviving 3 years from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks OR evidence of clinical progression or initiation of systemic therapy for progressive disease
Time frame: 3 years
Biochemical Progression-free Survival
Percentage of patients surviving 2 and 3 years from the start of study treatment without progression of disease. Biochemical PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks
Time frame: 3 years
PSA Nadir
Median PSA nadir post-radiation therapy
Time frame: 8 weeks
Time to Testosterone Recovery
Percentage of patients with recovering testosterone to \> 100 at 1, 2, and 3 years.
Time frame: 3 years
Number of Patients With Adverse Events Related to Combination Enzalutamide, ADT, and XRT
Safety and tolerability will be assessed using CTCAE v4.0
Time frame: 3 years
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