The purpose of this study is to describe the rate of 3-year progression free survival in men with recurrent PSA-only disease after prostatectomy, who receive combined apalutamide (ARN-509) and standard ADT with salvage radiation therapy followed by docetaxel, ADT, and apalutamide, AND who have had testosterone recovery to \>100 ng/dl at 36 months. The hypothesis is that AR inhibition with apalutamide added to standard salvage external beam radiation with androgen deprivation therapy, as well as the addition of 6 cycles of docetaxel, will further prolong progression free survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
240mg tablet daily for 36 weeks
ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
GU Research Network / Urology Cancer Center
Omaha, Nebraska, United States
Weill Cornell Medical Center
New York, New York, United States
Duke Cancer Center Cary
Cary, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest Univesity
Winston-Salem, North Carolina, United States
Progression-free Survival (PFS) at 36 Months (3 Years)
The percentage of subjects with testosterone \>100 ng/dl at 36 months post-Cycle 1 Day 1 without one or more of the following: Serum PSA value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed (at least) 4 weeks later by a second PSA measurement higher than the first by any amount; Continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks; Evidence of clinical progression or initiation of systemic therapy for progressive disease; Death
Time frame: up to 36 months
Number of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 12 Months Post-Cycle 1 Day 1
Testosterone recovery defined as testosterone \>100 ng/dl
Time frame: 12 months
Percentage of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 24 Months Post-Cycle 1 Day 1
Testosterone recovery defined as testosterone \>100 ng/dl
Time frame: 24 months
Percentage of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 36 Months Post-Cycle 1 Day 1
Testosterone recovery defined as testosterone \>100 ng/dl
Time frame: 36 months
Biochemical Progression-free Survival (PFS) at 36 Months (3 Years)
Percentage of participants still alive without disease progression based on PSA (prostate-specific antigen) only. Must have serum PSA value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed (at least) 4 weeks later by a second PSA measurement higher than the first by any amount.
Time frame: 36 months
Median PSA Nadir Value
Median PSA nadir value
Time frame: 36 months
Time to Testosterone Recovery
Testosterone recovery defined as testosterone \>100 ng/dl
Time frame: up to 36 months
Percentage of Participants With Adverse Events as Assessed by CTCAE v4.0
To describe the safety, feasibility and tolerability profile of combination apalutamide, ADT, and radiation therapy followed by apalutamide, ADT, and docetaxel as assessed by NCI common toxicity scales
Time frame: up to 36 months
Percentage of Participants Completing All Treatments
To describe the percentage of participants completing all treatments including salvage radiation therapy and 6 cycles of docetaxel
Time frame: 36 months
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