The addition of abiraterone acetate to standard treatment of radiotherapy and short-term androgen deprivation will increase the frequency of undetectable PSA.
This is a single arm two-site study of 37 men with unfavorable prostate cancer (defined as having a single high risk factor). Patients will concurrently initiate 6 months of standard-of-care GNRH agonist therapy and once daily abiraterone acetate/prednisone. After 2 months of lead-in hormonal treatment, definitive standard-of-care prostate/seminal vesicle radiotherapy will be delivered, to a total dose of 75-80 Gy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
1000 mg orally once a day for 6 months.
LHRH analog (at discretion of treating physician) will be administered over 6 months (for example, leuprolide acetate 22.5mg IM or goserelin acetate 10.8mg SC given every 3 months for 2 doses).
Daily (Monday-Friday) for 8 weeks, final dose of 75-80 Gy
Durham Regional Hospital
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year
The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of \<0.1 ng/mL.
Time frame: 1 year
Time to PSA Nadir
The median time in months to the lowest PSA value from the start of study therapy.
Time frame: 1 year
PSA Nadir Value
The lowest PSA value from the start of study therapy.
Time frame: 1 year, 2 years
Percentage of Participants With Biochemical Progression-free Survival (BPFS)
Disease progression defined as Phoenix RTOG definition of nadir PSA + 2ng/ml or initiation of salvage therapy not imaging. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.
Time frame: 36 and 48 months
Metastasis or Systemic Therapy
Time to either imaging indicating metastasis or beginning a new systemic therapy. This is a distinctly different measure from number 4 above. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.
Time frame: up to 5 years (60 months)
Testosterone Recovery
Time to testosterone recovery
Time frame: up to 5 years
PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
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5 mg tablet once daily for 6 months.
Percentage of men with 1, 2, 3, 4 and 5 year PSA \< 1.5ng/ml in setting of non-castrate testosterone.
Time frame: 1 year, 2 years, 3 years, 4 years, 5 years
Safety and Tolerability
The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0.
Time frame: 6 months