Status and phase
Conditions
Treatments
About
The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent, uniform across the US and indifferent to race. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.
But with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, African Americans with prostate cancer fared as well if not better than Caucasians and importantly had better outcomes with abiraterone, an observation needing further exploration as these therapies move up front.
Enrollment
Sex
Volunteers
Inclusion criteria
Veterans must meet the following to be eligible to participate:
Be willing and able to provide written informed consent for the trial.
Age ≥18 years of age on day of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet-cell features, or small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.
Have been receiving or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).
High risk for the development of progression of disease/metastasis, defined as (i) a minimum of three rising PSA values (PSA1 < PSA2 < PSA3) at an interval of at least 1 week apart; (ii) a PSA level of 2 ng per milliliter (2 μg/L) or greater; and (iii) a PSA doubling time of 9 months or less during continuous androgen-deprivation therapy (bilateral orchiectomy or treatment with gonadotropin-releasing hormone analogue agonists or antagonists) as calculated with the use of the method of Pound et al.
Has not received abiraterone acetate, enzalutamide, or apalutamide at the time of enrollment.
Have a predicted life expectancy of >12 months.
For patients receiving bisphosphonates or denosumab, dose must be stable for at least 4 weeks before randomization.
Able to swallow the study drug and comply with study requirements.
Laboratory tests meet minimum safety requirements:
Exclusion criteria
Subjects with any of the following will not be enrolled:
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups
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Central trial contact
Ta-Chueh Rosenberg; Tito Fojo, MD, PhD
Data sourced from clinicaltrials.gov
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