Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSun Pharmaceutical Industries Limited
About this trial
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 and uniform across the US. 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, all men with prostate cancer fare comparably well. As our sophistication in categorizing cancers molecularly has increased this study will look to better examine any emerging differences across study participants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 2 or less (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 morphologic evidence of small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.
Disqualifiers
Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide or darolutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo).
Treatment with hormonal therapy (e.g., androgen receptor inhibitors other than bicalutamide, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist therapy) within 4 weeks of randomization.
History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).
Patients who are receiving any other investigational agents concurrently.
Trial design
Design model
Parallel
Treatments tested in this trial
Abiraterone acetate
DrugYONSA® (fine particle formulation abiraterone acetate), YONSA® 500 mg (four 125 mg tablets) or 625 mg (five 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\]. Note that in the first four months the YONSA® dose should not exceed 500 mg administered orally once daily. ZYTIGA® (abiraterone acetate) or generic ZYTIGA 1000 mg (four 250 mg uncoated tablets or two 500 mg film-coasted tablets) administered orally once daily in combination with prednisone 5 mg administered orally once daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\].
Apalutamide
DrugApalutamide (ERLEADA®), 240 mg (four 60 mg tablets) administered orally once daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\].
Enzalutamide
DrugEnzalutamide (XTANDI®), 160 mg (four 40 mg capsules) administered orally once daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\].
Treatment groups
192 Participants
are divided into 2 treatment groupsGroup A: Abiraterone AcetateActive comparator 1 intervention
Group B: Standard of CareActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Tumor growth rate (g)
Tumor growth rate (g)
Time frame
2 years2
Testosterone levels
Testosterone levels to assess testosterone suppression with androgen deprivation therapy (ADT).
Time frame
2 yearsSecondary outcomes
1
PSA Response
PSA response based Prostate Cancer Working Group 2 guidelines.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sun Pharmaceutical Industries Limited
Lead sponsor
VA Puget Sound Health Care System
Collaborator
VA Greater Los Angeles Healthcare System
Collaborator
James A. Haley Veterans Administration Hospital
Collaborator
VA New York Harbor Healthcare System
Collaborator
VA Ann Arbor Healthcare System
Collaborator
Corporal Michael J. Crescenz VA Medical Center
Collaborator
W.G. Bill Hefner Medical Center
Collaborator
Portland VA Medical Center
Collaborator
Michael E. DeBakey VA Medical Center
Collaborator
VA St. Louis Health Care System
Collaborator
VA Hudson Valley HealthCare System
Collaborator
Source ClinicalTrials.gov