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A Phase II Study to Determine Sequential Response to Bipolar Androgen Therapy (BAT) followed by Enzalutamide or Abiraterone Post-BAT in Men with Prostate Cancer Progressing on Combined Androgen Ablative Therapies RE-sensitizing with Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)
Protocol Number:
Phase II
Samuel Denmeade
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
1.) To determine the PSA response rate to Bipolar Androgen Therapy in men with Castrate Resistant Prostate Cancer who are post-abiraterone or post-enzalutamide.2.) To determine the PSA response rate to re-challenge with either abiraterone or enzalutamide post Bipolar Androgen Therapy.
Age equal to 18 yearsHistologically-confirmed adenocarcinoma of the prostateTreated with continuous androgen ablative therapy (either surgical castration or LHRH agonist)Documented castrate level of serum testosterone ( less than 20 ng/dl)Must have progressed on prior treatment with enzalutamide or abiraterone acetate + prednisone (by PSA criteria or radiographically).Patients with rising PSA on two successive measurements at least two weeks apartPrior treatment with up to 2 additional second line hormone therapies, including ketoconazole is allowed.Patients who have progressed on both enzalutamide and abiraterone acetate are eligible and post-BAT will be retreated with the last second line agent they had received (e.g. patient receiving abiraterone then enzalutamide would receive retreatment with enzalutamide post-BAT).Patients must be withdrawn from enzalutamide or abiraterone acetate for equal to 4 weeks and have documented PSA increase after the withdrawal period.Patients receiving prednisone in conjunction with abiraterone acetate must be weaned off prednisone prior to starting BAT.Acceptable routine labsAt least 4 weeks since prior surgery with full recovery (no persistent toxicity)Ability to understand and willingness to sign a written informed consent document.
Clinic visits every cycle (One time per month) for assessment of toxicity, vital signs and body composition.PSA every cycle. CT scan, bone scan at visit 4 and then every 3 months in BAT responders and and every 3 months in those responding to either Enza or Abi + PrednisoneQuality of life surveys at Visit 4 and every 3 months in BAT responders and at PB4 and every 3 months in in those responding to either Enza or Abi + Prednisone
Last Update
08/08/2020 05:02 AM