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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
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patient receiving abiraterone then enzalutamide would receive retreatment with enzalutamide post-BAT).Patients must be withdrawn from enzalutamide or abiraterone acetate for equal to 4 weeks and have documented PSA increase after the withdrawal period.Patients receiving prednisone in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
11/26/2014 04:10 AM

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