Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-90
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About this trial
Asymptomatic men without pain due to prostate cancer progressing with metastatic CRPC after treatment with combination or sequential ADT + Abi will be treated on a randomized, open label study to determine if sequential treatment with high dose T and Enza will improve primary and secondary objectives vs. continuous Enza as standard therapy.
Eligibility criteria
Qualifiers
ECOG Performance status ≤2.
Age ≥18 years.
Histologically-confirmed adenocarcinoma of the prostate.
Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist).
Disqualifiers
Pain due to metastatic prostate cancer requiring treatment intervention with pain medication.
ECOG Performance status ≥3
Prior treatment with enzalutamide is prohibited.
Prior chemotherapy with docetaxel or cabazitaxel for castration resistant prostate cancer is prohibited.
Trial design
Treatments tested in this trial
- Testosterone cypionate
- Enzalutamide
- Testosterone enanthate
Treatment groups
150 Participants
are divided into 3 treatment groupsLocations
6California
University of California, San Diego (UCSD)92037, San Diego United States
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center21287, Baltimore United States
Massachusetts
Dana-Faber Cancer Institute02215, Boston United States
Minnesota
University of Minnesota55455, Minneapolis United States
Sponsors and collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov