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 groupsSponsors and collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov