Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

Recruiting Phase 2 Interventional Study
Metastatic Castration-resistant Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Other
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About This Trial
The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alter…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Performance status ≤2. * Documented histologically confirmed adenocarcinoma of the prostate. * Baseline PSA ≥1.0 ng/ml. * No prior androgen deprivation therapy (i.e. surgical castration LHRH agonist, LHRH antagonist) as treatment for biochemically recurrent or…
Contacts

Rana Sullivan, RN

410-614-6337

tomalra@jhmi.edu

CONTACT

Donna Bieg, RN

410-502-7625

dbieg2@jh.edu

CONTACT