Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 alternating therapy.
This research is being done to determine if alternating high dose testosterone and prevent the development of resistance to hormone therapy. It is also being done to determine if this alternating therapy can decease the side effects of hormone therapy and improve the participant's quality of life. Right now, patients who develop metastatic prostate cancer are treated with medications that block testosterone effects as first-line therapy. Eventually, the testosterone blocking therapies become ineffective and the tumor begins to grow. The investigaors call this phase of the disease castrater-re…
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 metastatic disease (may have received neoadjuvant, concurrent and/or adjuvant AD therapy in the context of definitive radiation therapy if it was administered ≥ 1 year prior to recurrence). * No prior treatment with ARPI (abiraterone, enzalutamide, darolutamide) for biochemically recurrent or metas…
Intermittent intramuscular testosterone cypionate (T) at a dose of 400 mg every 4 weeks.
Eligible patients will initiate combined androgen deprivation therapy (ADT) with an LHRH agonist or antagonist (e.g. Eligard, Zoladex, Lupron, Orgovyx) in combination with standard dose darolutamide (600 mg twice daily) for a total of 6 months.
600 mg twice daily during the lead-in phase and on darolutamide cycle.
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