Prostate Cancer Clinical Trial
Official title:
Pharmacodynamic Trial of Pre-Prostatectomy Lovastatin on MYC (V-myc Myelocytomatosis Viral Oncogene Homolog) Down-Regulation in Localized Prostate Cancer
To determine the dose of continuous daily oral lovastatin needed to achieve MYC [v-myc myelocytomatosis viral oncogene homolog (avian)] down-regulation in prostatectomy specimens in intermediate-/high-risk localized prostate cancer patients.
Pharmacodynamic Phase 0 trial of pre-prostatectomy lovastatin to downregulate MYC in
localized prostate cancer.
Rationale: Based on available clinical and preclinical data, the investigators theorize that
high-dose lovastatin therapy will decrease MYC levels in human prostate cancers shown to have
MYC overexpression on biopsy.
Experimental Methods: The investigators propose a prospective, dose-finding pharmacodynamic
study of lovastatin in intermediate/high-grade localized prostate cancer. The study will
involve 30 eligible patients with localized prostate cancer with a Gleason sum of 7 to 10 who
elect to undergo prostatectomy at Johns Hopkins. Five eligible men will be scheduled to
receive oral lovastatin following a four times a day schedule, at the starting dose of 12
mg/kg/day. Patients will receive 2 weeks (14 days) of daily oral lovastatin prior to surgery.
Following an initial safety monitoring period of a month, the investigators enroll at the
next dose level (20 mg/kg/day). Similar dose de-escalation will continue over three more dose
levels (1, 4 and 8 mg/kg/day) until 25 patients total are enrolled. Following surgery,
prostatectomy specimens will undergo MYC immunohistochemistry (IHC) and compared to MYC IHC
from matched biopsy samples. Pharmacodynamic efficacy (PE) will be defined as greater than
60% inhibition of MYC expression by IHC in greater than 60% of patients in prostatectomy
tumor specimens compared to the matched biopsy.
Expected Results: The investigators expect lovastatin will enforce the downregulation of MYC
levels in prostatectomy samples as compared to pre-lovastatin treatment core biopsy samples.
The investigators also expect little toxicity to patients as reported in prior phase I and II
trials using similar doses of lovastatin.
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