Status:
TERMINATED
Pre-Prostatectomy Lovastatin on Prostate Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Patrick C Walsh Prostate Cancer Research Fund
Conditions:
Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
NA
Brief Summary
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-/hi...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs, stage T1c or higher.
- Tumor Gleason sum of 7 (4+3 and 3+4 allowed) in at least one core, after central review of prostate biopsy at Johns Hopkins. However, in accordance with standard clinical practices, adenocarcinoma must be present in at least two discrete biopsy sections ( may vary in Gleason score).
- Age ≥18 years of age.
- Radical prostatectomy scheduled at Johns Hopkins.
- Willingness to sign and ability to understand informed consent.
- No history of treatment with any statin-class medication within 6 months of entry into the trial.
- ECOG (Eastern Cooperative Oncology Group) performance status 0-1.
- Adequate bone marrow, hepatic, and renal function as determined by:
- WBC (white blood cells) \>3,500 cells/mm3 ANC (absolute neutrophil count) \>1,500 cells/mm3 Hemoglobin \>9 g/dl Platelet count \>100,000 cells/mm3 Serum creatinine \< 2.6 mg/dl Serum bilirubin \<2 mg/dl ALT (alanine aminotransferase), AST (aspartate aminotransferase), and Alkaline Phosphatase \<2 times the upper limit of normal Triglycerides and total cholesterol \<3 times the upper limit of normal
Exclusion
- Patients with evidence of metastatic prostate cancer, including bone, visceral, brain, and lymph node metastases.
- Other histologic prostate cancers, including ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors.
- Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy including active liver disease, unexplained persistent elevation of serum transaminases, or medications that interfere with the metabolism of lovastatin, or gastrointestinal disease that would limit the ability to swallow or take oral medications or absorb them.
- Concurrent malignancy other than prostate cancer.
- Inability to provide informed consent.
- Concomitant use of azole antifungals, cyclosporine, clarithromycin, erythromycin, fibric acid derivatives, lopinavir/ritonavir, niacin, ritonavir/saquinavir
- Prior chemotherapy, radiation therapy, biologic therapy, or immunotherapy for prostate cancer.
- Poor performance status (ECOG \>1).
- Prostatectomy at other hospital other than Johns Hopkins.
- Prior history of allergy or severe reaction to statins or statin derivatives.
Key Trial Info
Start Date :
July 13 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01478828
Start Date
July 13 2012
End Date
April 8 2013
Last Update
March 27 2019
Active Locations (1)
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1
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231