Pre-Prostatectomy Lovastatin on Prostate Cancer

• Status: Terminated
• Trial end date: 2013-04-08
• Target enrollment: 0
• Participant gender: Male

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-/high-risk localized prostate cancer patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Patrick C Walsh Prostate Cancer Research Fund
• Treatments: Dihydromevinolin; L 647318; Lovastatin

Criteria

Inclusion Criteria:

1. Adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs, stage T1c or higher.

2. 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).

3. Age ≥18 years of age.

4. Radical prostatectomy scheduled at Johns Hopkins.

5. Willingness to sign and ability to understand informed consent.

6. No history of treatment with any statin-class medication within 6 months of entry into the trial.

7. ECOG (Eastern Cooperative Oncology Group) performance status 0-1.

8. 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 Criteria:

1. Patients with evidence of metastatic prostate cancer, including bone, visceral, brain, and lymph node metastases.

2. Other histologic prostate cancers, including ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors.

3. 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.

4. Concurrent malignancy other than prostate cancer.

5. Inability to provide informed consent.

6. Concomitant use of azole antifungals, cyclosporine, clarithromycin, erythromycin, fibric acid derivatives, lopinavir/ritonavir, niacin, ritonavir/saquinavir

7. Prior chemotherapy, radiation therapy, biologic therapy, or immunotherapy for prostate cancer.

8. Poor performance status (ECOG >1).

9. Prostatectomy at other hospital other than Johns Hopkins.

10. Prior history of allergy or severe reaction to statins or statin derivatives.