Pre-Prostatectomy Lovastatin on Prostate Cancer

NCT01478828 | Terminated Results DMC

• 2 other identifiers: J1153NA_00048234
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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-/high-risk localized prostate cancer patients.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Can Achieve 60% MYC Modulation Response

  Number of participants who achieve V-myc Myelocytomatosis Viral Oncogene Homolog (MYC) down-regulation in prostatectomy specimens in intermediate-/high-risk localized prostate cancer patients.

  1 year

Secondary Outcomes (7)

• Number of Participants Who Experience Specific Adverse Events at Different Dosing Points Prior to Surgery.

  1 year

• Proportion of Men With MYC Target Inhibition in Prostate Tumor Tissue

  1 year

• Change in Cholesterol Level After Lovastatin Treatments.

  1 year

• Pharmacodynamic Changes in Participants After the Pre-treatment Biopsy as Measured by Number of Participants With Target Inhibition of MYC

  1 year

• Number of Participants With Target Inhibition of MYC and Increased Apoptosis and Proliferation

  1 year

Study Arms (1)

Lovastatin

EXPERIMENTAL

After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.

Drug: Lovastatin

Interventions

Lovastatin DRUG

oral qd varying dose escalations/de-escalations

Also known as: Altoprev®; Mevacor®

Lovastatin

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Patrick C Walsh Prostate Cancer Research Fund: collaborator

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lovastatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Phuoc Tran
• Organization: The SKCCC at Johns Hopkins

tranp@jhmi.edu

410-614-6477

Study Officials

• Phouc Tran, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 23, 2011
• Study Start: July 13, 2012
• Primary Completion: April 8, 2013
• Study Completion: April 8, 2013
• Last Updated: March 27, 2019
• Results First Posted: November 9, 2015

Record last verified: 2019-03

Locations

US (1)