Atorvastatin Calcium in Preventing Metabolic Syndrome in Prostate Cancer Patients Receiving Androgen-Deprivation Therapy

NCT01555632 | Withdrawn DMC

• 3 other identifiers: 0429-11-FBNCI-2012-00046P30CA036727
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized pilot clinical trial studies atorvastatin calcium in preventing metabolic syndrome in patients with prostate cancer receiving long-term androgen-deprivation therapy. Atorvastatin calcium may help prevent or reduce metabolic syndrome caused by long-term androgen-deprivation therapy

Conditions

Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Overall change of metabolic syndrome score (divided into 6 groups according to the number of constituents [0-5] of metabolic syndrome)

  A total of 60 subjects will yield 80% power at the 0.05 two-sided level of significance to detect 3.40 difference of the mean change in metabolic syndrome scores after 6 months between arms using a Mann-Whitney test.

  At 6 months

• Change in effectiveness of atorvastatin calcium on the prevention of metabolic syndrome

  The overall change of metabolic syndrome score is evaluated in men undergoing or who have undergone androgen-deprivation therapy for treatment or the control of prostate cancer.

  At 3 and 6 months

Secondary Outcomes (3)

• Change in Safety and tolerability of atorvastatin calcium

  Adverse Events (AE) at 3 and 6 months

• Impact of atorvastatin calcium on mean change in PSA and PSA velocity

  At 3 and 6 months

• Optional collection and banking of blood and serum on subjects for future analysis

  Number of samples collected at baseline and then at 3 and 6 months

Study Arms (2)

Arm I (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity.

Drug: placebo

Arm II (atorvastatin calcium)

EXPERIMENTAL

Patients receive atorvastatin calcium PO QD for 6 months in the absence of disease progression or unacceptable toxicity.

Drug: atorvastatin calcium

Interventions

atorvastatin calcium DRUG

Given PO

Also known as: CI-981, Lipitor

Arm II (atorvastatin calcium)

placebo DRUG

Given PO

Also known as: PLCB

Arm I (placebo)

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed prostate cancer, any stage disease allowed Androgen deprivation for treatment or control of prostate cancer including any of the following:
• Bilateral orchiectomy
• Luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide, goserelin, bicalutamide, flutamide, or similar agents) with or without antiandrogen therapy
• No statin therapy, antihyperlipidemic, lipid-lowering medications, HMG-COA reductase inhibitor, atorvastatin calcium, or LIPITOR ® use
• Patients must be willing to give written informed consent, and sign an institutionally approved consent form before performance of any study-related procedure not part of normal medical care based on current diagnosis and clinical condition, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
• Karnofsky Performance Status \>= 70
• Able to adhere to the study visit schedule and other protocol requirements
• No serious disease or condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study
• Absolute neutrophil count (ANC) \>= 1000 cells/mm\^3
• Platelet Count \>= 100 mm\^3
• Serum creatinine \< 2.0 mg/dL
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \< 2 x the upper limits of normal
• Hepatic alkaline phosphatase \< 2 x the upper limits of normal

You may not qualify if:

• Treatment with a cytotoxic chemotherapy or participation in any other studies involving investigational or marketed products, concomitantly within 30 days before Day 1 of study treatment; palliative radiation therapy is allowed
• Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C or active Hepatitis
• Known alcohol and/or any other drug abuse
• History of intolerance or hypersensitivity to statins and known hypersensitivity to atorvastatin
• Known history of non-low-density lipoprotein (LDL) cholesterol \> 150 mg/dL, peripheral artery disease, coronary heart disease, myocardial infarction (MI) or angina, coronary artery disease or diabetes (as should be receiving statin therapy per current standards); in addition, patients with a known history of smoking, hypertension, family history of myocardial events, and non-LDL \> 100 mg/dL
• Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) as assessed by the investigator
• Known cerebrovascular accidents within 6 months before Day 1 of study treatment
• Treatment with drugs not permitted by the study protocol or the likelihood of requiring treatment during the study period with drugs which might interfere with the absorption and evaluation of study drugs during the study protocol
• Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Atorvastatin

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)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Jue Wang, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: March 15, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 14, 2023

Record last verified: 2023-08