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Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer

This study is ongoing, but not recruiting participants.
Rutgers Cancer Institute of New Jersey
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey Identifier:
First received: October 13, 2010
Last updated: July 20, 2016
Last verified: July 2016

RATIONALE: Atorvastatin calcium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atorvastatin calcium together with celecoxib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving atorvastatin calcium together with celecoxib works in treating patients with rising PSA levels after local therapy for prostate cancer.

Condition Intervention Phase
Prostate Cancer
Drug: atorvastatin calcium
Drug: celecoxib
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.

Resource links provided by NLM:

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • PSA response [ Time Frame: up to 2.5 years (6 months therapy and 2 years of follow-up) ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: February 2009
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin and Celecoxib Drug: atorvastatin calcium Drug: celecoxib Other: laboratory biomarker analysis

Detailed Description:



  • To determine the effect on the biological activity, as assessed by prostate-specific antigen (PSA) response, of atorvastatin calcium and celecoxib in patients with D0 prostate cancer.


  • To document the safety and feasibility of atorvastatin calcium and celecoxib in patients with early-stage prostate cancer.
  • To evaluate the effects of the combination of atorvastatin calcium and celecoxib on nuclear factor-kB (NFkB), extracellular signal-regulated kinase (ERK), prostaglandin E2 (PGE2), and IL6 in peripheral blood mononuclear cells (PBMC).

OUTLINE: This is a multicenter study.

Patients receive oral atorvastatin calcium once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients may undergo blood sample collection at baseline and after completion of study therapy for correlative studies.

After completion of study therapy, patients are followed up every 3 months for 2 years.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed prostate cancer

    • Stage D0 disease

      • Tumor originally diagnosed as being limited to the prostate and now having a rising prostate-specific antigen (PSA) after definitive local therapy
  • Must have undergone local treatment via prostatectomy or radiotherapy

    • PSA values must be ≥ 0.2 ng/mL as determined by 2 measurements, ≥ 1 month apart and ≥ 6 months after prostatectomy
    • PSA values must be ≥ 2.0 ng/mL as determined by 2 measurements, ≥ 1 month apart and ≥ 6 months after radiotherapy
    • The first two PSA values along with a third value must all be rising (i.e., there must be an overall rising trajectory, such that the third value cannot be lower than the first value)
  • No metastatic disease by baseline bone scan and CT scan of the abdomen and/or pelvis


  • Life expectancy ≥ 6 months
  • ECOG performance status 0-2
  • WBC ≥ 3,500/µL
  • ANC ≥ 1,500/µL
  • Platelet count > 100,000/µL
  • Hemoglobin > 10 g/dL
  • Serum creatinine < 1.5 mg/dL OR creatinine clearance > 50 mL/min
  • Total bilirubin normal
  • SGOT and/or SGPT normal
  • No serious concomitant systemic disorder that, at the discretion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
  • No second primary malignancy within the past 5 years except adequately treated in situ carcinoma (e.g., non-melanomatous carcinoma of the skin) or other malignancy with no evidence of recurrence
  • No active clinically significant infection requiring antibiotics
  • No history of coronary artery disease
  • No myocardial infarction within the past 6 months
  • No sulfa allergy
  • No history of gastrointestinal bleeding


  • See Disease Characteristics
  • No prior hormone-ablative treatment

    • Prior neoadjuvant hormone-ablative therapy allowed provided it was completed ≥ 3 months ago
  • More than 4 weeks since prior herbal products with hormonal activity such as soy, saw palmetto, or PC-SPES
  • No prior or concurrent nonsteroidal anti-inflammatory drug (NSAIDS) for 7 consecutive days
  • No COX-2 inhibitor and/or statin within the past 6 months
  • No concurrent warfarin or any other anticoagulant, calcitriol, fibric acid derivatives, lipid-modifying doses of niacin, or strong cytochrome P450 3A4 inhibitors (e.g., cyclosporine, erythromycin, clarithromycin, and azole antifungals) or inducers (e.g., St John wort)
  • No other concurrent anticancer agents or therapies including chemotherapy, hormonal therapy, radiotherapy, or experimental therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01220973

United States, Michigan
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
United States, New Jersey
Cooper Hospital
Camden, New Jersey, United States, 08103
Robert Wood Johnson University Hospital at Hamilton
Hamilton, New Jersey, United States, 08690
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Rutgers Cancer Institute of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Susan Goodin, PhD, FCCP, BCOP Rutgers Cancer Institute of New Jersey
  More Information

Responsible Party: Rutgers, The State University of New Jersey Identifier: NCT01220973     History of Changes
Other Study ID Numbers: 080811  0220090006  NCI-2012-00540 
Study First Received: October 13, 2010
Last Updated: July 20, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
stage IV prostate cancer
stage III prostate cancer
recurrent prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Calcium, Dietary
Atorvastatin Calcium
Bone Density Conservation Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on January 17, 2017