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

Primary Purpose

Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

atorvastatin calcium

placebo

About this trial

This is an interventional treatment trial for Recurrent Prostate Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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of normal medical care based on current diagnosis and clinical condition, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm I (placebo)

Arm II (atorvastatin calcium)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Change in Safety and tolerability of atorvastatin calcium

Safety will be assessed when approx 30 patients (50%) have completed the 3 month assessment based on the frequency and % of adverse events. 5 patients experiencing any non-hematologic, non-androgen deprivation related grade 3 or greater AE would trigger a systematic review of the AE experience. The frequency of AEs will be compared between the placebo and Atorvastatin groups using a Fisher's Exact test. A p-value of 0.20 will be considered significant for the interim assessment.

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

The effectiveness of Atorvastatin (atorvastatin calcium) on the prevention of metabolic syndrome is evaluated in men undergoing or who have undergone androgen-deprivation therapy for treatment or the control of prostate cancer.

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

Optional samples collected for future research that will be proposed in future IRB submissions.

Full Information

NCT ID

NCT01555632

First Posted

February 9, 2012

Last Updated

August 9, 2023

Sponsor

University of Nebraska

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01555632

Brief Title

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

Official Title

A Pilot Study of Atorvastatin on Prevention of Metabolic Syndrome in Subjects With Prostate Cancer on Long Term Androgen-deprivation Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Other more favorable treatments are now available.

Study Start Date

March 2012 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nebraska

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate in a pilot study a preliminary estimate of the overall change of metabolic syndrome score in men undergoing or who have undergone androgen-deprivation therapy for treatment or the control of prostate cancer. II. To assess the effectiveness of Atorvastatin (atorvastatin calcium) on the prevention of metabolic syndrome in men undergoing or who have undergone androgen-deprivation therapy for treatment or the control of prostate cancer. SECONDARY OBJECTIVES: I. To document the safety and tolerability of Atorvastatin in this patient population. II. To assess the impact of Atorvastatin on mean change in prostate specific antigen (PSA) and PSA velocity. III. The collection and banking of blood and serum on subjects for future analysis that will be proposed in future institutional review board (IRB) submissions. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive placebo orally once daily for 6 months in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive atorvastatin calcium orally once daily for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, and at 6 months thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (placebo)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Arm II (atorvastatin calcium)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

atorvastatin calcium

Other Intervention Name(s)

CI-981, Lipitor

Intervention Description

Given PO

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

PLCB

Intervention Description

Given PO

Primary Outcome Measure Information:

Title

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

Description

Time Frame

At 6 months

Title

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

Description

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.

Time Frame

At 3 and 6 months

Secondary Outcome Measure Information:

Title

Change in Safety and tolerability of atorvastatin calcium

Description

Time Frame

Adverse Events (AE) at 3 and 6 months

Title

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

Description

Time Frame

At 3 and 6 months

Title

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

Description

Optional samples collected for future research that will be proposed in future IRB submissions.

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jue Wang, MD

Organizational Affiliation

University of Nebraska

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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