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Withdrawn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
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Prostate Cancer
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of normal medical care based on current diagnosis and clinical condition, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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
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
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.
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
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.
Time Frame
Adverse Events (AE) at 3 and 6 months
Title
Impact of atorvastatin calcium on mean change in PSA and PSA velocity
Description
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.
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
No
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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