Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-28 @ 7:54 AM
Study NCT ID:
NCT01555632
Status:
WITHDRAWN
Last Update Posted:
2023-08-14
First Post:
2012-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atorvastatin Calcium in Preventing Metabolic Syndrome in Prostate Cancer Patients Receiving Androgen-Deprivation Therapy
Sponsor:
University of Nebraska
Organization:
Study Overview
Official Title:
A Pilot Study of Atorvastatin on Prevention of Metabolic Syndrome in Subjects With Prostate Cancer on Long Term Androgen-deprivation Therapy
Status:
WITHDRAWN
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Other more favorable treatments are now available.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-00046 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P30CA036727 | NIH | None | https://reporter.nih.gov/quic… | View |