Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer

Asan Medical Center

Status and phase: Completed; Phase 2

Conditions: Prostatic Neoplasms

Treatments: Drug: Atorvastatin 20mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01759836

AMC-PC2012002

Details and patient eligibility

About

Biochemical recurrence develops in approximately 30-40% of men with locally advanced prostate cancer who undergo radical prostatectomy. To date, the effect of statins on prostate cancer recurrence has been investigated in several retrospective studies with inconsistent results. The purpose of this study is to determine the impact of statin on biochemical recurrence after radical prostatectomy for locally advanced prostate cancer.

Full description

Estimated Enrollment: 354

Study start date: October 2012

Estimated Study Completion Date: October 2015

Statin Group: Treatment with Atorvastatin 20mg daily after radical prostatectomy during 1 year.

Control Group: Treatment with Placebo daily after radical prostatectomy during 1 year.

Follow up: every 3 months for the first year. Check PSA, Total/LDL-cholesterol and Triglyceride.

Primary End Point Rate of Biochemical recurrence

Secondary End Point Clinical progression of prostate cancer Change of Total/LDL- cholesterol and Triglycerides 5 year-Biochemical recurrence free survival

Enrollment: 364 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must have correspond to one of the following three pathologic criteria.

   A. Gleason scores 8 or greater B. Positive resection margin C. pT3-T4

2. Patients must have pathologically adenocarcinoma

3. Patients must be enrolled within 60 days after radical prostatectomy

4. Patients must be able to provide written informed consent

Exclusion criteria

1. Patients who have received neoadjuvant androgen deprivation therapy
2. Patients who have the participation of other clinical trial within the past 3 months
3. Patients who have treated with statin
4. Patients who have lymph node metastasis or distant metastasis
5. Patients who have 10 year risk of cardiovascular disease over 10% based on NCEP ATP III guideline.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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364 participants in 2 patient groups, including a placebo group

Atorvastatin 20mg

Experimental group

Description:

Atorvastatin 20mg daily for 1 year

Treatment:

Drug: Atorvastatin 20mg

Placebo

Placebo Comparator group

Description:

Placebo daily for 1 year

Treatment:

Drug: Atorvastatin 20mg