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

A Randomized Double Blind, Placebo-controlled Study Determining the Role of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01759836

Enrollment

364

Registered

2013-01-03

Start date

2012-10-31

Completion date

2021-09-30

Last updated

2022-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Keywords

Prostatectomy, Statins

Brief summary

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.

Detailed 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

Interventions

DRUGAtorvastatin 20mg

Atorvastatin 20mg daily for 1 year

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

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.

Design outcomes

Primary

Measure	Time frame
Rate of biochemical recurrence	One year

Secondary

Measure	Time frame
Biochemical recurrence free survival	Five years

Other

Measure	Time frame
Clinical progression-free survival	Five years

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026