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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


Phase 2
N/A
N/A
Open (Enrolling)
Male
Prostatic Neoplasms

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Rate of biochemical recurrence

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Choung-Soo Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Urology,Asan Medical Center, Seoul

Authority:

Korea: Institutional Review Board

Study ID:

AMC-PC2012002

NCT ID:

NCT01759836

Start Date:

October 2012

Completion Date:

October 2015

Related Keywords:

  • Prostatic Neoplasms
  • Prostatectomy
  • Statins
  • Neoplasms
  • Prostatic Neoplasms

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