Clinical trial NCT01759836: Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: Prostatectomy
Statins
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Dong-A Pharmaceutical
First posted: 2013-01-03
Enrollment: 364
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of biochemical recurrence
timeFrame: One year
Secondary outcomes:
measure: Biochemical recurrence free survival
timeFrame: Five years
Other outcomes:
measure: Clinical progression-free survival
timeFrame: Five years
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Department of Urology,Asan Medical Center, Seoul
name: Choung-Soo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeong IG, Lim B, Yun SC, Lim JH, Hong JH, Kim CS. Adjuvant Low-dose Statin Use after Radical Prostatectomy: The PRO-STAT Randomized Clinical Trial. Clin Cancer Res. 2021 Sep 15;27(18):5004-5011. doi: 10.1158/1078-0432.CCR-21-0480. Epub 2021 May 19.