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

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759836
• Other study ID #: AMC-PC2012002
• Status: Completed
• Phase: Phase 2
• Start date: October 2012
• Est. completion date: September 30, 2021

Study information

• Verified date: January 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Atorvastatin 20mg
Atorvastatin 20mg daily for 1 year

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Dong-A Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical progression-free survival		Five years
Primary	Rate of biochemical recurrence		One year
Secondary	Biochemical recurrence free survival		Five years