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OpenTrials
Completed

NCT Number: NCT01759836

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

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Patients must have pathologically adenocarcinoma
  • Patients must be enrolled within 60 days after radical prostatectomy
  • Patients must be able to provide written informed consent

Exclusion criteria

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

Treatment and study plan

Atorvastatin 20mg

Drug

Atorvastatin 20mg daily for 1 year

Primary outcomes

  1. Rate of biochemical recurrence

    Time frame: One year

Secondary outcomes

  1. Biochemical recurrence free survival

    Time frame: Five years

Other outcomes

  1. Clinical progression-free survival

    Time frame: Five years

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Dong-A Pharmaceutical

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Jan 3, 2013
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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