Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin 20mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Atorvastatin 20mg
- description
- Atorvastatin 20mg daily for 1 year
- interventionNames
- Drug: Atorvastatin 20mg
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo daily for 1 year
- interventionNames
- Drug: Atorvastatin 20mg
Primary outcomes (1)
- measure
- Rate of biochemical recurrence
- timeFrame
- One year
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDJeong 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. PMID 34011557