Your session is about to expire
← Back to Search
Statins for Prostate Cancer
Phase 2
Recruiting
Led By Michael Marrone, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial will test if statins can reduce tumor growth in prostate cancer patients by boosting the body's immune system. Half the patients will get statins 8 weeks before surgery.
Who is the study for?
This trial is for men with intermediate to high-risk localized prostate cancer who are planning a prostatectomy. They must not have used statins in the past year, have no history of severe reactions to statins, no metastases or diabetes, normal liver function and cholesterol levels above 50mg/dL, and not be on certain other medications.Check my eligibility
What is being tested?
The study tests if simvastatin can alter immune responses within the prostate by affecting T-reg cells in men undergoing surgery for prostate cancer. Participants will either receive simvastatin for 8 weeks before their operation or follow standard care without statins.See study design
What are the potential side effects?
Simvastatin may cause muscle pain or weakness (myopathy), liver issues, digestive problems like constipation or nausea, headaches, and an increased risk of diabetes. It's important that participants don't already have conditions that could worsen these side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intra-prostatic YAP-mediated T-reg dysfunction in total tissue area
Secondary outcome measures
Intra-prostatic YAP-mediated T-reg dysfunction, limited to T-regs in adjacent normal and stromal tissue
Neoplasms
Intra-prostatic anti-tumor immune response
Side effects data
From 2012 Phase 4 trial • 87 Patients • NCT015678267%
Hospitalization
7%
Periprocedural complications
7%
Statin dose reduction
2%
Creatine kinase-MB > 5x ULN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aggressive Lipid Therapy
Standard of Care Lipid Therapy
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SimvastatinExperimental Treatment1 Intervention
Patients randomized to the statin group will receive 40 mg oral simvastatin QD for eight weeks prior to prostatectomy, including the day of surgery.
Group II: ControlActive Control1 Intervention
Patients randomized to the control group receive no intervention prior to prostatectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Simvastatin 40mg
2018
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,599 Total Patients Enrolled
18 Trials studying Prostate Cancer
743 Patients Enrolled for Prostate Cancer
Michael Marrone, PhDPrincipal InvestigatorPublic Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication to lower my cholesterol.I am a man with prostate cancer at intermediate or high risk of recurrence.My LDL cholesterol is below 50mg/dL.I am currently taking medications that interact with simvastatin.I have taken statins in the last year.My cancer has spread or might have spread to other parts of my body.I have not had any cancer other than non-melanoma skin cancer in the past 2 years.I have diabetes or am on diabetes medication.I have had a heart attack or stroke in the past.I have had chemotherapy, hormone therapy, or radiation before surgery or as an initial treatment.I have a history of muscle disease with high creatine kinase levels.I have chronic liver disease or my liver tests are higher than normal.I stopped taking statins due to side effects.My kidney function is severely reduced.I have chosen to have surgery to remove my prostate.I am not taking any medications that can't be used with simvastatin.
Research Study Groups:
This trial has the following groups:- Group 1: Simvastatin
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any available positions in this investigation?
"According to clinicaltrials.gov, this trial is still accepting participants. First advertised on the 19th of October 2022, the study was last edited a month later on November 30th."
Answered by AI
Has Simvastatin been certified by the FDA?
"There is a reasonable amount of evidence backing Simvastatin's safety, so Power awarded it a rating of 2. However, as this trial has only reached Phase 2, there are no reports on the drug's efficacy yet."
Answered by AI
What is the enrollment size of this trial?
"That is correct. According to the information posted on clinicaltrials.gov, this study initiated recruitment on October 19th 2022 and was recently updated November 30th of that same year. It requires 36 participants from one particular medical centre."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger