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HMG-CoA Reductase Inhibitor

Atorvastatin for Prostate Adenocarcinoma

Phase 2

Waitlist Available

Led By Chad Tang

Research Sponsored by M.D. Anderson Cancer Center

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 12 months

Awards & highlights

Study Summary

This study is evaluating whether a combination of drugs may help improve erectile dysfunction in prostate cancer patients.

Eligible Conditions

Prostate Adenocarcinoma
Erectile Dysfunction

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in International Index of Erectile Function (IIEF) Scores

Secondary outcome measures

Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)

Number of Participants With Incidence of Adverse Events (AEs)

Other outcome measures

Baseline patient features

Side effects data

From 2014 Phase 3 trial • 58 Patients • NCT02084069

Postoperative bleeding

100%

80%

60%

40%

20%

Study treatment Arm

Treatment

Control

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (atorvastatin, vitamin E, pentoxifylline)Experimental Treatment3 Interventions

Patients receive atorvastatin PO QD for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Beginning week 7, patients receive atorvastatin PO QD, vitamin E PO QD, and pentoxifylline PO TID for up to 12 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin E Compound

2019

Completed Phase 2

~20

Atorvastatin

FDA approved

Pentoxifylline

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,976 Previous Clinical Trials

1,789,494 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,357 Total Patients Enrolled

Chad TangPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

495 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Atorvastatin been federally recognized as a safe medication?

"While there is some data supporting the safety of Atorvastatin, it did not demonstrate efficacy in clinical trials and thus received a score of 2."

Answered by AI

How many people total will be included in this research project?

"As of right now, this clinical trial is not recruiting patients. This study began on November 20th, 2019 and was last updated on October 6th, 2020. There are currently 148 other trials looking for patients with erectile dysfunction and 86 studies searching for participants that take Atorvastatin."

Answered by AI

Does this research project break new ground?

"At the time of this writing, 86 different medical studies are using Atorvastatin. These trials are being conducted in 167 cities and 30 countries. The first trial occurred in 2005 and was sponsored by Merck Sharp & Dohme LLC. Only 80 patients were involved in this Phase 4 drug approval stage study. In the 15 years since then, 517 similar studies have completed."

Answered by AI

What is the primary reason that doctors prescribe Atorvastatin?

"Atorvastatin is a common medication used to lipidemias. However, it can also be helpful in managing postoperative thromboembolism, anginal pain, and transient ischemic attack."

Answered by AI

Are there still positions available for individuals in this research project?

"Although this study is not currently looking for more participants, it was originally posted on 20 November 2019. The most recent edit to the trial was made on 6 October 2020. For those still exploring their options, there are 148 clinical trials actively recruiting patients with erectile dysfunction and 86 Atorvastatin trials enrolling participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer

2019. "Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03830164.