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AGE Inhibitors for Prostate Cancer

Phase 2
Waitlist Available
Led By Michael Lilly, MD
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
Subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows: Hematology parameters: ANC >1000/mcL, platelets > 100,000/mcL, Hgb >8.0gm/dL Renal Function: eGFR of > 45mls/min using Cockgroft and Gault formula (see appendix C). Liver Function: Total bilirubin ≤ULN, AST and ALT <1.5xULN Able to swallow and retain oral medication ECOG performance status of 0 - 2 Ability to sign written informed consent Testosterone level <50ng/dL
Confirmation of adenocarcinoma of the prostate that is documented by one of the following: pathology report or clinic note with documented history of prostate cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 85 days
Awards & highlights

Study Summary

This trial is testing if a drug can lower amounts of a substance linked with cancer progression in men with prostate cancer.

Who is the study for?
This trial is for men with prostate cancer confirmed by pathology report or history, currently on ADT with low testosterone levels. They can have had prior chemotherapy or targeted therapy but must not be taking strong antioxidants or have allergies to grapes/grape seed.Check my eligibility
What is being tested?
The study is examining the effects of a drug called OPC on AGE levels in prostate cancer patients who are undergoing Androgen Deprivation Therapy (ADT). It aims to understand how OPC influences these levels and potentially affects the disease.See study design
What are the potential side effects?
While specific side effects of OPC aren't detailed here, common ones may include digestive issues, blood sugar changes due to metformin, and potential allergic reactions for those sensitive to ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer diagnosis is confirmed by a pathology report or doctor's note.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~85 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 85 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AGE level reduction
Secondary outcome measures
Correlation between AGE levels and c-reactive protein (CRP)
Correlation between AGE levels and leptin
Correlation between AGE levels and malondialdehyde (MDA)
+12 more

Side effects data

From 2011 Phase 1 trial • 6 Patients • NCT02169427
33%
Somnolence
17%
Headache
17%
Wound
17%
Frequent Bowel Movements
100%
80%
60%
40%
20%
0%
Study treatment Arm
Opicapone (OPC)

Trial Design

1Treatment groups
Experimental Treatment
Group I: OPCExperimental Treatment2 Interventions
Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,219 Total Patients Enrolled
18 Trials studying Prostate Cancer
738 Patients Enrolled for Prostate Cancer
Michael Lilly, MDPrincipal InvestigatorMedical University of South Carolina
9 Previous Clinical Trials
173 Total Patients Enrolled
4 Trials studying Prostate Cancer
85 Patients Enrolled for Prostate Cancer

Media Library

OPC (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02946996 — Phase 2
Prostate Cancer Research Study Groups: OPC
Prostate Cancer Clinical Trial 2023: OPC Highlights & Side Effects. Trial Name: NCT02946996 — Phase 2
OPC (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02946996 — Phase 2

Frequently Asked Questions

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

Are there any prior experiments utilizing OPC that can inform the current study?

"Currently, there are 170 medical trials studying OPC; with 43 of these studies in the Phase 3 stage. While Pittsburgh, Pennsylvania serves as the hub for these experiments, 1902 clinical sites across America have active research projects related to this treatment."

Answered by AI

Are there any remaining slots available to participants in this clinical experiment?

"Affirmative. Looking at the information on clinicaltrials.gov, it is clear that this medical trial commenced on December 28th 2016 and was recently updated on September 7th 2022. The team are currently looking to recruit 45 participants across a single site."

Answered by AI

How many participants have been recruited for this research endeavor?

"Affirmative, according to the information presented on clinicaltrials.gov, this medical trial is actively searching for participants; it was launched at the end of December 2016 and its most recent update occurred in September 2022. The research requires 45 people from a single location."

Answered by AI

What clinical conditions are commonly treated with OPC?

"OPC has been found to be an effective treatment for exercise-related injuries, and it is also used in the management of type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."

Answered by AI

Has OPC been certified by the FDA?

"Despite no clinical data on its efficacy, OPC has some supporting evidence for safety and is therefore rated as a 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
2016. "Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02946996.
~5 spots leftby Apr 2025
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