Prostate CancerPhase 2NCT02946996
Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
A Phase 2 study testing Metformin and OPC in people with Prostate Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to look at the effect that the study drug OPC has on AGE levels in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Metformin and OPC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2016to 19 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subjects must be receiving ADT with a GnRH agonist or antagonist, with or without an anti-androgen, with a current testosterone level documented to be <50ng/dL at enrollment. Subjects whose ADT is interrupted may enroll or continue on study as long as the testosterone is documented to remain <50ng/dL for the entire duration of study participation. Subjects who have undergone orchiectomy are also eligible.
- Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed.
- 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).
Show all 11Show fewer
- 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
Who cannot join
- Known allergy to grapes or grape seed
- History of receiving more than 2 classes of ADT.
- Current use of strong antioxidants (extracts from grape seed, milk thistle; pine bark, green tea, saw palmetto; resveratrol; flavonoids; catechins; ellagic acid), large quantities of red grapes, white button mushrooms, red wine. See section 4.7 for more details.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Randomized Phase II Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
The purpose of this study is to look at the effect that the study drug OPC has on AGE levels in patients with prostate cancer.
Read the detailed description
AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if Oligomeric Procyanidin Complex (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.
- Conditions
- Prostate Cancer
- Being tested
- Metformin, OPC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
OPCOther
OPC is a derivative of grape seed extract
| Study group | Role | What they receive |
|---|---|---|
| Metformin Only | Experimental | Subjects will be supplied with metformin tablets850mg. During the ramp up phase subjects will take metformin in the morning. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart. Receives: Drug: Metformin |
| OPC Only | Experimental | Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12. Receives: Other: OPC |
| Metformin plus OPC | Experimental | During week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about12 hours apart.
During weeks 2-12 the metformin tablet will betaken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening. Receives: Drug: Metformin; Other: OPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
AGE Level Reduction
The primary objective is to determine if any of the test agent are able to reduce AGE levels by an average of 30% (or greater) in 50% or more of test subjects.
Measured: 85 days
Secondary outcomes (15)
Correlation Between Changes to AGE Level and Changes to PSA
To assess whether changes in plasma AGE levels correlate with changes in PSA levels over the 85-day study period
Measured: 85 days
Correlation Between Changes to AGE Level and Changes to BMI
This outcome was intended to evaluate whether changes in plasma AGE levels from baseline to Day 85 correlated with changes in body mass index (BMI), planned for Screening, Day 1, and Day 85. Although this measure was protocol-specified, BMI assessments were never initiated because clinical research personnel responsible for baseline and follow-up measurements departed early in the study period, before any participants reached these scheduled assessment points. After this loss of personnel, the study team no longer had qualified staff to perform BMI measurements, and retrospective collection was not possible. As a result, no BMI data were collected for any participants.
Measured: 85 days
Correlation Between Changes to AGE Level and Changes to Insulin Resistance (HOMA-IR)
Measured: 85 days
Correlation Between Changes to AGE Level and Changes to A1C.
Measured: 85 days
Correlations Between Changes to AGE Level and Changes to Testosterone.
Measured: 85 days
Correlation Between Changes to AGE Level and Changes to Lipids.
Measured: 85 days
Correlation Between Changes to AGE Level and Changes to Diet
This outcome aimed to determine whether changes in plasma AGE levels correlated with changes in dietary intake, assessed using the NIH "Eating at America's Table Study Quick Food Scan" and the NCI "Quick Food Scan" at baseline and Day 85. Although protocol-specified, these instruments were never administered because essential study personnel who were responsible for conducting participant-reported assessments left the study before any questionnaire sessions occurred. After staff departure, the study team lacked the resources required to administer or score the diet questionnaires, and no alternative personnel were available. As a result, no dietary intake data were collected, and no analyses could be performed.
Measured: 85 days
Correlation Between Changes to AGE Level and Changes to Quality of Life
This outcome sought to evaluate whether changes in plasma AGE levels correlated with changes in quality of life, assessed with the FACT-P and AUA Symptom Index at baseline and Day 85. Although these assessments were included in the protocol, they were never initiated because the study personnel responsible for administering participant-reported questionnaires departed before any QOL data collection sessions were conducted. After the loss of staff, the study team did not have qualified personnel to administer, process, or score QOL instruments, making further collection infeasible. Consequently, no QOL data were collected for any participants.
Measured: 85 days
Frequency of Adverse Events as Assessed by CTCAE v. 4
To assess the frequency and severity of adverse events associated with study drug administration, categorized by CTCAE v4 criteria.
Measured: 85 days
Correlation Between AGE Levels and Plasma IL6
Measured: 85 days
Correlation Between AGE Levels and Leptin
Measured: 85 days
Correlation Between AGE Levels and C-reactive Protein (CRP)
Measured: 85 days
Correlation Between AGE Levels and Malondialdehyde (MDA)
Measured: 85 days
Correlation Between AGE Levels and oxLDLs (Low Density Lipoprotein)
Measured: 85 days
Correlation Between AGE Levels and sRAGE (Soluble Receptor for AGE)
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start28 Dec 2016
- Primary completion5 Dec 2023
- Study completion19 Aug 2024
Why it stopped: Investigator retired from clinical practice prior to enrollment goal being met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Lilly, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946996
- Sponsor's protocol ID
- 102508
- Status last verified
- Feb 2026
- First submitted
- 18 Oct 2016
- Last updated
- 5 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT02946996
- Acronym / sponsor ID
- 102508
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator retired from clinical practice prior to enrollment goal being met.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 28 Dec 2016 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at the effect that the study drug OPC has on AGE levels in patients with prostate cancer.
Detailed description
AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if Oligomeric Procyanidin Complex (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin Only | Experimental | Drug: MetforminSubjects will be supplied with metformin tablets850mg. During the ramp up phase subjects will take metformin in the morning. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart. |
| OPC Only | Experimental | Other: OPCSubjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12. |
| Metformin plus OPC | Experimental | Drug: Metformin, Other: OPCDuring week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about12 hours apart. During weeks 2-12 the metformin tablet will betaken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Subjects must be receiving ADT with a GnRH agonist or antagonist, with or without an anti-androgen, with a current testosterone level documented to be <50ng/dL at enrollment. Subjects whose ADT is interrupted may enroll or continue on study as long as the testosterone is documented to remain <50ng/dL for the entire duration of study participation. Subjects who have undergone orchiectomy are also eligible.
- Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed.
- Subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows:
- Able to swallow and retain oral medication
Key exclusion criteria (3 listed)
- Known allergy to grapes or grape seed
- History of receiving more than 2 classes of ADT.
- Current use of strong antioxidants (extracts from grape seed, milk thistle; pine bark, green tea, saw palmetto; resveratrol; flavonoids; catechins; ellagic acid), large quantities of red grapes, white button mushrooms, red wine. See section 4.7 for more details.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin | Drug | Metformin Only, Metformin plus OPC |
| OPCOPC is a derivative of grape seed extract | Other | Metformin plus OPC, OPC Only |
Primary outcome
AGE Level Reduction
Time frame: 85 days
The primary objective is to determine if any of the test agent are able to reduce AGE levels by an average of 30% (or greater) in 50% or more of test subjects.
15 secondary outcomes
Correlation Between Changes to AGE Level and Changes to PSA
Time frame: 85 days
Correlation Between Changes to AGE Level and Changes to BMI
Time frame: 85 days
Correlation Between Changes to AGE Level and Changes to Insulin Resistance (HOMA-IR)
Time frame: 85 days
Correlation Between Changes to AGE Level and Changes to A1C.
Time frame: 85 days
Correlations Between Changes to AGE Level and Changes to Testosterone.
Time frame: 85 days
Correlation Between Changes to AGE Level and Changes to Lipids.
Time frame: 85 days
Correlation Between Changes to AGE Level and Changes to Diet
Time frame: 85 days
Correlation Between Changes to AGE Level and Changes to Quality of Life
Time frame: 85 days
Frequency of Adverse Events as Assessed by CTCAE v. 4
Time frame: 85 days
Correlation Between AGE Levels and Plasma IL6
Time frame: 85 days
Correlation Between AGE Levels and Leptin
Time frame: 85 days
Correlation Between AGE Levels and C-reactive Protein (CRP)
Time frame: 85 days
Correlation Between AGE Levels and Malondialdehyde (MDA)
Time frame: 85 days
Correlation Between AGE Levels and oxLDLs (Low Density Lipoprotein)
Time frame: 85 days
Correlation Between AGE Levels and sRAGE (Soluble Receptor for AGE)
Time frame: 85 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lilly, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin and OPC in people with Prostate Cancer, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AGE Level Reduction (time frame: 85 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.