Prostate CancerPhase 1NCT03465345
Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
A Phase 1 study testing Metformin and Oligomeric Procyanidin Complex in people with Prostate Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The overall goal of this study is to identify a safe dose of metformin, in combination with oligomeric procyanidin complex (OPC) for pharmacologic reduction of 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 Oligomeric Procyanidin Complex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2018to 11 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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.
- 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 Cockkroft and Gault formula (see appendix C).
- Liver Function: Total bilirubin ≤ULN, AST and ALT <1.5xULN, Prior radiation therapy allowed
Show all 12Show fewer
- Subjects may have diabetes mellitus but must not be taking metformin.
- Able to swallow and retain oral medication
- ECOG performance status of 0 - 2
- Ability to sign written informed consent
- Testosterone level <50ng/dL at time of enrollment.
- Age 18 or older.
Who cannot join
- Known allergy to grapes or grape seed
- Known hypersensitivity or intolerance to metformin.
- Any condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as NYHA Class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day).
- Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed.
- History of receiving more than 2 classes of ADT.
- Current use of metformin, or 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
- PSA doubling time of <6 months, measured over the 3 months prior to enrollment.
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: Phase 1b Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
The overall goal of this study is to identify a safe dose of metformin, in combination with oligomeric procyanidin complex (OPC) for pharmacologic reduction of AGE levels in patients with prostate cancer.
Read the detailed description
AGEs (advanced glycation endpoints) 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 identify safe pharmaceutical agents that can reduce the AGE levels in subjects with advanced cancer.
- Conditions
- Prostate Cancer
- Being tested
- Metformin, Oligomeric Procyanidin Complex
- 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
Metformin: The starting dose for Metformin is 850mg once a day, the second dose is 850mg once a day; the third dose level is 850mg twice a day; the fourth dose level is 850mg twice a day. Each dose level lasts for 28 days.
Oligomeric Procyanidin ComplexDrug
Also called OPC
OPC: The starting dose for OPC is 500mg once a day; the second dose is 1000mg once a day; the third dose level is 1000mg once a day; the fourth dose level is 1500mg once a day. Each dose level lasts for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Metformin + OPC dose escalation | Experimental | Not described Receives: Drug: Metformin; Drug: Oligomeric Procyanidin Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of metformin in combination with OPC in PCa subjects.
Measured: 112 days
Secondary outcomes (11)
Correlation between changes to AGE level and changes to PSA.
Measured: 112 days
Correlation between changes to AGE level and changes to BMI.
Measured: 112 days
Correlation between changes to AGE level and changes to insulin resistance.
Measured: 112 days
Correlation between changes to AGE level and changes to A1C.
Measured: 112 days
Correlations between changes to AGE level and changes to testosterone.
Measured: 112 days
Correlation between changes to AGE level and changes to diet.
Measured: 112 days
Correlation between changes to AGE level and changes to quality of life.
FACT-P and AUA questionnaires
Measured: 112 days
Frequency of adverse events as assessed by CTCAE v. 4
Toxicities will be tabulated by type and grade and the proportion of patients with grade 3, grade 4 or an SAE will be estimated with a 90% confidence interval.
Measured: 112 days
Correlation between AGE levels and sRAGE (soluble receptor for AGE) expression and signaling.
Measured: 112 days
Correlation between changes to AGE level and OPC metabolite levels.
Measured: 112 days
Correlation between changes to AGE level and changes in the stool. microbiome.
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start11 Jul 2018
- Primary completion11 Jul 2018
- Study completion11 Jul 2018
Why it stopped: Study was stopped to pursue a new treatment plan with a new study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT03465345
- Sponsor's protocol ID
- 102797
- Status last verified
- Aug 2018
- First submitted
- 27 Feb 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- 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 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT03465345
- Acronym / sponsor ID
- 102797
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was stopped to pursue a new treatment plan with a new study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to identify a safe dose of metformin, in combination with oligomeric procyanidin complex (OPC) for pharmacologic reduction of AGE levels in patients with prostate cancer.
Detailed description
AGEs (advanced glycation endpoints) 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 identify safe pharmaceutical agents that can reduce the AGE levels in subjects with advanced cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin + OPC dose escalation | Experimental | Drug: Metformin, Drug: Oligomeric Procyanidin Complex |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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.
- Subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows:
- Subjects may have diabetes mellitus but must not be taking metformin.
- Able to swallow and retain oral medication
Key exclusion criteria (7 listed)
- Known allergy to grapes or grape seed
- Known hypersensitivity or intolerance to metformin.
- Any condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as NYHA Class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day).
- Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed.
- History of receiving more than 2 classes of ADT.
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 |
|---|---|---|
| MetforminMetformin: The starting dose for Metformin is 850mg once a day, the second dose is 850mg once a day; the third dose level is 850mg twice a day; the fourth dose level is 850mg twice a day. Each dose level lasts for 28 days. | Drug | Metformin + OPC dose escalation |
| Oligomeric Procyanidin ComplexAlso: OPCOPC: The starting dose for OPC is 500mg once a day; the second dose is 1000mg once a day; the third dose level is 1000mg once a day; the fourth dose level is 1500mg once a day. Each dose level lasts for 28 days. | Drug | Metformin + OPC dose escalation |
Primary outcome
Maximum tolerated dose (MTD) of metformin in combination with OPC in PCa subjects.
Time frame: 112 days
11 secondary outcomes
Correlation between changes to AGE level and changes to PSA.
Time frame: 112 days
Correlation between changes to AGE level and changes to BMI.
Time frame: 112 days
Correlation between changes to AGE level and changes to insulin resistance.
Time frame: 112 days
Correlation between changes to AGE level and changes to A1C.
Time frame: 112 days
Correlations between changes to AGE level and changes to testosterone.
Time frame: 112 days
Correlation between changes to AGE level and changes to diet.
Time frame: 112 days
Correlation between changes to AGE level and changes to quality of life.
Time frame: 112 days
Frequency of adverse events as assessed by CTCAE v. 4
Time frame: 112 days
Correlation between AGE levels and sRAGE (soluble receptor for AGE) expression and signaling.
Time frame: 112 days
Correlation between changes to AGE level and OPC metabolite levels.
Time frame: 112 days
Correlation between changes to AGE level and changes in the stool. microbiome.
Time frame: 112 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- 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 1 study testing Metformin and Oligomeric Procyanidin Complex 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 12 inclusion and 7 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: withdrawn, as of the sponsor's last update on 3 Aug 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Maximum tolerated dose (MTD) of metformin in combination with OPC in PCa subjects. (time frame: 112 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 3 Aug 2018.