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Investigator retired from clinical practice prior to enrollment goal being met.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug |
| ||
| OPC |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 85 days |
| Correlation Between Changes to AGE Level and Changes to BMI |
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Inclusion Criteria
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
ECOG performance status of 0 - 2
Ability to sign written informed consent
Testosterone level <50ng/dL
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lilly, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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Overall 14 non-evaluable
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin Only | 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. Metformin |
| FG001 | OPC Only |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2023 |
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OPC is a derivative of grape seed extract |
|
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.
| 85 days |
| Correlation Between Changes to AGE Level and Changes to Insulin Resistance (HOMA-IR) | 85 days |
| Correlation Between Changes to AGE Level and Changes to A1C. | 85 days |
| Correlations Between Changes to AGE Level and Changes to Testosterone. | 85 days |
| Correlation Between Changes to AGE Level and Changes to Lipids. | 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. | 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. | 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. | 85 days |
| Correlation Between AGE Levels and Plasma IL6 | 85 days |
| Correlation Between AGE Levels and Leptin | 85 days |
| Correlation Between AGE Levels and C-reactive Protein (CRP) | 85 days |
| Correlation Between AGE Levels and Malondialdehyde (MDA) | 85 days |
| Correlation Between AGE Levels and oxLDLs (Low Density Lipoprotein) | 85 days |
| Correlation Between AGE Levels and sRAGE (Soluble Receptor for AGE) | 85 days |
Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12. OPC: OPC is a derivative of grape seed extract |
| FG002 | Metformin Plus OPC | 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. Metformin OPC: OPC is a derivative of grape seed extract |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin Only | 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. Metformin |
| BG001 | OPC Only | Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12. OPC: OPC is a derivative of grape seed extract |
| BG002 | Metformin Plus OPC | 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. Metformin OPC: OPC is a derivative of grape seed extract |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | 30% Confidence Interval | ng/ml | 85 days |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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 | Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned. | Posted | 85 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | No BMI assessments were conducted, and zero participants contributed analyzable data. | Posted | 85 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Changes to AGE Level and Changes to Insulin Resistance (HOMA-IR) | Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned. | Posted | 85 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Changes to AGE Level and Changes to A1C. | Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned. | Posted | 85 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Correlations Between Changes to AGE Level and Changes to Testosterone. | Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned. | Posted | 85 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Changes to AGE Level and Changes to Lipids. | Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned. | Posted | 85 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Dietary questionnaires were never administered; zero participants contributed analyzable data. | Posted | 85 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | No quality-of-life assessments were conducted; zero participants contributed analyzable data. | Posted | 85 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned. | Posted | Count of Participants | Participants | 85 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between AGE Levels and Plasma IL6 | Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned. | Posted | 85 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between AGE Levels and Leptin | Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned. | Posted | 85 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between AGE Levels and C-reactive Protein (CRP) | Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned. | Posted | 85 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between AGE Levels and Malondialdehyde (MDA) | Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned. | Posted | 85 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between AGE Levels and oxLDLs (Low Density Lipoprotein) | Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned. | Posted | 85 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between AGE Levels and sRAGE (Soluble Receptor for AGE) | Samples were collected, but after the grant expired and all personnel were lost, the status and integrity of the stored samples could no longer be confirmed. Because the unprocessed raw samples could not be verified or validated, they were not analyzable. No further data processing is planned. | Posted | 85 days |
|
85 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin Only | 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. Metformin | 0 | 12 | 0 | 12 | 9 | 12 |
| EG001 | OPC Only | Subjects will take one OPC capsule at the same time each morning and evening, approximately 12 hours apart during weeks 1-12. OPC: OPC is a derivative of grape seed extract | 0 | 16 | 0 | 16 | 4 | 16 |
| EG002 | Metformin Plus OPC | 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. Metformin OPC: OPC is a derivative of grape seed extract | 0 | 13 | 0 | 13 | 9 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | nausea, diarrhea, bloating |
| |
| Dizziness | Nervous system disorders | Non-systematic Assessment | Headache |
| |
| broken tooth | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| weight loss | Investigations | Non-systematic Assessment |
| ||
| flank pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| fatigue | General disorders | Non-systematic Assessment |
| ||
| Libido Decreased | Psychiatric disorders | Non-systematic Assessment |
| ||
| Hot Flashes | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Pruritis, hyperhydrosis |
| |
| nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Upper respiratory infection |
| |
| knee swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| R ankle pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dry Eye | Eye disorders | Non-systematic Assessment |
| ||
| Hypertension | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hip Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| nocturia | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hematuria | Blood and lymphatic system disorders | Non-systematic Assessment |
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| leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | gout |
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| non cardiac chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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The study ended early following grant expiration and loss of essential personnel, preventing verification and analysis of collected biospecimens. Several protocol-specified clinical assessments (BMI, diet, quality of life) were not collected due to operational constraints. These limitations significantly restrict interpretation of secondary endpoints and planned correlative analyses.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tricia Bentz CTO Administrative Director | Medical University of South Carolina | 8437921415 | adraleta@musc.edu |
| Jan 3, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Male |
|
| White |
|
|
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. Metformin OPC: OPC is a derivative of grape seed extract |
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| Metformin Plus OPC |
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. Metformin OPC: OPC is a derivative of grape seed extract |
|
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. Metformin OPC: OPC is a derivative of grape seed extract |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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