Back to resultsA Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy
Primary Purpose
Castration Sensitive Prostate Cancer
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Metformin
Turmeric
Sponsored by
About this trial
This is an interventional supportive care trial for Castration Sensitive Prostate Cancer
Eligibility Criteria
Inclusion Criteria: 18 years of age or older. History of prior prostatectomy and/or radiation therapy to the prostate. Currently have rising PSA levels ≥ 0.2 ng/ml if they have undergone radical prostatectomy, or a PSA ≥ nadir + 2 if they have received only radiotherapy. Patients who were not offered salvage radiotherapy as an alternative treatment will be considered ineligible (due to a high PSA, other medical concerns). Currently have at least 2 consecutively rising serum PSA levels more than 1 week apart Currently have a PSA doubling time < 9 months obtained within 60 days of consent. Eugonad with testosterone > 150 ng/dl at time of consent. Prior ADT (including iADT) for up to 24 months in association with definitive treatment is permitted if completed at least 12 months prior to consent. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1. Willing to take study agents at the dose specified with meals. Willing to discontinue current vitamin/mineral supplements and use only those provided by study. Herbal supplements may still be used. Exclusion Criteria: Current Chronic Lymphocytic Leukemia (CLL), Monoclonal Gammopathy of Unknown Significance (MGUS), Renal Cell Carcinoma (RCC) or another cancer requiring active treatment. Indolent or stable malignancies such as non-melanoma skin cancers are allowed. Any active or deteriorating liver or renal disease, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C or bone marrow deficiency. Any history of allergic reactions attributed to turmeric, metformin, or other compounds of similar chemical or biologic compositions. History of lactic acidosis or risk factors for lactic acidosis (e.g., renal impairment, concomitant use of carbonic anhydrase inhibitors such as topiramate, hypoxic states such as acute congestive heart failure, excessive alcohol intake, and hepatic impairment). Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metformin + Turmeric
Arm Description
Each subject will begin using metformin and turmeric within 7 days of consent. Subjects will start with metformin 500 mg by mouth (po) two times daily (bid) with meals for 14 days. Metformin titration will then increase to 850 milligram (mg) po bid for 14 days before increasing titration to a desired dosage of 1,000 mg po bid. For those subjects currently taking Metformin, they will continue current dose (if 1,000 mg po bid) or titrate dose as just described until maximum dose is achieved. Each subject will start with 1,500 mg turmeric po daily with meals and reduce to 750 mg po daily or every other day for those who experience gastrointestinal (GI) discomfort. Once GI discomfort has resolved, subjects will resume 1,500 mg po daily unless otherwise specified by study doctor.
Outcomes
Primary Outcome Measures
Assess feasibility of recruitment
Assessed using frequency (in percentage) of the number of subjects enrolled in the first six and twelve months out of the total desired accrual
Evaluate time to PSA relapse with nutritional intervention on iADT.
Observed from the time of consent to the time of PSA relapse or at the end of the study period (i.e., 27 months), whichever comes first. A survival curve will be used to estimate the accumulated rate of PSA relapse over time (over 27 months).
Secondary Outcome Measures
Quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P), Version 4.
Obtain Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores at baseline, after completion of 8 months of iADT with nutritional intervention, and at the end of the study (i.e., after 27 months). Minimum and maximum values 0-156. Higher scores indicate better outcome.
Quality of Life (QOL) assessed by the Aging Male Symptoms Questionnaire (AMS Questionnaire).
Obtain Aging Male Symptoms Questionnaire (AMS Questionnaire) scores at baseline, after completion of 8 months of iADT with nutritional intervention, and at the end of the study (i.e., after 27 months). Minimum and maximum values 17-85. Higher scores indicate worse outcome.
Full Information
NCT ID
NCT06044025
First Posted
August 29, 2023
Last Updated
October 3, 2023
Sponsor
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT06044025
Brief Title
A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy
Official Title
A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical trial is to assess the feasibility of adding a combination of metformin and turmeric as part of a nutritional intervention regimen to the current standard of care, namely, intermittent Androgen Deprivation Therapy (iADT), for patients with castration sensitive biochemical progressive prostate cancer.
The main objectives are:
Assess the feasibility of the study population and enrollment.
Evaluate time to PSA relapse with nutritional intervention on iADT.
Participants who are receiving iADT will be dispensed Metformin and turmeric and complete a pill diary. Participants will also have blood and stool samples collected and complete quality of life questionnaires.
The long-term goal is to further assess the efficacy and safety of this nutritional regimen and the roles of metabolic syndrome, microenvironment/microbiome, and genomic vs epigenomic profiles in the care of these patients through a clinical trial.
Detailed Description
The purpose of this research is to determine if a nutritional plan of metformin and turmeric is feasible for individuals receiving iADT for prostate cancer. Turmeric is an over-the-counter supplement that is believed to provide anti-inflammatory effects. Metformin is an FDA-approved medication for diabetes to help lower blood sugar. This feasibility study will be conducted according to the standard of care (SoC) for eligible subjects receiving iADT but coordinated and streamlined in a prospective manner to care for subjects while collecting and annotating data for the duration of their care.
All subjects will receive iADT + turmeric + metformin + dietary consultation.
SoC laboratory tests will be performed in accordance with clinical practice for the care of patients with prostate cancer on or off iADT. Additional vials of blood will be collected for research purposes in order to assess epigenetic biomarkers, CSC biomarkers, and cancer dormancy biomarkers. Stool samples will be used to obtain microbiome profiles. QOL instruments (FACT-P and AMS) will also be administered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration Sensitive Prostate Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metformin + Turmeric
Arm Type
Experimental
Arm Description
Each subject will begin using metformin and turmeric within 7 days of consent. Subjects will start with metformin 500 mg by mouth (po) two times daily (bid) with meals for 14 days. Metformin titration will then increase to 850 milligram (mg) po bid for 14 days before increasing titration to a desired dosage of 1,000 mg po bid. For those subjects currently taking Metformin, they will continue current dose (if 1,000 mg po bid) or titrate dose as just described until maximum dose is achieved.
Each subject will start with 1,500 mg turmeric po daily with meals and reduce to 750 mg po daily or every other day for those who experience gastrointestinal (GI) discomfort. Once GI discomfort has resolved, subjects will resume 1,500 mg po daily unless otherwise specified by study doctor.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Subjects will start with metformin 500 mg by mouth (po) two times daily (bid) with meals for 14 days. Metformin titration will then increase to 850 milligram (mg) po bid for 14 days before increasing titration to a desired dosage of 1,000 mg po bid. For those subjects currently taking Metformin, they will continue current dose (if 1,000 mg po bid) or titrate dose as just described until maximum dose is achieved.
Intervention Type
Drug
Intervention Name(s)
Turmeric
Intervention Description
Each subject will start with 1,500 mg turmeric po daily with meals and reduce to 750 mg po daily or every other day for those who experience gastrointestinal (GI) discomfort. Once GI discomfort has resolved, subjects will resume 1,500 mg po daily unless otherwise specified by study doctor.
Primary Outcome Measure Information:
Title
Assess feasibility of recruitment
Description
Assessed using frequency (in percentage) of the number of subjects enrolled in the first six and twelve months out of the total desired accrual
Time Frame
12 months of enrollment being open
Title
Evaluate time to PSA relapse with nutritional intervention on iADT.
Description
Observed from the time of consent to the time of PSA relapse or at the end of the study period (i.e., 27 months), whichever comes first. A survival curve will be used to estimate the accumulated rate of PSA relapse over time (over 27 months).
Time Frame
up to 27 months
Secondary Outcome Measure Information:
Title
Quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P), Version 4.
Description
Obtain Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores at baseline, after completion of 8 months of iADT with nutritional intervention, and at the end of the study (i.e., after 27 months). Minimum and maximum values 0-156. Higher scores indicate better outcome.
Time Frame
up to 27 months
Title
Quality of Life (QOL) assessed by the Aging Male Symptoms Questionnaire (AMS Questionnaire).
Description
Obtain Aging Male Symptoms Questionnaire (AMS Questionnaire) scores at baseline, after completion of 8 months of iADT with nutritional intervention, and at the end of the study (i.e., after 27 months). Minimum and maximum values 17-85. Higher scores indicate worse outcome.
Time Frame
up to 27 months
Other Pre-specified Outcome Measures:
Title
Expression levels of Metabolomic biomarkers from blood samples
Description
Assessed at baseline, after 8 months of iADT with nutritional intervention, and at 27 months, and will be summarized using mean ± standard deviation and/or median (min, max)
Time Frame
up to 27 months
Title
Expression levels of CSC biomarkers including EMT and miRNAS from blood samples
Description
Assessed at baseline, after 8 months of iADT with nutritional intervention, and at 27 months, and will be summarized using mean ± standard deviation and/or median (min, max)
Time Frame
up to 27 months
Title
Expression levels of Cancer dormancy Biomarkers (miR-200s, TGF-beta, BMPs, immune and inflammatory factors) from blood samples
Description
Assessed at baseline, after 8 months of iADT with nutritional intervention, and at 27 months, and will be summarized using mean ± standard deviation and/or median (min, max)
Time Frame
up to 27 months
Title
Microbiome profiling from the stool samples to assess gut microbiome
Description
Assessed at baseline, after 8 months of iADT with nutritional intervention, and at 27 months, and will be summarized using mean ± standard deviation and/or median (min, max)
Time Frame
up to 27 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older.
History of prior prostatectomy and/or radiation therapy to the prostate.
Currently have rising PSA levels ≥ 0.2 ng/ml if they have undergone radical prostatectomy, or a PSA ≥ nadir + 2 if they have received only radiotherapy. Patients who were not offered salvage radiotherapy as an alternative treatment will be considered ineligible (due to a high PSA, other medical concerns).
Currently have at least 2 consecutively rising serum PSA levels more than 1 week apart
Currently have a PSA doubling time < 9 months obtained within 60 days of consent.
Eugonad with testosterone > 150 ng/dl at time of consent.
Prior ADT (including iADT) for up to 24 months in association with definitive treatment is permitted if completed at least 12 months prior to consent.
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
Willing to take study agents at the dose specified with meals.
Willing to discontinue current vitamin/mineral supplements and use only those provided by study. Herbal supplements may still be used.
Exclusion Criteria:
Current Chronic Lymphocytic Leukemia (CLL), Monoclonal Gammopathy of Unknown Significance (MGUS), Renal Cell Carcinoma (RCC) or another cancer requiring active treatment. Indolent or stable malignancies such as non-melanoma skin cancers are allowed.
Any active or deteriorating liver or renal disease, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C or bone marrow deficiency.
Any history of allergic reactions attributed to turmeric, metformin, or other compounds of similar chemical or biologic compositions.
History of lactic acidosis or risk factors for lactic acidosis (e.g., renal impairment, concomitant use of carbonic anhydrase inhibitors such as topiramate, hypoxic states such as acute congestive heart failure, excessive alcohol intake, and hepatic impairment).
Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Holley
Phone
5016868274
Email
jaholley@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Scanlan
Phone
5016868274
Email
bscanlan@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi-Ming Tu, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Holley
Phone
501-686-8274
Email
jaholley@uams.edu
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy
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