Status:
RECRUITING
A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy
Lead Sponsor:
University of Arkansas
Conditions:
Castration Sensitive Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
PHASE1
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, in...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06044025
Start Date
April 11 2024
End Date
October 1 2027
Last Update
February 6 2025
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205