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New treatment option for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Official title Green Tea and Quercetin in Combination With Docetaxel Chemotherapy in Castration-resistant Prostate Cancer Patients
ClinicalTrials.gov ID: NCT06615752
What this study is testing
What is green tea and quercetin + docetaxel?
green tea and quercetin + docetaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic castration-resistant prostate cancer (mcrpc).
Also referred to as GT and Q.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to find out if taking natural products green tea and quercetin along with docetaxel chemotherapy improves the therapy of advanced prostate cancer, i.e., metastatic castration-resistant prostate cancer (mCRPC). It will also learn about the safety of this combination.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Signed and dated informed consent form and HIPPA (Health Insurance Portability and Accountability Act) authorization.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male patients 18 years or older
- Diagnosed with metastatic prostate cancer
- History of confirmed progressive disease with concurrent use of medical castration (e.g. luteinizing hormone-releasing hormone analogue), or surgical...
You likely can't join if
- Prior treatment of chemotherapy and/or radiotherapy for metastatic disease
- Any comorbid condition that would preclude the administration of docetaxel/prednisone
- Ongoing alcohol abuse
- Significant medical or psychiatric conditions that would make the patient a poor protocol candidate
- Prior allergic reaction to tea, tea products or quercetin supplements
- Allergies to multiple food items or nutritional supplements
See the full eligibility criteria
- Signed and dated informed consent form and HIPPA (Health Insurance Portability and Accountability Act) authorization.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male patients 18 years or older
- Diagnosed with metastatic prostate cancer
- History of confirmed progressive disease with concurrent use of medical castration (e.g. luteinizing hormone-releasing hormone analogue), or surgical castration
- Confirmed progressive disease with concurrent use of enzalutamide, apalutamide, darolutamide, and/or abiraterone acetate
- Clinical decision to start doc infusion with prednisone treatment
- Adequate bone marrow function (absolute neutrophil count (ANC) more than1500 cells/mm³, platelet count more than 100,000 cells/mm³)
- Adequate liver function (total bilirubin less than upper limit of normal (ULN), alanine aminotransferase (ALT) less than 1.5 x ULN, aspartate aminotransferase (AST) less than 1.5 x ULN)
- Adequate renal function (serum creatinine level within normal limits)
- At least a 6-month or greater life expectancy
- Willing to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention
- Prior treatment of chemotherapy and/or radiotherapy for metastatic disease
- Any comorbid condition that would preclude the administration of docetaxel/prednisone
- Ongoing alcohol abuse
- Significant medical or psychiatric conditions that would make the patient a poor protocol candidate
- Prior allergic reaction to tea, tea products or quercetin supplements
- Allergies to multiple food items or nutritional supplements
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.