A Phase 1/2 interventional study of green tea and quercetin + docetaxel and Placebo + docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC), sponsored by Charles Drew University of Medicine and Science. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Charles Drew University of Medicine and Science · Phase 1/2, Interventional, and Treatment
Among 3,595 studies in Prostatic Neoplasms with a site in United States — 612 open to participants now, 980 under way, 101 of them phase 3. Prostatic Neoplasms · United States.
Among the 3,595 studies in Prostatic Neoplasms with a site in United States, this one is the 959th largest by planned enrollment of the 3,023 interventional ones, is one of 176 that started in 2026, is one of 283 in phase 1/2, reaches primary completion later than 655 of the 971 other live ones, and was the 3,261st registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 99 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →612 of the 3,595 studies in Prostatic Neoplasms with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →3,595 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 176 started in 2026.
Median enrollment 48 across the 3,023 interventional studies, 157 across the 477 observational. Of the 2,355 that completed or were terminated, 997 (42%) have results posted.
921 of 3,595 have an industry lead sponsor. The 10 most frequent:
Charles Drew University of Medicine and Science is the lead sponsor of 43 studies on the registry; 1 is open to participants now.
Charles Drew University of Medicine and Science has 1 study filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
341 of the studies in Prostatic Neoplasms with a site in United States that are under way reach primary completion within a year, 26 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04134260Phase 3NRG OncologyTesting the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial | 2026-11-01 |
| NCT03348670Phase 3Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairPharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms | 2026-11-18 |
| NCT03767244Phase 3Janssen Research & Development, LLCA Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy | 2026-12-01 |
| NCT06970847Phase 3Clarity Pharmaceuticals Ltd64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer | 2026-12-31 |
| NCT02446405Phase 3University of SydneyEnzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer | 2026-12-31 |
Among the 3,595 studies in Prostatic Neoplasms with a site in United States, from their registry updates:
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.
Researchers will compare green tea plus quercetin to a placebo (a look-alike substance that contains no drug) in combination with docetaxel to see if green tea and quercetin works to improve the therapeutic effect of docetaxel.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Green tea and quercetin capsules will be administered in combination with docetaxel treatment.
Drug: green tea and quercetin + docetaxel
Placebo capsules will be administered in combination with docetaxel treatment as comparison.
Drug: Placebo + docetaxel
Efficacy evaluated with blood prostate specific antigen (PSA) level
Blood PSA will be measured at baseline, 1st day of each cycle of docetaxel treatment (21 days per cycle, for 3 cycles), and at the end of the intervention.
Time frame: From enrollment to the end of treatment at 11 weeks
circulating tumor DNA level (ctDNA) analyzed by next generation sequencing
CtDNA will be measured at the 1st day of each cycle of docetaxel treatment, and at the end of the intervention.
Time frame: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
tumor burden by CT detection
Tumor burden, including tumor number and size, will be assessed in both primary and metastatic sites using computed tomography (CT), to assist in the evaluation of complete response vs. stable disease vs. progressive disease using the RECIST criteria.
Time frame: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
Adverse events graded by using NCI CTCAE criteria
The Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, will be followed for a comprehensive evaluation of adverse events in multiple systems including blood, liver, gastrointestinal tract, and neural system.
Time frame: From the start of intervention at 3 weeks to the end of treatment at 11 weeks.
Area under curve (AUC) of blood green tea, quercetin, and docetaxel
The AUC of blood green tea, quercetin, and docetaxel will be analyzed in cycle 1 of different dose levels in the dose escalation study.
Time frame: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
Maximum concentrations (Cmax) of blood green tea, quercetin, and docetaxel
The Cmax of blood green tea, quercetin, and docetaxel will be analyzed in cycle 1 of different dose levels in the dose escalation study.
Time frame: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
Time taken to reach the maximum concentration (Tmax)
The Tmax of blood green tea, quercetin, and docetaxel will be analyzed in cycle 1 of different dose levels in the dose escalation study.
Time frame: On the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2028, 18 months later.
Of 114 non-industry phase 1/2 interventional studies under Prostatic Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 85. This study's planned 18 months is below that.
Counting every sponsor, half of 210 studies reached it within 61 months; a quarter within 30 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Tea · Quercetin · Docetaxel
Charles Drew University of Medicine and Science