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New treatment option for Metastatic Cancer
Official title Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
ClinicalTrials.gov ID: NCT05422911
What this study is testing
What is Abiraterone acetate?
Abiraterone acetate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic cancer.
Also referred to as YONSA®, ZYTIGA®.
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 investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored.
- 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
- Veterans must meet the following to be eligible to participate:
- Be willing and able to provide written informed consent for the trial.
- Age ≥18 years of age on day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (on a scale from 0 to 5, with higher scores indicating greater disability...
- Histologically or cytologically confirmed adenocarcinoma of the prostate without morphologic evidence of small-cell features in either a recently...
You likely can't join if
- people with any of the following will not be enrolled:
- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide or darolutamide for the treatment of...
- Treatment with hormonal therapy (e.g., androgen receptor inhibitors other than bicalutamide, estrogens, 5-alpha reductase inhibitors) or biologic...
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).
- Patients who are receiving any other investigational agents concurrently.
- Clinically significant heart disease as evidenced by New York Heart Association (NYHA) Class III-IV heart disease.
See the full eligibility criteria
- Veterans must meet the following to be eligible to participate:
- Be willing and able to provide written informed consent for the trial.
- Age ≥18 years of age on day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).
- Histologically or cytologically confirmed adenocarcinoma of the prostate without morphologic evidence of small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.
- Have previously begun within 120 days of randomization or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or...
- Laboratory tests meet minimum safety requirements:
- Hepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN, Total bilirubin ≤1.5X upper limit of normal (ULN) [except for people with documented Gilbert's disease in which case total bilirubin not to exceed 10X...
- Renal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl
- Hematological: Platelet count ≥100,000/mm\^3; Hemoglobin \>9 g/dL; ANC \>1 X10\^9/L
- Serum potassium \>3 mEq/L
- people with any of the following will not be enrolled:
- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide or darolutamide for the treatment of prostate cancer or participation in a clinical trial of an...
- Treatment with hormonal therapy (e.g., androgen receptor inhibitors other than bicalutamide, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone-targeting agents...
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).
- Patients who are receiving any other investigational agents concurrently.
- Clinically significant heart disease as evidenced by New York Heart Association (NYHA) Class III-IV heart disease.
- Child-Pugh Class B and C
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Tampa, Florida, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- The Bronx, New York, United States
- Wappingers Falls, New York, United States
- Salisbury, North Carolina, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, 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; Tampa, Florida, United States; Ann Arbor, Michigan, United States; St Louis, Missouri, United States; New York, New York, United States; The Bronx, New York, United States and 6 more location(s). 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.