Actively Recruiting
Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer
Led by Martha Mims · Updated on 2025-12-11
130
Participants Needed
3
Research Sites
984 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators are conducting this study with men that have prostate cancer and are getting standard of care treatment with the drugs abiraterone acetate and prednisone. The study will follow men with prostate cancer from initiation of participation in the study and for up to 10 years. The reason for the study is that researchers think that there may be a connection between the race and ethnicity of men with prostate cancer and how well the standard treatments work for the participants.
CONDITIONS
Official Title
Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 years or older
- Histologically or cytologically confirmed adenocarcinoma of the prostate with metastatic disease
- Radiographic assessment including bone or PET scan within 42 days prior to enrollment
- No more than 42 days of prior androgen deprivation therapy (medical or surgical) before starting abiraterone
- Willingness to continue LHRH agonist/antagonist and receive abiraterone plus prednisone
- Prior antiandrogen use allowed with willingness to switch to study drugs
- Prior neoadjuvant or adjuvant ADT allowed if less than 36 months total and completed at least 6 months prior with serum testosterone above 50 ng/dL
- High-risk or extensive metastatic hormone-sensitive prostate cancer per physician judgment eligible if unsuitable or declined docetaxel
- Recovery from major surgery for at least 14 days before enrollment
- Concurrent use of bone-targeting agents allowed if they do not affect PSA
- No plans to receive other experimental therapies during study
- Complete physical exam and medical history within 28 days prior to enrollment
- PSA level of 10 ng/mL or higher within 90 days prior to enrollment
- QTc interval below 461 msec on ECG within 42 days prior to enrollment
- Adequate liver function with bilirubin ≤2x upper limit normal and AST/ALT ≤3x upper limit normal (or ≤5x if liver metastases present)
- Adequate kidney function with creatinine clearance ≥40 mL/min
- Adequate blood counts including leukocytes ≥3000/mcL, neutrophils ≥1500/mcL, hemoglobin ≥9 g/dL, platelets ≥100,000/mcL
- Zubrod performance status of 0-2; status 3 allowed if due to bone pain only
- No other recent malignancy except certain treated skin cancers or cancers in remission for 5 years
- Informed consent obtained per guidelines
You will not qualify if you...
- Known brain metastases
- Prior or planned treatment with ketoconazole, aminoglutethimide, or enzalutamide
- Prior cytotoxic chemotherapy for metastatic prostate cancer; prior chemotherapy in neoadjuvant/adjuvant setting allowed if completed at least 2 years prior
- New York Heart Association Class III or IV heart failure
- Recent (within 6 months) thromboembolic event, unstable angina, myocardial infarction, or serious uncontrolled arrhythmia
- Known primary or secondary adrenal insufficiency
- Known hypersensitivity to abiraterone or LHRH agonist/antagonist
- Gastrointestinal disease or procedures interfering with abiraterone absorption or tolerance, including swallowing difficulties per investigator judgment
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Ben Taub General Hospital
Houston, Texas, United States, 77030
Actively Recruiting
2
Dan L. Duncan Comprehensive Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
3
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030
Active, Not Recruiting
Research Team
M
Martha Mims, MD, PhD
CONTACT
C
Carolyn Thibodeaux, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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