Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastat… (NCT03821792) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer
United States60 participantsStarted 2019-07-22
Plain-language summary
This phase II trial studies how well abiraterone acetate, prednisone, and apalutamide work in treating patients with hormone-naive prostate cancer that has spread to other places in the body. Androgen can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate and apalutamide may lessen the amount of androgen made by the body.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* At least 2 of the 3 following high-risk prognostic factors:
* Gleason score of \>= 8
* Presence of 3 or more lesions on bone scan
* Presence of measurable visceral (excluding lymph node disease) metastasis on computed tomography (CT) or magnetic resonance imaging (MRI) (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* Hemoglobin \>= 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to enrollment
* Platelet count \>= 100,000/uL independent of transfusion and/or growth factors within 3 months prior to enrollment
* Serum albumin \>= 3.0 g/dL
* Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Calculated creatinine clearance (Cockcroft-Gault equation) \>= 45 mL/min
* Serum potassium \>= 3.5 mEg/L
* Serum magnesium \>= 1.6 mg/dL
* Serum bilirubin \< 1.5 x institutional upper limit of normal (IULN) (except for patients with known Gilbert's disease if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 x ULN, subject may be eligible)
* Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 x IULN for patients without liver metastases. (Note: In subjects with Gilbert…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.