Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With… (NCT02913196) | Clinical Trial Compass
CompletedPhase 1
Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC
United States16 participantsStarted 2016-12-30
Plain-language summary
This is a multi-center, Phase I study of apalutamide in combination with abiraterone acetate, docetaxel and prednisone in patients with metastatic mastrate resistant prostate cancer (mCRPC).
This study is designed to determine the dose that apalutamide can be administered safely in combination with abiraterone acetate, docetaxel and prednisone.
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 prostate
. Documented progressive metastatic CRPC based on at least one of the following criteria:
. PSA progression according to Prostate Cancer Working Group 3 (PCWG3) criteria
. Objective radiographic progression in soft tissue, according to modified Response Evaluation Criteria In Solid Tumors (RECIST) or bone scans
. ECOG performance status of 0-2
. Have serum testosterone \< 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy
. Age \>18 years
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.
What they're measuring
1
Number of participants with dose limiting toxicities (DLT)
Timeframe: From the time of study drug administration till PSA progression or study completion (~36 months)
Trial details
NCT IDNCT02913196
SponsorWeill Medical College of Cornell University
. Patients must have normal organ and marrow function as defined below:
Exclusion criteria
. Liver Function
. If total bilirubin is \>1.5 x ULN (NOTE: in subjects with Gilbert's syndrome, if total bilirubin is \>1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
. Alanine (ALT) or aspartate (AST) aminotransferase \>1.5xULN (or \>5xULN for subject with liver metastasis) concomitant with alkaline phosphatase \>2.5xULN (or \>5xULN for subjects with bone or liver metastases) or
. Alanine (ALT or aspartate (AST) aminotransferase \>2.5xULN (or \>5xULN for subjects with liver metastasis
. Use of investigational drugs (including vaccines) or implantation of invasive medical device ≤4 weeks or \<5 half-lives of Cycle 1, Day 1 or current enrollment in investigational drug or device study
. Prior exposure to apalutamide. Prior exposure to abiraterone acetate and/or other CYP17 inhibitors, enzalutamide is allowed (but not preferred) only during the dose escalation period
. Prior chemotherapy for advanced prostate cancer. Prior chemotherapy for any other disease within 3 years