Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive … (NCT03827473) | Clinical Trial Compass
TerminatedPhase 2
Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer
Stopped: The trial was closed because the changing standard of care landscape, making this trial not impactful anymore.
United States1 participantsStarted 2019-02-08
Plain-language summary
This phase II trial studies how well docetaxel or abiraterone acetate work when combined with androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and abiraterone acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Antihormone therapy, such as ADT may lessen the amount of androgen made by the body. It is not yet known whether docetaxel or abiraterone acetate work better when combined with ADT in treating patients with hormone sensitive prostate cancer.
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 diagnosed adenocarcinoma of the prostate.
* Radiographically confirmed metastatic disease prior to patient enrollment. Metastatic disease can be confirmed based on conventional imaging (CT, MRI, nuclear medicine bone scan) or molecular imaging (fluciclovine-positron emission tomography (PET)/CT, prostate-specific membrane antigen (PSMA)-PET/CT, Choline-PET/CT etc).
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2.
* Absolute neutrophil count (ANC) \>= 1.5 k/uL.
* Platelets \>= 100 k/uL.
* Hemoglobin \>= 9 g/dL.
* Serum total bilirubin =\< 1.5 times upper limit of normal (ULN) OR direct bilirubin =\< ULN for subjects with total bilirubin \>= 1.5 x ULN.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 x ULN OR =\< 4 x ULN for subjects with liver metastases.
* Creatinine \< 1.5 x ULN OR
* Creatinine clearance \> 50 mL/min for subject with creatinine levels \> 1.5 x ULN by Cockcroft-Gault formula or standard institutional practice.
* Highly effective method of contraception for both male and female partners of subjects throughout the study and for at least 3 months after last study treatment administration if the risk of conception exists.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
* Recovery to baseline or =\< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities r…
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
Change in Quality of Life - FACT-P
Timeframe: Planned for up to one year, but actual was 3 months