Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prosta… (NCT03565835) | Clinical Trial Compass
CompletedPhase 2
Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer
United States31 participantsStarted 2018-06-13
Plain-language summary
The goal of this study is to find out if patients with prostate cancer being treated with the medications abiraterone and prednisone can discontinue hormone injections (examples include leuprolide, goserelin, triptorelin and degarelix). Abiraterone and prednisone are pills used to treat patients with prostate cancer. When abiraterone and prednisone are used, hormone injections are usually continued to maintain a low testosterone level in the blood. This study is being done to find out if testosterone in the blood will stay low while abiraterone and prednisone are used without continued hormone injections.
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:
* The patient must be able to provide study-specific informed consent prior to study entry
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Pathologically proven diagnosis of prostate adenocarcinoma
* Patients must have metastatic prostate cancer
* Patients may have mCRPC or may have metastatic castration-sensitive disease.
* Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, histrelin, deslorelin) or antagonist (degarelix))
* The patient and the investigator have decided that the next line of cancer therapy will be abiraterone plus prednisone and the initial dose of abiraterone will be 1000 mg daily. Or patients may already be on abiraterone with prednisone at a dose of 1000 mg daily along with a GnRH analogue.
* Lab values meeting the following criteria
* Total testosterone level of \<50 ng/dl
* Total bilirubin \< 2.0 X Upper Limit of Normal (ULN)
* Aspartate aminotransferase (AST) ≤ 3 X ULN
* Alanine aminotransferase (ALT) ≤ 3 X ULN
* Absolute Neutrophil Count \> 1.5 K/mm3
* Platelets \> 100 K/mm3
* Hemoglobin ≥ 9.0 g/dL
* Calculated creatinine clearance ≥ 30 mL/min
Exclusion Criteria:
* History of bilateral orchiectomy
* History of hypopituitarism
* For patients not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic blood pressure \>170 mm Hg or diastolic blood pressure \>100 mm Hg)
* Patients must not have New York Heart Association Class III or IV…
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
Percentage of Patients With Castrate Level of Serum Testosterone