Antiandrogen Therapy, Abiraterone Acetate, and Prednisone With or Without Neutron Radiation Thera… (NCT03649841) | Clinical Trial Compass
TerminatedPhase 2
Antiandrogen Therapy, Abiraterone Acetate, and Prednisone With or Without Neutron Radiation Therapy in Treating Patients With Prostate Cancer
Stopped: Terminated due to low accrual.
United States10 participantsStarted 2020-06-29
Plain-language summary
This phase II trial studies how well antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy work in treating patients with prostate cancer. Hormone therapy such as antiandrogen therapy may fight prostate cancer by blocking the production and interfering with the action of hormones. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as prednisone, 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. Neutron radiation therapy uses high energy neutrons to kill tumor cells and shrink tumors. It is not yet known whether antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy may work better in treating patients with prostate cancer.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Pathologically proven (either histologic or cytologic) diagnosis of prostate adenocarcinoma with \< 50% neuroendocrine differentiation or small cell histology.
* At least one site of nodal or distant metastatic disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or a bony metastasis that is evaluable on both computed tomography (CT) and bone scan.
* No prior orchiectomy.
* No androgen deprivation therapy such as treatment with antiandrogens, luteinizing hormone-releasing hormone (LHRH) agonists or antagonists for at least one year prior to trial enrollment, and testosterone must be inside normal range prior to trial enrollment if there is prior history of ADT.
* No other systemic anti-cancer therapy for at least 1-year prior to enrollment.
* Prior prostate-directed therapies such as prostatectomy or cryotherapy are allowed.
* Prior radiation treatments are allowed (prostate or metastatic sites) but must have been completed at least 3 months prior to starting ADT for this trial.
* White blood cell (WBC) \> 3000/mm\^3.
* Absolute neutrophil count (ANC) \> 1000/mm\^3.
* Platelets \> 100,000/mm\^3.
* Creatinine \< 1.5 institutional upper limit of normal (ULN) or calculated creatinine clearance \> 30 ml/min.
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin \< 3 x institutional ULN (unless patient has documented Gilbert's syndrome).
* No steroids for at least 2 weeks prior to…
What they're measuring
1
Percent Change in Peripheral Blood Effector T-cells (CCR7-/CD45RO)
Timeframe: Baseline to 3 months after start of antiandrogen therapy (ADT)