Adenocarcinoma of the Prostate Clinical Trial
Official title:
An Open-Label, Phase I, Randomized Pharmacokinetic Study of Dietary Effects on Abiraterone Acetate Drug Levels in Patients With Metastatic Castration-Resistant Prostate Cancer (DEAL)
This randomized pilot phase I trial studies the side effects of dietary fat levels and abiraterone acetate uptake in patients with metastatic hormone-resistant prostate cancer. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Eating a low or high fat diet may increase the uptake of abiraterone acetate.
PRIMARY OBJECTIVES:
I. To assess the dietary effects of a low fat and high fat diet at a low abiraterone acetate
dose (250 mg) on drug levels compared to standard dose administered in a fasting condition.
SECONDARY OBJECTIVES:
I. To potentially guide decisions in the future to use low dose abiraterone in a fed state
and decrease overall cost.
II. To evaluate the potential relationship between esterase activity and abiraterone
metabolism in an exploratory analysis.
III. To determine the feasibility of using patient-collected dried blood spot (DBS) samples
for pharmacokinetic monitoring.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive standard dose abiraterone acetate orally (PO) once daily (QD) (held
on days 2, 3, 9, and 10), and low-dose abiraterone acetate PO QD on days 3 and 10. Patients
eat a low fat breakfast on day 3 and a high fat breakfast on day 10.
ARM II: Patients receive abiraterone acetate as in Arm I. Patients eat a high fat breakfast
on day 3, and a low fat breakfast on day 10.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02217709 -
Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer
|
Phase 2 | |
| Completed |
NCT03077659 -
Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03624660 -
Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer
|
N/A | |
| Completed |
NCT01054079 -
Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
|
Phase 2 | |
| Terminated |
NCT00512668 -
Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer
|
Phase 1 | |
| Completed |
NCT00087139 -
Ixabepilone in Treating Patients With Metastatic Prostate Cancer
|
Phase 2 | |
| Completed |
NCT00182052 -
Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT03511196 -
Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer
|
Early Phase 1 | |
| Active, not recruiting |
NCT01655836 -
High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
|
Phase 1 | |
| Terminated |
NCT03535675 -
Muscadine Plus (MPX) In Men With Prostate Cancer
|
Phase 3 | |
| Terminated |
NCT01866423 -
Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
|
Phase 2 | |
| Completed |
NCT02234921 -
Pilot Study of DRibble Vaccine for Prostate Cancer Patients
|
Phase 1 | |
| Completed |
NCT01468532 -
Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03686683 -
Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT03689699 -
Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04694924 -
Prospective Prostate Cancer and Patient-reported Outcomes Registry
|
||
| Active, not recruiting |
NCT04909294 -
Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma
|
N/A | |
| Completed |
NCT02225925 -
Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound
|
N/A | |
| Completed |
NCT01949519 -
Docetaxel and Lycopene in Metastatic Prostate Cancer
|
Phase 1 | |
| Completed |
NCT01433913 -
Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
|
Phase 2 |