Study on Enzalutamide and Cabazitaxel for Treating Metastatic, Hormone-Resistant Prostate Cancer
Sponsor: OHSU Knight Cancer Institute
ClinicalTrials ID:NCT02522715
This clinical trial is testing a combination of two drugs, enzalutamide and cabazitaxel, to see if they can effectively treat prostate cancer that has spread and is no longer responding to hormone therapy.
Patient Parameters
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Program Overview
The purpose of this study is to find out if combining enzalutamide, a hormone therapy, with cabazitaxel, a chemotherapy drug, can better treat prostate cancer that has spread to other parts of the body and is resistant to hormone treatments. Enzalutamide works by blocking the effects of androgens, which can promote the growth of prostate cancer cells. Cabazitaxel helps stop cancer cells from growing and spreading. The study aims to determine the best dose of cabazitaxel when used with enzalutamide and to evaluate the safety and effectiveness of this combination.
Description
The main goals of this study are to determine how safe and tolerable the combination of enzalutamide and cabazitaxel is for patients with metastatic, hormone-resistant prostate cancer, and to see how effective it is in reducing prostate-specific antigen (PSA) levels, which are indicators of prostate cancer activity. Researchers will also collect data on any side effects and measure how well the cancer responds to the treatment.
Participants will receive cabazitaxel through an IV on the first day of each cycle and take enzalutamide pills daily. They will also take prednisone as part of the standard care. Treatment cycles repeat every 21 days for up to 10 cycles, as long as the cancer does not progress and side effects are manageable. After completing the treatment, participants will have follow-up visits to monitor their health and the long-term effects of the treatment.
The study will also explore potential biological markers that might predict how well patients respond to the treatment, by analyzing tumor samples and blood tests.
Eligibility Criteria
Inclusion Criteria
- Have metastatic, castration-resistant prostate cancer (CRPC).
- Willing to provide a tumor sample from a metastatic site, if possible.
- Show evidence of prostate cancer progression through scans, PSA levels, or symptoms.
- Have low testosterone levels due to surgery or hormone therapy.
- Have a confirmed diagnosis of prostate cancer and an expected lifespan of more than 6 months.
- Be in good overall health with an ECOG performance status of 0 or 1.
- Meet specific blood count and organ function criteria.
- Agree to use effective birth control methods during the study and for 3 months after.
- Understand and agree to the study requirements and sign a consent form.
- Have stopped certain medications that affect hormone levels before starting the study.
Exclusion Criteria
- Have received chemotherapy for metastatic CRPC before, unless it was for hormone-sensitive cancer and more than 6 months have passed.
- Have taken investigational drugs within 14 days before starting the study.
- Have previously used enzalutamide, ARN-509, or cabazitaxel.
- Have a high risk of bone fractures or spinal cord issues.
- Have severe allergies to similar drugs or components of enzalutamide.
- Are taking certain medications that affect liver enzymes without a washout period.
- Have uncontrolled illnesses or conditions that could interfere with the study.
- Have a history of seizures or conditions that increase seizure risk.
- Have had unexplained fainting or mini-strokes recently.
- Are using herbal supplements that affect PSA levels.
- Have another active cancer, except for certain skin or bladder cancers.
- Have digestive issues that affect drug absorption.
- Are on other hormone-affecting therapies, except for megestrol for hot flashes.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| OHSU Knight Cancer Institute | 97239 | Portland | Oregon |
| Portland VA Medical Center | 97239 | Portland | Oregon |
| Seattle Cancer Care Alliance | 98109 | Seattle | Washington |
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