Study on Adding Docetaxel to Usual Hormonal Therapy and Apalutamide for Metastatic Prostate Cancer
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT06931340
This clinical trial is exploring whether adding the chemotherapy drug docetaxel to the usual treatment of hormonal therapy and apalutamide can better treat prostate cancer that has spread to other parts of the body.
Patient Parameters
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Program Overview
This study is testing if adding the chemotherapy drug docetaxel to the standard treatment of hormonal therapy and apalutamide can improve outcomes for men with prostate cancer that has spread beyond the prostate. Docetaxel works by stopping cancer cells from growing and dividing. Hormonal therapy reduces male hormones that help prostate cancer grow, and apalutamide blocks these hormones from affecting cancer cells. The study aims to see if this combination can more effectively treat metastatic prostate cancer compared to the usual treatment alone.
Description
The main goal of this study is to find out if adding docetaxel to hormonal therapy and apalutamide can help men with metastatic prostate cancer live longer. Researchers also want to see if this combination works better for men whose cancer has certain genetic changes. They will look at how long it takes for the cancer to grow or spread, how long patients live without symptoms, and how safe the treatment is.
Participants will be divided into two groups. One group will receive the usual treatment of hormonal therapy and apalutamide, while the other group will receive the same treatment plus docetaxel. The study will monitor how well the cancer responds to the treatments and any side effects.
The study will also explore how the treatment affects quality of life, pain levels, and overall health. Participants will have regular check-ups, scans, and blood tests to track their progress. After completing the treatment, participants will be followed up every six months for up to 10 years to monitor their health and any long-term effects.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of prostate cancer that has spread to other parts of the body.
- Have evidence of metastatic disease based on specific imaging tests.
- Have no more than four bone metastases and no visceral metastases if the disease returned after initial treatment.
- Have next generation sequencing (NGS) results available from a tissue sample.
- Have not received chemotherapy for prostate cancer before.
- Be 18 years or older.
- Have a good performance status, meaning you can carry out daily activities with little or no assistance.
- Have adequate blood cell counts and organ function based on specific lab tests.
- Have no history of seizures or conditions that may lead to seizures.
- Have no uncontrolled high blood pressure.
- Agree to use effective birth control methods during the study and for three months after the last dose of study drug.
- Have no known allergies to the study drugs.
- Not be taking certain medications that interact with the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Kootenai Health - Coeur d'Alene | 83814 | Coeur d'Alene | Idaho |
| Kootenai Clinic Cancer Services - Post Falls | 83854 | Post Falls | Idaho |
| Kootenai Clinic Cancer Services - Sandpoint | 83864 | Sandpoint | Idaho |
| Illinois CancerCare-Bloomington | 61704 | Bloomington | Illinois |
| Illinois CancerCare-Canton | 61520 | Canton | Illinois |
| Illinois CancerCare-Carthage | 62321 | Carthage | Illinois |
| Cancer Care Specialists of Illinois - Decatur | 62526 | Decatur | Illinois |
| Decatur Memorial Hospital | 62526 | Decatur | Illinois |
| Illinois CancerCare-Dixon | 61021 | Dixon | Illinois |
| Crossroads Cancer Center | 62401 | Effingham | Illinois |
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