Study on the Effectiveness and Safety of Apalutamide with Radiation Therapy for High-Risk Prostate Cancer
Sponsor: Aragon Pharmaceuticals, Inc.
ClinicalTrials ID:NCT02531516
This clinical trial is exploring whether adding the drug apalutamide to standard hormone therapy can improve outcomes for men with high-risk prostate cancer who are receiving radiation therapy. The study aims to see if this combination can help prevent the cancer from spreading.
Patient Parameters
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Program Overview
The purpose of this study is to find out if using apalutamide along with a hormone therapy called GnRH agonist can improve the time patients with high-risk prostate cancer live without the cancer spreading. This is being tested in men who are receiving radiation therapy as their primary treatment. The study uses imaging tests reviewed by independent experts to assess the results.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 years or older.
- Scheduled to receive radiation therapy for prostate cancer.
- Diagnosed with a specific type of prostate cancer (adenocarcinoma) with certain characteristics, such as a high Gleason score or high PSA levels.
- Have a Charlson index score of 3 or less, indicating overall health status.
- Have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
- Have normal liver and kidney function, and adequate blood cell counts.
- Agree to use condoms during the study and not donate sperm.
- Able to swallow tablets.
- Have signed a consent form agreeing to participate.
Exclusion Criteria
- Cancer has spread to distant parts of the body (except certain pelvic lymph nodes).
- Previous hormone therapy for more than 3 months.
- Previous removal of both testicles.
- History of pelvic radiation.
- Previous treatments like chemotherapy or surgery for prostate cancer.
- History of seizures or conditions that increase seizure risk.
- Previous treatment with certain prostate cancer medications.
- Recent use of certain medications or treatments, including investigational drugs.
- Major surgery within the last 4 weeks.
- Conditions affecting drug absorption.
- Allergies to study medications or their components.
- Any other condition that the study doctor believes would make participation unsafe.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Homewood | Alabama | ||
| Chandler | Arizona | ||
| Scottsdale | Arizona | ||
| Tucson | Arizona | ||
| Bakersfield | California | ||
| Los Angeles | California | ||
| Orange | California | ||
| San Bernardino | California | ||
| San Diego | California | ||
| San Francisco | California |
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