Study on Apalutamide for High-Risk Localized or Locally Advanced Prostate Cancer Patients Undergoing Radical Prostatectomy
Sponsor: Janssen Research & Development, LLC
Sponsor score: 60
ClinicalTrials ID:NCT03767244
This clinical trial is exploring whether adding the drug apalutamide to standard hormone therapy before and after prostate surgery can improve outcomes for patients with high-risk prostate cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to find out if using apalutamide along with hormone therapy before and after prostate surgery can help improve the chances of being cancer-free and prevent the cancer from spreading in patients with high-risk localized or locally advanced prostate cancer. The study compares this combination to a placebo with hormone therapy.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate cancer confirmed by lab tests.
- High-risk cancer defined by specific Gleason Score criteria and other factors like PSA levels.
- Eligible for prostate surgery with pelvic lymph node removal.
- Good overall health with a performance status score of 0 or 1.
- Must agree to use contraception if there is a risk of pregnancy.
- Able to undergo hormone therapy for at least 13 months.
Exclusion Criteria
- Cancer that has spread to distant parts of the body.
- Previous treatment with certain prostate cancer drugs or therapies.
- Recent use of investigational drugs or major surgery.
- Recent history of severe heart problems or blood clots.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
| University of Southern California | 90033 | Los Angeles | California |
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
| University of California Los Angeles | 90095 | Los Angeles | California |
| University of California Irvine Medical Center Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| UC Davis Medical Center | 95817 | Sacramento | California |
| AdventHealth Medical Group Urology of Denver | 80210 | Denver | Colorado |
| Colorado Clinical Research | 80228 | Lakewood | Colorado |
| Stamford Hospital | 06904 | Stamford | Connecticut |
| Urology Specialists LLC | 33002 | Hialeah | Florida |
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