Study on Nivolumab, Docetaxel, and Hormonal Therapy for Metastatic Hormone-Sensitive Prostate Cancer
Sponsor: Xiao X. Wei, MD
ClinicalTrials ID:NCT04126070
This clinical trial is exploring a combination of hormonal therapy, chemotherapy, and immunotherapy to treat metastatic hormone-sensitive prostate cancer. The study involves using drugs like androgen deprivation therapy (ADT), docetaxel, and nivolumab.
Patient Parameters
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Program Overview
The purpose of this study is to test a new treatment approach for metastatic hormone-sensitive prostate cancer by combining hormonal therapy, chemotherapy, and immunotherapy. The study drugs include ADT (such as Lupron, Zoladex, or Firmagon), docetaxel, and nivolumab. While ADT is a standard treatment, the combination with docetaxel and nivolumab is considered experimental. The goal is to see if this combination can help the immune system better recognize and fight cancer cells, potentially improving treatment outcomes for patients with this type of prostate cancer.
Description
This is a Phase 2 clinical trial, which means it is testing the safety and effectiveness of a new treatment combination for metastatic hormone-sensitive prostate cancer. The treatment includes hormonal therapy (ADT), chemotherapy (docetaxel), and immunotherapy (nivolumab). While ADT is already approved for this type of cancer, the combination with docetaxel and nivolumab is experimental. The study aims to see if this combination can help the immune system recognize and attack cancer cells more effectively. All participants will receive the same treatment regimen. The study is particularly focused on patients whose tumors may respond well to this treatment strategy.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed prostate cancer with evidence of high-volume metastasis within the last 6 months.
- Cancer has spread to distant areas like bones or other organs.
- Must be 18 years or older.
- Good overall health with a performance status score of 0 to 2.
- Specific blood test results, including PSA and testosterone levels, must meet certain criteria.
- Must have adequate organ and bone marrow function.
- Willingness to provide tumor tissue samples for analysis.
- Must agree to use effective contraception during and after the study.
Exclusion Criteria
- No prior treatment with ADT, chemotherapy, or immunotherapy for prostate cancer, except under specific conditions.
- No previous prostate surgery.
- No participation in other investigational drug studies.
- No history of allergic reactions to study drugs.
- No other active cancers, except for certain skin cancers.
- No uncontrolled illnesses or infections.
- No history of autoimmune diseases, except for certain stable conditions.
- No use of immunosuppressive medications shortly before the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, San Diego | 92093 | La Jolla | California |
| H. Lee Moffitt Cancer Center | 33612 | Tampa | Florida |
| The Johns Hopkins University School of Medicine | 21218 | Baltimore | Maryland |
| Dana Farber Cancer Institute | 02115 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| University of Wisconsin | 53706 | Madison | Wisconsin |
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