Study on Darolutamide with Standard Therapy for High-Risk Localized Prostate Cancer
Sponsor: University of Sydney
ClinicalTrials ID:NCT04136353
This clinical trial is testing whether adding the drug darolutamide to standard hormone therapy and radiation can help control prostate cancer that is at a very high risk of coming back after treatment.
Patient Parameters
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Program Overview
The aim of this study is to see if adding darolutamide to the usual hormone therapy and radiation treatment can better prevent prostate cancer from spreading and reduce the risk of death. Darolutamide is a medication that blocks certain hormones that help prostate cancer grow. This study will include men who are receiving radiation therapy for prostate cancer that is very likely to return. The study will also explore if adding another drug, docetaxel, to the treatment can further improve outcomes for patients who are fit enough to receive it.
Description
This trial is designed to find out if using darolutamide along with standard treatments can be more effective in preventing the spread of prostate cancer and reducing deaths. Darolutamide works by blocking hormones that fuel cancer growth and is known to have fewer side effects because it doesn't easily enter the brain. The study will include men who are at a very high risk of their prostate cancer returning after treatment. Participants will receive radiation therapy and hormone therapy, with the option to add the chemotherapy drug docetaxel if they are fit for it. The study will help determine if this combination can better control the cancer and improve survival rates.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 and older with a confirmed diagnosis of prostate cancer.
- Planned for radiation therapy and considered at very high risk for cancer returning based on specific medical criteria, such as high-grade cancer or involvement of lymph nodes.
- Adequate blood, liver, and kidney function as determined by specific medical tests.
- Good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Willing to complete health-related quality of life questionnaires unless unable due to literacy or vision issues.
- Able to start study treatment within 7 days after being assigned to a treatment group.
- Willing to comply with all study requirements, including standard treatments and assessments.
- Signed informed consent to participate in the study.
Exclusion Criteria
- Prostate cancer with non-adenocarcinoma features.
- Cancer spread to lymph nodes outside the pelvis or distant areas.
- Evidence of cancer spread to other parts of the body.
- PSA level over 100 ng/mL at any time.
- Previous use of certain advanced hormone therapies.
- Prior hormone therapy for prostate cancer, except for specific allowed treatments.
- Previous removal of testicles or certain types of radiation therapy.
- Recent history of significant heart or brain conditions.
- Gastrointestinal issues that affect medication absorption.
- History of another cancer within the last 5 years, except for certain low-risk cancers.
- Severe infections or other illnesses that could affect study participation.
- Psychological or social conditions that could interfere with the study.
- Men who are sexually active with women of childbearing potential and not using effective contraception.
- Participation in other clinical trials for prostate cancer or other diseases.
- Major surgery within 21 days before starting the study.
- Allergic reactions to the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Dana Farber Cancer Institute - St. Elizabeth's | 02135 | Brighton | Massachusetts |
| Lahey Hospital and Medical Center | 01805 | Burlington | Massachusetts |
| Dana Farber Cancer Institute - Milford | 01757 | Milford | Massachusetts |
| XCancer Omaha/Urology Cancer Center | 68130 | Omaha | Nebraska |
| Memorial Sloan Kettering Basking Ridge | 07920 | Basking Ridge | New Jersey |
| New Jersey Urology Saddle Brook | 07013 | Clifton | New Jersey |
| Memorial Sloan Kettering Monmouth | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen | 07645 | Montvale | New Jersey |
| New Jersey Urology Voorhees | 08043 | Voorhees Township | New Jersey |
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