Study on Relugolix and Enzalutamide with Radiation Therapy for Treating Very High Risk Prostate Cancer (OPTIMAL Trial)
Sponsor: Northwestern University
ClinicalTrials ID:NCT06499870
This clinical trial is exploring how well a combination of two medications, relugolix and enzalutamide, along with radiation therapy, works in treating patients with very high risk prostate cancer. The study aims to see if this combination is more effective than using any of these treatments alone.
Patient Parameters
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Program Overview
This phase II study is testing a new treatment approach for patients with very high risk prostate cancer. It combines two medications, relugolix and enzalutamide, with radiation therapy. Relugolix helps lower testosterone levels, which prostate cancer cells need to grow. Enzalutamide blocks signals that help cancer cells grow. Radiation therapy uses high-energy rays to kill cancer cells. The study aims to find out if this combination can better control prostate cancer compared to using each treatment separately.
Description
The main goal of this study is to see how effective the combination of radiation therapy, relugolix, and enzalutamide is in treating very high risk prostate cancer over 18 months. Researchers will look at how many patients have no signs of cancer in a biopsy after two years.
Secondary goals include checking how long patients stay free of cancer and how well testosterone levels recover after treatment.
The study will also explore how the treatment affects patients' quality of life and use imaging tests to see how the cancer responds to treatment.
Participants will take relugolix and enzalutamide pills daily for up to 18 months. After four months, they will start radiation therapy. Throughout the study, patients will have various tests, including blood samples and imaging scans, to monitor their health and the treatment's effects.
After finishing the treatment, patients will have follow-up visits every 3-6 months for up to 30 months to check on their health and any signs of cancer returning.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of very high risk prostate cancer based on specific medical criteria.
- Must be 18 years or older.
- Must have testosterone levels above 50 ng/dL within 90 days before joining the study.
- Must have a good overall health status, with an ECOG performance score of 0-2.
- Must have adequate blood cell counts and organ function as determined by specific blood tests.
- Must not have any conditions that prevent them from undergoing MRI or radiation therapy.
- Must agree to use effective contraception during and for three months after treatment if they have a partner who can become pregnant.
- Must be able to understand and agree to the study requirements and sign a consent form.
Exclusion Criteria
- Must not have any signs of cancer spreading to other parts of the body.
- Must not have had another invasive cancer within the past two years, except for certain non-threatening cancers.
- Must not have had previous radiation therapy that would overlap with the study's radiation treatment.
- Must not have certain medical conditions, such as inflammatory bowel disease, severe heart problems, or a history of seizures.
- Must not have any conditions that would prevent them from taking oral medications or absorbing them properly.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northwestern University | 60611 | Chicago | Illinois |
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