This phase Ib trial tests the effect of relugolix and enzalutamide before (neoadjuvant) and after (adjuvant) standard of care surgery and/or radiation therapy in patients with high-risk prostate cancer that has spread to nearby tissue and lymph nodes (locally advanced). Relugolix, a gonadotropin-releasing hormone receptor antagonist, works by decreasing the amount of testosterone (a male hormone) made by the body. This may slow or stop the spread of tumor cells that need testosterone to grow. Enzalutamide, an antiandrogen, is a drug that works by blocking the androgen receptor, found on some prostate tumor cells, to slow the growth of tumor cells. Standard of care may include radical prostatectomy and radiation therapy. Radical prostatectomy is surgery to remove the entire prostate as well as some surrounding tissue, including lymph nodes. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Giving relugolix and enzalutamide before and after standard of care radical prostatectomy and/or radiation therapy may be safe, tolerable, and/or effective in treating patients with high-risk locally advanced prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06130995.
Locations matching your search criteria
United States
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences CenterStatus: Active
Contact: Kelly L. Stratton
Phone: 405-271-6900
PRIMARY OBJECTIVES:
I. To determine the potential dose limiting toxicity (DLTs) and tolerable dose of relugolix and enzalutamide combination in patients with high-risk locally advanced prostate cancer. (Safety lead-in cohort)
II. To determine the pathologic complete response (pCR) rate and/or minimal residual disease (MRD) rate of neoadjuvant androgen deprivation therapy (ADT) of relugolix and enzalutamide in patients with high-risk locally advanced prostate cancer who are candidate for radical prostatectomy (RP). (Phase IB cohort)
SECONDARY OBJECTIVES:
I. To determine the objective response rate (ORR) of neoadjuvant ADT of relugolix and enzalutamide in patients with high-risk locally advanced prostate cancer who are candidate for definitive radiation therapy (RT) or radical prostatectomy.
II. To determine the frequency and severity of adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.
III. To determine prostate specific antigen (PSA) response.
IV. To determine the positive margin rate and the pathologic downgrade rate.
V. To determine the progression free survival (PFS) of patients receiving neoadjuvant relugolix and enzalutamide followed by radical local-regional RT or RP and adjuvant maintenance ADT.
EXPLORATORY/CORRELATIVE OBJECTIVE:
I. To evaluate the quality of life (QOL) data and patient reported outcome (PRO) data.
OUTLINE:
Patients receive neoadjuvant treatment with relugolix orally (PO) once daily (QD) and enzalutamide PO QD of each cycle. Cycles repeat every 3 months for up to 6 months before undergoing standard of care radical prostatectomy and/or radiation therapy. After surgery and/or radiation therapy, patients receive adjuvant therapy with relugolix PO QD and enzalutamide PO QD of each cycle. Cycles repeat every 3 months for up to 18 months in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and magnetic resonance imaging (MRI) or prostate-specific membrane antigen (PSMA) positron emission tomography (PET) throughout the study.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
Lead OrganizationUniversity of Oklahoma Health Sciences Center
Principal InvestigatorKelly L. Stratton
