This phase II trial studies the effect of abemaciclib and androgen deprivation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) and is high-risk, or has spread to nearby tissue or lymph nodes (locally advanced). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Since prostate cancer is driven prominently by high testosterone levels, drugs used in androgen deprivation therapy, such as goserelin acetate and leuprolide acetate, act to reduce the levels of testosterone and thus slow the growth of prostate cancer. Abemaciclib may work with androgen deprivation therapy to control growth and spread of prostate cancer so as to make the patient’s tumor better receptive to radiation therapy and improve outcomes to radiation therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04298983.
PRIMARY OBJECTIVE:
I. To assess clinical response rates using proportion of patients with prostate-specific antigen (PSA) nadir of =< 0.5 ng/ml on treatment.
SECONDARY OBJECTIVES:
I. Proportion of patients with PSA declines prior to radiotherapy.
II. Time to PSA failure.
III. To study the tolerability and feasibility of combining abemaciclib with androgen deprivation therapy (ADT) for localized high risk or locally advanced prostate cancer.
EXPLORATORY OBJECTIVES:
I. Magnetic resonance imaging (MRI)-ultrasound (US) fusion imaging pre-treatment and at 6 months post radiation therapy (RT) with comparison with historical controls receiving RT + ADT.
II. Baseline (mandatory) and 6 months (optional) post RT tumor tissue profiling (MRI-US fusion guided) to identify association of molecular profile with PSA decline at 1 year.
III. Baseline, pre-radiotherapy and 6 months post-RT blood collection and profiling for molecular analysis.
OUTLINE:
Patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28 (days 1-14 of cycle 3). Patients also receive goserelin acetate subcutaneously (SC), leuprolide acetate intramuscularly (IM) or SC, or other ADT luteinizing hormone-releasing hormone (LHRH) agents SC on day 1. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care RT. Beginning 1 month after completion of RT, patients receive abemaciclib PO BID on days 1-28. Patients also receive goserelin acetate SC, leuprolide acetate IM or SC, or other ADT LHRH agents SC on day 1. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 12 months.
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorEddy Shih-Hsin Yang
