This phase II trial studies how well apalutamide works in treating patients with prostate cancer before radical prostatectomy. Androgen can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by lowering the amount of androgen the body makes and may make it less likely for patients to receive radiation therapy after surgery.
PRIMARY OBJECTIVE: I. To determine whether 6 months (24 weeks) of neoadjuvant apalutamide prior to prostatectomy for intermediate risk prostate cancer results in a reduction of aggregate pathologic risk features that drive post-operative radiotherapy recommendations from 35% to 15%. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of 6 months (24 weeks) neoadjuvant apalutamide followed by radical prostatectomy for intermediate risk prostate cancer. II. To estimate the frequency of clinical complete responses and "near" complete responses (currently defined as \< 6 mm total tumor volume). III. To characterize the molecular features of the treated prostate cancers and link them to morphologic characterization. IV. To measure the 3-5 year biochemical recurrence rate of treated patients as a baseline to inform a larger phase III trial. OUTLINE: Patients receive apalutamide orally (PO) daily for 24 weeks in the absence of disease progression or unacceptable toxicity. Within 2 weeks of completing apalutamide, patients undergo radical prostatectomy. After completion of study treatment, patients are followed up at 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
M D Anderson Cancer Center
Houston, Texas, United States
Number of Adverse Surgical Pathology Features at Risk of Pelvic Radiation Therapy
To determine whether 6 months (24 weeks) of neoadjuvant apalutamide prior to prostatectomy for intermediate risk prostate cancer results in a reduction of surgical pathology features at risk of pelvic RT, defined as pT3a, pT3b stage, N1 and/or positive surgical margin. All patients who receive at least 9 weeks of neoadjuvant therapy of apalutamide and undergo radical prostatectomy will be evaluable for the primary endpoint.
Time frame: Assessed at time of surgical specimen microscopic evalution Assessed at time of surgical specimen microscopic evaluation
Safety and Tolerability of 6 Months Neoadjuvant Apalutamide Followed by Radical Prostatectomy
Incidence of treatment emergent adverse events (TEAEs). All patients who receive any dose of apalutamide will be evaluable for safety.
Time frame: From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
Clinical Complete Responses (pT0) and "Near" Complete Responses (<6mm Total Tumor Volume)
The numbers of patients with \<6 mm total tumor volume in their surgical specimens, assessed by study Pathologist.
Time frame: Assessed at time of surgical specimen microscopic evaluation
Biochemical Recurrence Rate
Number of patients who had a PSA value of equal of more than 0.2 ng/dL after surgery and through 3 years of follow up.
Time frame: From surgery through 3-year post-op follow up
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