This phase II trial studies how well antiandrogen therapy (leuprolide, apalutamide, and abiraterone acetate) and stereotactic body radiation therapy (SBRT) works in treating patients with prostate cancer that has come back and has spread to other parts of the body. Drugs used in chemotherapy, such as leuprolide, apalutamide, and abiraterone acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving antiandrogen therapy and SBRT may work better in treating patients with prostate cancer.
PRIMARY OBJECTIVES: I. To assess the efficacy of combined systemic and tumor directed therapy for recurrent oligometastatic M1a,b prostate cancer patients with 1-5 metastases (exclusive of pelvic nodal N1 metastases) staged by prostate-specific membrane antigen (PSMA) positron emission tomography (PET)-computed tomography (CT). SECONDARY OBJECTIVES: I. Time to biochemical progression. II. Time to additional antineoplastic therapy. III. Prostate cancer specific survival. IV. Safety and tolerability. V. Assessment of health related quality of life using the Functional Assessment of Cancer Therapy - Prostate (FACT-P) scale. CORRELATIVE OBJECTIVES: I. To determine genomic and transcriptomic features present in metastatic tumors in patients that respond to this multimodal therapy. II. To evaluate biomarkers of response using circulating tumor cells (CTCs). III. To evaluate biomarkers of response using circulating tumor deoxyribonucleic acid (DNA) (ctDNA). IV. To evaluate immunophenotypes of circulating immune cells. OUTLINE: Patients receive a single dose of leuprolide subcutaneously (SC) on day 1 and apalutamide orally (PO) once daily (QD) and abiraterone acetate PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning 2 months of initiation of antiandrogen therapy (ADT), patients also receive SBRT over 1, 3, or 5 fractions in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 2 -4 weeks, every 30 days for 6 months, and then every 3 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Given PO
Given PO
Given SC
Ancillary studies
Ancillary studies
Undergo SBRT
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Percent of patients achieving a serum prostate specific antigen (PSA) of < 0.05 ng/mL
Will be summarized by count and percent along with the 95% confidence interval.
Time frame: Up to 6 months post treatment
Time to biochemical progression
Will be summarized using Kaplan-Meier method.
Time frame: Baseline to first rise in PSA to 0.2 ng/mL, assessed up to 2 years
Time to radiographic progression
Will be summarized using Kaplan-Meier method.
Time frame: Baseline to time when any imaging shows new evidence of metastatic disease, assessed up to 2 years
Time to initiation of alternative antineoplastic therapy
Will be summarized using Kaplan-Meier method.
Time frame: Baseline to time when new anti-prostate cancer therapy is initiated, assessed up to 2 years
Prostate cancer specific survival
Time frame: Up to 2 years post treatment
Health related quality of life: Functional Assessment of Cancer Therapy - Prostate (FACT-P) scale - patient questionnaire
This uses the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire. It assesses patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Items are rated on a 0 to 4 Likert type scale and combined to produce subscale scores for each domain and a global score, the higher the score, the better the quality of life. Range from 0-150 . Data will be aggregated per patient and over time.
Time frame: Up to 2 years post treatment
Incidence of adverse events
The intensity of clinical adverse events will be graded according to the Common Terminology Criteria for Adverse Events version (v) 4.0 (CTCAE) grading system in the toxicity categories.
Time frame: Up to 30 days post treatment
Biomarker analysis
Will conduct whole exome deep sequencing (WES), RNA sequencing (RNA-seq), and comparative genomic hybridizations (CGH) of the metastatic tumors.
Time frame: Up to 2 years post treatment
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