Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT03902951
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Prostate Adenocarcinoma
  • Prostate Adenocarcinoma With Focal Neuroendocrine Differentiation
  • Recurrent Prostate Carcinoma
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abiraterone Acetate — DRUG
    Given PO
  • Apalutamide — DRUG
    Given PO
  • Leuprolide Acetate — DRUG
    Given SC
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT

Study Details

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.

Key Dates

Start date
Mar 17, 2021
Status verified
Feb 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)
    Patients receive leuprolide SC on day 1, Patients receive a single dose of leuprolide SC on day 1 and apalutamide PO 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 ADT, patients also receive SBRT over 1, 3, or 5 fractions in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Percent of patients achieving a serum prostate specific antigen (PSA) of < 0.05 ng/mL [ Time Frame: Up to 6 months post treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-

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By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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