Apalutamide + SBRT for Prostate Cancer
(PILLAR Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRahul Aggarwal, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial studies how well apalutamide, with or without precise radiation therapy (SBRT), works in treating prostate cancer that resists typical hormone treatments. Apalutamide blocks testosterone, which helps slow cancer growth. SBRT uses focused radiation to kill cancer cells while sparing healthy tissue. The goal is to see if combining these treatments is more effective than using apalutamide alone. Apalutamide is a newer anti-androgen drug that has shown promise in improving the effectiveness of radiotherapy in prostate cancer treatment.

Eligibility Criteria

Men over 18 with advanced prostate cancer that's resistant to hormone therapy and hasn't spread beyond five areas, as seen on a PSMA-PET scan. They must have low testosterone despite ongoing treatment, no recent seizures or heart issues, and not be taking certain medications. Participants need normal organ function tests and can't have started other treatments for this stage of cancer.

Inclusion Criteria

Signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial prior to randomization

Absolute neutrophil count (ANC) ≥ 1500/microliter

Platelets ≥ 75,000/microliter without transfusion and/or growth factors in the 3 months prior to randomization

+19 more

Exclusion Criteria

I have or am at risk of having spinal cord compression.

I have stopped taking certain medications and treatments that could affect the trial results.

I haven't had serious heart issues or blood clots in the last 6 months.

+7 more

Participant Groups

The trial is testing the effectiveness of apalutamide, a drug blocking testosterone use by tumor cells, with or without stereotactic body radiation therapy (SBRT), which precisely targets tumors in fewer high-dose treatments causing less damage to healthy tissue.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (apalutamide, SBRT)Experimental Treatment2 Interventions

Participants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Beginning 60 days after first dose of apalutamide, participants also undergo stereotactic body radiation therapy for 1-5 fractions.

Group II: Arm II (SBRT)Active Control1 Intervention

Participants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

Apalutamide is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Erleada for: