What side effects are associated with this type of intervention?

Common treatments for prostate cancer similar to apalutamide (a testosterone blocker) and stereotactic body radiation therapy (SBRT) include androgen deprivation therapy (ADT) and other second-generation androgen receptor inhibitors like enzalutamide. Known side effects of these treatments can include cardiovascular issues, fatigue, anemia, and potential impacts on physical and cognitive function. SBRT, which delivers high-precision radiation, may cause localized side effects such as urinary and bowel symptoms, but generally aims to minimize damage to surrounding healthy tissue.

What prior FDA approvals exist?

FDA-approved treatments for managing prostate-specific antigen (PSA) in prostate cancer include androgen receptor inhibitors like apalutamide, enzalutamide, and darolutamide. These drugs block the androgen receptor signaling pathway, which is essential for prostate cancer cell growth. Additionally, stereotactic body radiation therapy (SBRT) is a precise radiation technique used to target and kill tumor cells while minimizing damage to surrounding tissues. These treatments are particularly relevant for castration-resistant prostate cancer (CRPC).

What other types of research exist?

Promising alternatives to Apalutamide and Stereotactic Body Radiation Therapy for prostate-specific antigen patients include: 1) Bicalutamide 150-mg monotherapy, which has shown quality of life advantages and efficacy in advanced prostate cancer. 2) Androgen Deprivation Therapy (ADT) combined with docetaxel, which has been shown to significantly increase overall survival in high-risk/high-volume metastatic castration-sensitive prostate cancer. 3) ADT combined with abiraterone, which is a preferred approach for locally advanced nonmetastatic prostate cancer and offers benefits over ADT alone. 4) Darolutamide, which is recommended in combination with ADT and docetaxel for high-risk/high-volume metastatic castration-sensitive prostate cancer.

← Back to Search

Antiandrogen

Apalutamide + SBRT for Prostate Cancer (PILLAR Trial)

Phase 2

Waitlist Available

Led By Rahul Aggarwal, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Histologically or cytologically confirmed adenocarcinoma of the prostate

Must not have

Spinal cord compression or impending spinal cord compression

Any of the following within 6 months prior to randomization: Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Apalutamide may cause fatigue, rash, joint pain, falls, fractures, hot flushes, diarrhea; SBRT might lead to skin reactions at the treated site(s), fatigue related to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

Select...

My prostate cancer was confirmed by a lab test.

Select...

My prostate cancer is worsening despite hormone therapy, with rising PSA levels.

Select...

I am castrated with low testosterone levels and have been on continuous hormone therapy if medically castrated.

Select...

I haven't received any systemic treatment for castration-resistant prostate cancer.

Select...

I've stopped my first anti-androgen treatment 6 weeks ago and my prostate cancer is still getting worse.

Select...

It's been over 4 weeks or 5 half-lives since my last cancer treatment, excluding LHRH analog or first-generation antiandrogen.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My hemoglobin level is at least 9.0 g/dL without needing transfusions or growth factors in the last 3 months.

Select...

My kidney function is good, with a filtration rate of at least 45 ml/min.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I have cancer other than skin or superficial bladder cancer that needs treatment.

Select...

I have a history of seizures or conditions that could lead to seizures.

Select...

I do not have conditions like inflammatory bowel disease that make radiation unsafe for me.

Select...

I have cancer that has spread to my lungs or liver, or I need radiation for bone cancer.

Select...

I have a digestive condition that affects how my body absorbs food.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients with undetectable serum prostate-specific antigen (PSA)

Secondary study objectives

Frequency of treatment-related adverse events (AEs)

Median Time to PSA Progression

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apalutamide

FDA approved

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Apalutamide works by blocking the androgen receptor, preventing testosterone from stimulating the growth of prostate cancer cells, which is crucial for reducing tumor progression in castration-resistant prostate cancer. Stereotactic Body Radiation Therapy (SBRT) uses advanced imaging and precise radiation delivery to target and kill tumor cells with minimal damage to surrounding healthy tissue. This combination is significant for PSA patients as it offers a dual approach: hormonal therapy to inhibit cancer cell growth and precise radiation to effectively reduce tumor size, potentially improving treatment outcomes and quality of life.