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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

PILLAR Trial Summary

This trial is testing apalutamide with or without radiation therapy to see if it can effectively treat prostate cancer that is no longer responding to hormone therapy.

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.Check my eligibility
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.See study design
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.

PILLAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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My prostate cancer was confirmed by a lab test.
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My prostate cancer is worsening despite hormone therapy, with rising PSA levels.
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I am castrated with low testosterone levels and have been on continuous hormone therapy if medically castrated.
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I haven't received any systemic treatment for castration-resistant prostate cancer.
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I've stopped my first anti-androgen treatment 6 weeks ago and my prostate cancer is still getting worse.
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It's been over 4 weeks or 5 half-lives since my last cancer treatment, excluding LHRH analog or first-generation antiandrogen.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My hemoglobin level is at least 9.0 g/dL without needing transfusions or growth factors in the last 3 months.
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My kidney function is good, with a filtration rate of at least 45 ml/min.

PILLAR Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with undetectable serum prostate-specific antigen (PSA)
Secondary outcome measures
Frequency of treatment-related adverse events (AEs)
Median Time to PSA Progression

PILLAR 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
~780

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,497 Previous Clinical Trials
11,935,663 Total Patients Enrolled
Janssen PharmaceuticalsIndustry Sponsor
78 Previous Clinical Trials
203,533 Total Patients Enrolled
Rahul Aggarwal, MDPrincipal Investigator - University of California, San Francisco
UCSF Medical Center at Parnassus
Northwestern University Medical Sch (Medical School)
22 Previous Clinical Trials
1,384 Total Patients Enrolled

Media Library

Apalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT03503344 — Phase 2
Apalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03503344 — Phase 2
Prostate-Specific Antigen Clinical Trial 2023: Apalutamide Highlights & Side Effects. Trial Name: NCT03503344 — Phase 2
Prostate-Specific Antigen Research Study Groups: Arm I (apalutamide, SBRT), Arm II (SBRT)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this an innovative or revolutionary clinical trial?

"Since 2014, Aragon Pharmaceuticals have sponsored research into Stereotactic Body Radiation Therapy. Following a successful trial involving 982 people in that year, the drug received Phase 3 approval. Currently there are 44 active clinical trials for this therapy being conducted across 552 cities and 38 countries worldwide."

Answered by AI

Is Stereotactic Body Radiation Therapy licensed by the FDA?

"Our assessment at Power assigned Stereotactic Body Radiation Therapy a score of 2, signifying there is evidence for its safety but not yet enough for efficacy."

Answered by AI

Is there still an opportunity to join this clinical research?

"Affirmative. Information from clinicaltrials.gov reveals that this trial, first posted on December 17th 2019, is currently recruiting participants. Approximately 60 individuals are needed at 1 medical centre to take part in the research."

Answered by AI

What has been the experience with Stereotactic Body Radiation Therapy in previous experiments?

"Presently, 44 trials for Stereotactic Body Radiation Therapy are in progress with 15 of those Phase 3. The majority of these tests take place at a single site in South Weymouth, Massachusetts; however, there are 2417 other locations running studies related to this therapy."

Answered by AI

To what extent is participant recruitment for this clinical trial progressing?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively enrolling participants; it was first posted on December 17th 2019 and its most recent modification took place on August 29th 2022. Sixty individuals need to be recruited from a single site for the study's completion."

Answered by AI
~6 spots leftby Jun 2025