• UCLA Health
  • myUCLAhealth
  • School of Medicine
Institute of Urologic Oncology

UCLA Institute of Urologic Oncology

Institute of Urologic Oncology
  • About Us
    • Director's Welcome
    • Board of Directors
    • IUO in the News
    • Why Choose the UCLA IUO
    • Support the IUO
    • Contact Us
    • The Wasserman Building
    • Maps and Directions
    • IUO Membership Information
    • Administrative & Research Staff
    • Positions Available
  • Clinical Programs
    • Bladder Cancer
    • Kidney Cancer
    • Prostate Cancer
    • Testicular Cancer
    • Integrated Cancer Program
  • Research Programs
    • Clinical Trials
    • Faculty Labs
    • Bladder Cancer
    • Kidney Cancer
    • Prostate Cancer
    • SPORE In Prostate Cancer
    • External Funding Opportunities
  • Clinical Trials
    • What Is a Clinical Trial?
    • Who Should Consider Clinical Trials & Why
    • Bladder Cancer Clinical Trials
    • Kidney Cancer Clinical Trials
    • Prostate Cancer Clinical Trials
    • Clinical Research Team
    • IUO Membership Study Information
  • For Patients
    • Contact Us
    • Clinical Updates
    • Health Plans and Financial Matters
    • Maps and Directions
    • myUCLAhealth
    • Patient Testimonials
    • Preparing for Surgery
    • Webinars / Videos
  • Fellowship
    • Current Fellows
    • Former Fellows
    • Fellow Testimonials
    • UCLA Health Aerial Tour
  • For Healthcare Professionals
    • How to Refer a Patient
    • Lectures & Conferences
    • CTSI Distinguished Speaker Seminar Series
    • DGSOM Research Seminars
    • DGSOM Events
    • JCCC Seminars
    • SPORE Lectures
    • External Funding Opportunities
  • Expert Team
    • Board of Directors
  • UCLA Health
  • myUCLAhealth
  • School of Medicine

UCLA Institute of Urologic Oncology

Clinical Trials

Clinical Trials

Clinical Trials

  • What Is a Clinical Trial?
  • Who Should Consider Clinical Trials & Why
  • Bladder Cancer Clinical Trials
  • Kidney Cancer Clinical Trials
  • Prostate Cancer Clinical Trials
  • Clinical Research Team
  • IUO Membership Study Information
  • What Is a Clinical Trial?
  • Who Should Consider Clinical Trials & Why
  • Bladder Cancer Clinical Trials
  • Kidney Cancer Clinical Trials
  • Prostate Cancer Clinical Trials
  • Clinical Research Team
  • IUO Membership Study Information
  1. Home
  2. Institute of Urologic Oncology
  3. Clinical Trials
  4. A Study for Men with Prostate Cancer who are Candidates for Radical Prostatectomy

A Study for Men with Prostate Cancer who are Candidates for Radical Prostatectomy

Share this

Janssen PCR3011

Lay Title: A Study for Men with Prostate Cancer who are Candidates for Radical Prostatectomy
Technical Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy 

Disease Type: High-risk prostate cancer that is localized or locally advanced

Basic information: The purpose of this study is to see if the study drug, apalutamide, plus androgen deprivation therapy (ADT, also known as hormone therapy) is safe; if it can improve the results of radical prostatectomy (surgery to remove the prostate and surrounding tissue); and if it delays the spread of prostate cancer to other parts of the body.

Participants will be randomized to be in one of two treatment groups:
Group 1: ADT + placebo
Group 2: ADT + study drug (apalutamide)

ADT is not routinely given to patients before RP and has not been proven to work. It is, however, routinely given to patients after RP.

Research Procedures (not a complete list):
The study is divided into 3 parts:
Part 1 (6 months): Treatment with ADT with or without apalutamide before radical prostatectomy. The aim is to reduce the size of the prostate to make surgery more effective.
Part 2: Radical prostatectomy, which is performed as part of your usual care.
Part 3: Resume treatment with ADT with or without study drug. The aim is to reduce the chance that prostate cancer could come back.

You will need to come to the clinic once a month while you are on the study. Depending on the visits, you will undergo assessments such as physical exam, lab draws, ECG, and be asked to complete questionnaires.

Eligibility Criteria (not a complete list):
Inclusion Criteria:

  • High-risk disease with a Gleason Sum Score ≥4+3. Please call our team to see if you meet the sponsor’s definition of high-risk.
  • Candidate for radical prostatectomy with pelvic lymph node dissection

Exclusion Criteria:

  • Distant metastasis
  • Prior treatment with androgen receptor agonists
  • Bilateral orchiectomy (removal of testicles)

For More Detailed Information, Contact:

  • Robert Reiter, MD, Principal Investigator, Professor of UCLA Urology
  • Ankush Sachdeva, Study Coordinator, (310) 794-3421

Read more about this study (NCT03767244) on ClinicalTrials.gov.

Like Us on Facebook Follow Us on Twitter Subscribe to Our Videos on YouTube Follow us on Instagram Connect with Us on LinkedIn Follow us on Pinterest
UCLA Health hospitals ranked best hospitals by U.S. News & World Report
  • UCLA Health
  • Find a Doctor
  • School of Medicine
  • School of Nursing
  • UCLA Campus
  • Directory
  • Newsroom
  • Subscribe
  • Patient Stories
  • Giving
  • Careers
  • Volunteer
  • International Services
  • Privacy Practices
  • Nondiscrimination
  • Billing
  • Health Plans
  • Emergency
  • Report Broken Links
  • Terms of Use
  • 1-310-825-2631
  • Maps & Directions
  • Contact Us
  • Your Feedback
  • Report Misconduct
  • Get Social
  • Sitemap
Like Us on Facebook Follow Us on Twitter Subscribe to Our Videos on YouTube Follow us on Instagram Connect with Us on LinkedIn Follow us on Pinterest