A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

Last Updated   November 5, 2021 - 00:00

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OVERVIEW

  • Gender
    male
  • Age
    18+ years
  • Phase
    phase 2
    The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety.
  • Sites
    32 sites
  • Status
    Recruiting

SUMMARY

Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate.<br>Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.

CONDITIONS

  • Prostate Cancer

ELIGIBILITY

Inclusion Criteria:

  • • A candidate for radical prostatectomy (RP) or status post RP. Eligible to receive study intervention between Day 29 and Day 90 post-RP. Post RP prostate-specific antigen (PSA) of <= 0.2 nanograms per milliliter (ng/mL). Has not received other treatment for prostate cancer
  • • Have recovered from RP procedure and have had no worsening in cardiac risk in the peri-operative period per the clinical judgement of the investigator
  • • Adequate organ function (hepatic, renal, hematologic and cerebral) determined at the discretion of the treating physician
  • • Eastern Cooperative oncology Group (ECOG) Performance Status Score of 0 or 1
  • • Histologically confirmed adenocarcinoma of the prostate and categorized as high risk for recurrent prostate cancer. High risk can be defined based on PSA alone or biopsy or RP specimen as follows: PSA greater than or equal to (>=) 20 ng/ml or; Gleason Score >= 9 in any core on biopsy or; Gleason Score >= 8 (4+4 or 5+3) in greater than (>) 80 percentage (%) of 2 cores on biopsy or; Gleason Score = 8 (4+4 or 5+3) in 1 core as long 5 or more other cores with minimum Gleason Score of 4+3 on biopsy. The determination of high risk may be based on pathology report of biopsy or equivalent criteria from radical prostatectomy

Exclusion Criteria:

  • • History or presence of soft tissue/bone metastasis or metastasis in distant lymph nodes (pelvic lymph nodes below the iliac bifurcation that are less than (<) 2 centimeter (cm) in diameter [short axis] either radiographically or pathologically are allowed.)
  • • History of bilateral orchiectomy
  • • Received an investigational intervention <= 4 weeks before the planned first dose of study intervention
  • • History of seizure or any condition that in the opinion of the investigator may predispose to seizure or treatment with drugs known to lower the seizure threshold within 4 weeks prior to starting treatment with apalutamide
  • • Allergy or hypersensitivity to apalutamide, or excipients, unable or unwilling to take androgen deprivation therapy (ADT)

DETAILS

LOCATIONS

Locations in:
United States
City or Province (32) Country (1) Status
Troy, MI Michigan Institute of Urology, PC United States
Recruiting
Tucson, AZ Arizona Institute of Urology United States
Recruiting
Myrtle Beach, SC Carolina Urologic Research Center United States
Recruiting
San Antonio, TX Urology San Antonio Research United States
Recruiting
Little Rock, AR Arkansas Urology United States
Recruiting
Tucson, AZ Urological Associates of Southern Arizona, P.C. United States
Recruiting
Shreveport, LA Regional Urology United States
Recruiting
Houston, TX Houston Metro Urology United States
Recruiting
Jeffersonville, IN First Urology, PSC United States
Recruiting
Virginia Beach, VA UROLOGY OF VIRGINIA, PLLC United States
Recruiting
Richmond, VA Virginia Urology United States
Recruiting
Raleigh, NC Associated Urologists of North Carolina United States
Recruiting
Wichita, KS Wichita Urology Group United States
Recruiting
Denver, CO The Urology Center of Colorado United States
Recruiting
Springfield, OR Oregon Urology Institute United States
Recruiting
Cheektowaga, NY Great Lakes Physician PC d/b/a Western New York Urology Associates United States
Recruiting
Sherman Oaks, CA SKYLINE UROLOGY United States
Recruiting
Torrance, CA SKYLINE UROLOGY United States
Recruiting
Cincinnati, OH The Urology Group United States
Recruiting
Syracuse, NY Associated Medical Professionals United States
Recruiting
Meridian, ID Idaho Urologic Institute United States
Recruiting
Nashville, TN Urology Associates United States
Recruiting
Omaha, NE Adult Pediatric Urology & Urogynecology, P.C United States
Recruiting
Lancaster, PA Lancaster Urology United States
Recruiting
West Des Moines, IA The Iowa Clinic United States
Recruiting
Spokane, WA Spokane Urology United States
Recruiting
Bala Cynwyd, PA MidLantic Urology United States
Recruiting
Austin, TX Urology Austin United States
Recruiting
Lakewood, CO Foothills Urology - Golden Off United States
Recruiting
West Columbia, SC Lexington Urology United States
Recruiting
Voorhees, NJ New Jersey Urology LLC United States
Recruiting
Hialeah, FL Urological Research Network United States
Recruiting
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5

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Corresponds to individual site.

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