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Prostate Cancer - C 001

This section provides a listing of all trials that have been conducted within the SUO-CTC including trials that are in process for site selection, active patient recruitment, or closed to patient accrual.

Pending Site Selection

2. “A Multicenter Phase 2 Randomized Open-Label Study of Irradiated Autologous Cellular Vaccine in Men with High Risk Prostate Cancer Following Prostatectomy” N= 200 total enrolled (pre-RP) (Sponsor: CellVax) SUO-CTC PI – Adam Kibel, MD and Dan Lin, MD

Open to Patient Accrual

1. PRIORITY “Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study” N= 1000 global accrual (Sponsor: MDxHealth) SUO-CTC PI – Dan Lin MD, University of Washington Medical Center, Seattle WA

Site Locations:
  • Site selected by MDxHealth
  • SUO-CTC Principal Investitgator
  • Brigham and Women’s
  • Adam Kibel MD
  • Columbia University
  • Sven Wenske MD
  • Huntsman Cancer Institute/University of Utah
  • Will Lowrance MD
  • Johns Hopkins
  • Alan Partin, MD
  • New York University Medical Center
  • Samir Taneja MD
  • Ochsner Clinic Foundation
  • Daniel Canter MD
  • Ohio State University Medical Center
  • Ahmad Shabsigh MD
  • Tulane University Medical Center
  • Jonathan Silberstein MD
  • UC San Diego
  • Chris Kane MD
  • University of Chicago
  • Scott Eggener MD
  • University of Kansas Medical Center
  • Jeffrey Holzbeierlein MD
  • University of Michigan
  • Todd Morgan MD
  • University of North Carolina, Chapel Hill
  • Michael Woods MD
  • University of Oklahoma
  • Michael Cookson MD
  • University of Southern California
  • Sia Daneshmand MD
  • University of Texas Southwestern
  • Yair Lotan MD
  • University of Washington
  • Dan Lin MD
  • Vancouver Prostate Centre
  • Martin Gleave MD
  • Vanderbilt University
  • Sam Chang MD

Open to Patient Accrual

2. PROTEUS PCR3011 “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” N= 350 from US sites; 1500 global accrual (Sponsor: Janssen Pharmaceuticals) SUO-CTC PI – Adam Kibel, MD, Brigham and Women’s, Boston MA

Site Locations:
  • Albany Medical College
  • Alliance Urology Specialists
  • Carolina Urologic Research Center
  • Carolina Urology Partners, PLLC
  • Cedars-Sinai Medical Center
  • Dana Farber Cancer Institute
  • Duke Cancer Institute
  • Emory University
  • Medical University of South Carolina
  • Memorial Sloan-Kettering Cancer Center
  • Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
  • Michigan Institute of Urology
  • Oklahoma City VAMC
  • Prisma Health
  • Ralph H. Johnson Veterans Affairs Medical Center
  • Regional Urology
  • Saint Louis University
  • SUNY Upstate Med Univ
  • The Urology Center of Colorado (TUCC)
  • UC Davis
  • UC San Diego Moores Cancer Center
  • University of California Irvine Medical Center
  • University of California Los Angeles
  • University of Chicago
  • University of North Carolina
  • University of Southern California
  • Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology)
  • Urological Research Network
  • UT Southwestern
  • Vanderbilt University Medical Center
  • Virginia Urology
  • Weill Cornell Medical College

Open to Patient Accrual

3. PRESERVE “NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population: Pivotal Study” N= 118 (Sponsor: AngioDynamics) SUO-CTC PI – Jonathan Coleman, MD, Memorial Sloan Kettering Cancer Center & Arvin K. George, MD, University of Michigan

Site Locations:
  • Brigham and Women's Hospital
  • Duke Cancer Institute
  • Duly Health and Care
  • Fox Chase Cancer Center
  • Mayo Clinic - Rochester
  • Memorial Sloan Kettering Cancer Center
  • Moffitt Cancer Center
  • New York University Urology Associates
  • NIH
  • NorthShore University Health System
  • Northwell Health - Lenox Hill Hospital
  • Rush University Medical Center
  • University of California Irvine Medical Center
  • University of Cincinnati Medical Center
  • University of Colorado Urology Clinic
  • University of Florida Health Shands Hospital
  • University of Michigan Rogel Cancer Center
  • University of Rochester Medical Center
  • University of Texas Southwestern Medical Center
  • Wake Forest Baptist - Urology - Charlois
  • Weill Cornell Medicine

Closed/Completed Accrual

1. PRO-IMPACT “PROspective Study of the IMPACT of a Genomic Test (Decipher™) on Physician and Patient Treatment Consideration and Decisions following Radical Prostatectomy [PRO-IMPACT] (CU-004)” N= 300 (Sponsor: GenomeDX) SUO-CTC PI – Dan Lin MD, University of Washington Medical Center, Seattle WA

SUO-CTC Contribution:

  • 94% of sites (18/19)
  • 94% of patients enrolled (269/284)
  • Arm A – 93% of patients enrolled (148/158)
  • Arm B – 96% of patients enrolled (121/126)
  • Patient Accrual - July 2014 thru February 2016
  • Multiple abstracts accepted for presentation

Closed/Completed Accrual

2. PREVAIL “Phase III Placebo vs. Oral MDV3100 in chemo naïve patients with metastatic Prostate Cancer having failed ADT” N= 1680 global accrual (Sponsor: Medivation)

SUO-CTC was a late entry to the project to add to accrual:

  • 7 SUO-CTC sites o Accrual goal = 80
  • Screened = 86
  • Randomized = 56
  • Patient accrual December 2010 thru December 2011

Closed/Completed Accrual

3. AA302 “A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildy Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer” N= 1000 global accrual (Sponsor: Cougar/Janssen) SUO-CTC PI – Allan Pantuck MD, UCLA Medical Center, Los Angeles CA

SUO-CTC was a late entry to the project to add to accrual:

  • 15 SUO-CTC sites
  • 95 patients accrued
  • Patient accrual April 2009 thru June 2010

Closed/Completed Accrual

4. TITAN “A Phase 3 Randomized, Placebo-controlled, Double-blind Study of JNJ-56021927 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects with Low-volume Metastatic Hormone-sensitive Prostate Cancer (mHSPC) JNJ-56021927” N= 1000 global accrual (Sponsor: Janssen) SUO-CTC PI – Larry Karsh MD, The Urologic Center of Colorado, Denver CO

Site Locations:
  • Arizona Institute of Urology
  • Chesapeake Urology Research Associates
  • First Urology
  • Lancaster Urology
  • Michigan Institute of Urology
  • Montefiore Medical Center
  • Ochsner Clinic Foundation
  • Premier Medical Group
  • Ralph H. Johnson VAMC and Medical University of South Carolina
  • The Urology Center of Colorado
  • Tulane University School of Medicine - Tulane Cancer Center Comprehensive Clinic (TCCCC)
  • University Hospitals Case Medical Center
  • Urology Associates
  • Urology Centers Of Alabama
  • Urology of Virginia, PLCC
  • Urology San Antonio Research
  • Virginia Urology Center
  • W. G. ‘Bill’ Hefner VA Medical Center

Early Termination

1. PCM306 “An Evaluation of the Efficacy of Partial Gland Ablation (PGA) with TOOKAD® Vascular Targeted Photodynamic therapy (VTP) versus Active Surveillance for men with Intermediate Risk Localized Prostate Cancer.” N= 150 US patients from 15-20 sites (Sponsor: Steba Biotech)

Early Termination

2. “A Randomized Phase 2 Study of Cabozantinib (XL184) in Combination with Abiraterone in Chemotherapy-Naïve Subjects with Bone-Metastatic Castration-Resistant Prostate Cancer” N= 280 global accrual (Sponsor: Exelixis) SUO-CTC PI – Neal Shore, MD