Prostate Cancer - O 002
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
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
- MDACC
- 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