Phase III Study of DCVAC Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:April 2014
End Date:June 2020

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men With Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy

The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care
Chemotherapy can improve survival times for patients with Metastatic Castration Resistant
Prostate Cancer.


Inclusion Criteria:

- Male 18 years and older

- Histologically or cytologically confirmed prostate adenocarcinoma

- Presence of skeletal, and/or soft-tissue/visceral/nodal metastasis

- Disease progression despite Androgen Deprivation Therapy

- Maintenance of castrate conditions

- Life expectancy of at least 6 months based on Investigator´s judgment.

- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

- At least 4 weeks after surgery or radiotherapy

- A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy

- Recovery from primary local surgical treatment, radiotherapy or orchiectomy

Exclusion Criteria:

- Confirmed brain and/or leptomeningeal metastases

- Current symptomatic cord compression requiring surgery or radiation therapy

- Prior chemotherapy for prostate cancer

- Subjects who are not indicated for chemotherapy treatment with first line Standard of
Care chemotherapy (docetaxel and prednisone)

- Systemic corticosteroids at doses greater than 40mg hydrocortisone daily or equivalent
for any reason other than treatment of prostate cancer (PCa) within the previous 6
months

- Systemic immunosuppressive therapy for any reason

- Treatment with immunotherapy against PCa within the previous 6 months prior to
randomization

- Clinically significant cardiovascular disease

- Active autoimmune disease requiring treatment

- Uncontrolled co-morbidities

- Participation in a clinical trial using experimental therapy within the last 4 weeks
prior to randomization

- Participation in a clinical trial using immunological experimental therapy (e.g.
monoclonal antibodies, cytokines or active cellular immunotherapies) within the last 6
months prior to randomization
We found this trial at
59
sites
Yale Cancer Center
333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Principal Investigator: Daniel Petrylak, MD
Phone: 203-641-9464
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Montefiore Medical Center
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Mount Sinai Hospital
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: William OH, MD
Phone: 212-659-5455
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
?
mi
from
New York, NY
Click here to add this to my saved trials
Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Tomasz Beer, MD
Phone: 503-494-6179
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
Arlington Cancer Center
Arlington, Texas 76012
Principal Investigator: Anwar Khurshid, MD
Phone: 817-261-4906
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Winship Cancer Institute at Emory University
1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Omer Kucuk, MD
Phone: 404-778-5903
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Rocky Mountain Cancer Centers
Aurora, Colorado 80012
Principal Investigator: John Burke, MD
Phone: 303-418-7639
?
mi
from
Aurora, CO
Click here to add this to my saved trials
University of Colorado
Aurora, Colorado 80045
Principal Investigator: Thomas Flaig, MD
Phone: 303-724-0499
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania 19004
Principal Investigator: Laurence Belkoff, MD
Phone: 610-667-0458
?
mi
from
Bala-Cynwyd, PA
Click here to add this to my saved trials
University of Maryland Greenebaum Cancer Center
22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
Principal Investigator: Arif Hussain, MD
Phone: 410-328-7225
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Dana-Farber Cancer Institute
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Lauren Harshman, MD
Phone: 617-632-4524
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
New Jersey Hematology Oncology Associates
Brick, New Jersey 08724
?
mi
from
Brick, NJ
Click here to add this to my saved trials
Ironwood Cancer and Research Centers
Chandler, Arizona 85224
Principal Investigator: Mikhail Shtivelband, MD
Phone: 480-821-2838
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Associates in Oncology and Hematology
Chattanooga, Tennessee 37404
Principal Investigator: Jitendra Gandhi, MD
Phone: 423-622-2337
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
UC Health University of Cincinnati
Cincinnati, Ohio
Principal Investigator: Nagla Karim, MD
Phone: 513-558-2635
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Compassionate Care Research Group, Inc.
Corona, California 92879
Principal Investigator: Evangeline Reyes, MD
Phone: 951-371-2411
?
mi
from
Corona, CA
Click here to add this to my saved trials
Henry Ford Health System
Detroit, Michigan 48202
Principal Investigator: Clara Hwang, MD
Phone: 313-916-1048
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Karmanos Cancer Center
Detroit, Michigan 48202
Principal Investigator: Ulka Vaishampayan, MD
Phone: 313-576-8715
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Cancer Care Associates St. Luke's University and Health Network
Easton, Pennsylvania 18045
Principal Investigator: Sanjiv Agarwala, MD
Phone: 484-503-4500
?
mi
from
Easton, PA
Click here to add this to my saved trials
California Cancer Associates for Research and Excellence
Encinitas, California 92008
Principal Investigator: Edward McClay, MD
Phone: 760-452-3909
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
Fort Belvoir Community Hospital
Fort Belvoir, Virginia 22060
Principal Investigator: Pramvir Verma, MD
Phone: 571-231-3502
?
mi
from
Fort Belvoir, VA
Click here to add this to my saved trials
Compassionate Care Research Group, Inc.
Fountain Valley, California 92708
Principal Investigator: Haresh Jhangiani, MD
Phone: 714-698-0300
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
St. Joseph Heritage Healthcare
Fullerton, California 92835
Principal Investigator: Sanjay Sharma, MD
Phone: 714-446-5652
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Comprehensive Cancer Research Centers of Nevada
Henderson, Nevada 89052
Principal Investigator: Nicholas Vogelzang, MD
Phone: 702-952-3444
?
mi
from
Henderson, NV
Click here to add this to my saved trials
UT Health, Internal Medicine, Division of Oncology
Houston, Texas 77030
Principal Investigator: Robert Amato, MD
Phone: 713-704-3961
?
mi
from
Houston, TX
Click here to add this to my saved trials
Saint Luke's Cancer Institute
Kansas City, Kansas 64111
Principal Investigator: Rakesh Gaur, MD
Phone: 816-932-3300
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Premier Urology Associates, LLC / AdvanceMed Research
Lawrenceville, New Jersey 08648
Principal Investigator: Gary Karlin, MD
Phone: 609-895-0735
?
mi
from
Lawrenceville, NJ
Click here to add this to my saved trials
Hao Wei Zhang MD, Inc.
Los Angeles, California 90033
Principal Investigator: Hao Wei Zhang, MD
Phone: 323-264-7238
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
University of Miami, Sylvester Comprehensive Cancer Center
1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
Principal Investigator: Rakesh Singal, MD
Phone: 305-243-7678
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
?
mi
from
Miami, FL
Click here to add this to my saved trials
Minnesota Oncology and Hematology, PA
Minneapolis, Minnesota 55405
Principal Investigator: Stuart Bloom, MD
Phone: 612-884-6300
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
University of South Alabama Mitchell Cancer Institute
1660 Springhill Avenue
Mobile, Alabama 36604
(251) 665-8000
Principal Investigator: David Clarkson, MD
Phone: 251-445-9816
University of South Alabama Mitchell Cancer Institute USA Mitchell Cancer Institute (MCI) is located in...
?
mi
from
Mobile, AL
Click here to add this to my saved trials
West Virginia University/Mary Babb Randolph Cancer Center
Morgantown, West Virginia 26506
Principal Investigator: Thomas Hogan, MD
Phone: 304-293-4229
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
Carolina Urologic Research Center
823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Principal Investigator: Neal Shore, MD
Phone: 843-839-1679
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
?
mi
from
Myrtle Beach, SC
Click here to add this to my saved trials
The Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
Principal Investigator: Tina Mayer, MD
Phone: 732-235-4296
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
Tulane University
New Orleans, Louisiana 70112
Principal Investigator: Oliver Sartor, MD
Phone: 504-988-6542
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Virginia Oncology Associates
5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Principal Investigator: Mark Fleming, MD
Phone: 757-466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Eastern CT Hematology and Oncololgy Associates
Norwich, Connecticut 06360
Principal Investigator: Dennis Slater, MD
Phone: 860-886-8362
?
mi
from
Norwich, CT
Click here to add this to my saved trials
GU Research Network, LLC
Omaha, Nebraska 68130
Principal Investigator: Luke Nordquist, MD
Phone: 402-991-8468
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Nebraska Cancer Specialists
Omaha, Nebraska 68114
Principal Investigator: Ralph Hauke, MD
Phone: 402-691-6972
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Principal Investigator: Matthew Zibelman, MD
Phone: 215-728-2689
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
UPMC Cancer Center
Pittsburgh, Pennsylvania 15232
Principal Investigator: Leonard Appleman, MD
Phone: 412-623-8962
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Texas Health Physicians Group
Plano, Texas 75093
Principal Investigator: Ruben Saez, MD
Phone: 972-428-4931
?
mi
from
Plano, TX
Click here to add this to my saved trials
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California
Principal Investigator: Amy Law, MD
Phone: 760-568-3613
?
mi
from
Rancho Mirage, CA
Click here to add this to my saved trials
Compassionate Care Research Group, Inc.
Riverside, California 92501
Principal Investigator: Brian Choi, MD
Phone: 951-276-2760
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Associates in Oncology and Hematology
Rockville, Maryland 20850
Principal Investigator: Manish Agrawal, MD
Phone: 240-826-2127
?
mi
from
Rockville, MD
Click here to add this to my saved trials
Utah Cancer Specialists
Salt Lake City, Utah 84106
Principal Investigator: Stephan Kendall, MD
Phone: 801-281-6864
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Universitatsklinikum fur Urologie und Andrologie
Salzburg,
?
mi
from
Salzburg,
Click here to add this to my saved trials
Cancer Care Network of South Texas
San Antonio, Texas 78217
Principal Investigator: Vijay Gunuganti, MD
Phone: 210-656-7177
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Sharp Clinical Oncology Research
San Diego, California 92123
Principal Investigator: Charles Redfern, MD
Phone: 858-939-5062
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Mayo Clinic
Scottsdale, Arizona 85259
Principal Investigator: Alan Bryce, MD
Phone: 855-776-0015
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Virginia Mason Medical Center
Seattle, Washington 98101
(888) 862-2737
Principal Investigator: John Corman, MD
Phone: 206-341-0578
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
SUNY Upstate Medical University
750 East Adams Street
Syracuse, New York 13210
Principal Investigator: Bernard Poiesz, MD
Phone: 315-464-8231
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Northwest Medical Specialties
Tacoma, Washington 98405
Principal Investigator: Robert McCroskey, MD
Phone: 253-200-3147
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Northwest Cancer Specialists, PC
Tualatin, Oregon 97062
Principal Investigator: Ian Schnadig, MD
Phone: 503-885-5411
?
mi
from
Tualatin, OR
Click here to add this to my saved trials
Tyler Hematology Oncology PA
Tyler, Texas 75701
Principal Investigator: Robert Droder, MD
Phone: 903-596-3188
?
mi
from
Tyler, TX
Click here to add this to my saved trials
MedStar Georgetown University Hospital
Washington, District of Columbia 20007
?
mi
from
Washington,
Click here to add this to my saved trials
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas 66205
Principal Investigator: Stephen Williamson, MD
Phone: 913-588-6029
?
mi
from
Westwood, KS
Click here to add this to my saved trials
The Oncology Institute of Hope and Innovation
Whittier, California 90606
Principal Investigator: Eric Cheung, DO
Phone: 562-693-4477
?
mi
from
Whittier, CA
Click here to add this to my saved trials
UMASS Memorial Medical Center
Worcester, Massachusetts 01605
Principal Investigator: William Walsh, MD
Phone: 508-856-3216
?
mi
from
Worcester, MA
Click here to add this to my saved trials