Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:September 2011

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

A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in
combination with radiation therapy for patients with intermediate-high risk localized
prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing
tumor cells in an immune stimulatory environment induces the body's immune system to detect
and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity
and lower than expected recurrence rates in previous clinical trials. The hypothesis is that
ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer.
Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms
receive standard external beam radiation therapy. Short-term androgen deprivation therapy may
be given but is not required.


Inclusion Criteria include:

- Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients
having only one NCCN high-risk feature

- NCCN Intermediate Risk is defined as having at least one of the following: PSA
10-20 ng/ml, Gleason score =7, T2b-T2c

- High Risk with a single high risk feature is defined as having only one of the
following: PSA>20 ng/ml, Gleason score 8-10, or T3a

- Excluded are those in the following risk groups: Low risk; High risk with more
than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1
or M1

- Planning to undergo standard prostate-only external beam radiation therapy

- ECOG Performance Status 0-2

Exclusion Criteria include:

- Liver disease, including known cirrhosis or active hepatitis

- Patients on systemic corticosteroids (>10mg prednisone per day) or other
immunosuppressive drugs

- Known HIV+ patients

- Regional lymph node involvement or distant metastases

- Patients planning to receive whole pelvic irradiation

- Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be given
for a maximum of 6 months

- Patients who had or plan to have orchiectomy as the form of hormonal ablation

- Known sensitivity or allergic reactions to acyclovir or valacyclovir
We found this trial at
47
sites
Dallas, Texas 75231
Principal Investigator: James S. Cochran, MD
Phone: 214-580-1391
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Thomas M. Schroeder, MD
Phone: 505-272-5237
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Stanley L. Liauw, MD
Phone: 773-702-2856
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
Principal Investigator: Gregg Franklin, MD, PhD
Phone: 505-822-3851
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Baltimore, Maryland 21231
Principal Investigator: Theodore DeWeese, MD
Phone: 410-502-9242
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21201
Principal Investigator: Mohummad M. Siddiqui, MD
Phone: 410-328-0800
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Inger L. Rosner, MD, MC
Phone: 301-319-2927
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Bronx, New York 10468
Principal Investigator: Glen McWilliams, MD
Phone: 781-584-9000
?
mi
from
Bronx, NY
Click here to add this to my saved trials
109 Bee Street
Charleston, South Carolina 29401
Principal Investigator: Stephen J. Savage, MD
Phone: 843-789-7816
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chicago, Illinois 60612
Principal Investigator: Roohollah Sharifi, M.D.
Phone: 312-569-8962
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Fort Lauderdale, Florida 33324
Phone: 954-370-7555
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Glenwood Springs, Colorado 81601
Principal Investigator: Peter J. Rossi, MD
Phone: 970-384-7574
?
mi
from
Glenwood Springs, CO
Click here to add this to my saved trials
Golden, Colorado 80401
Principal Investigator: David Cahn, MD
Phone: 303-985-2550
?
mi
from
Golden, CO
Click here to add this to my saved trials
92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
Principal Investigator: Glen Gejerman, MD
Phone: 551-996-5098
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 713-790-1800
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77074
Phone: 713-776-8888
?
mi
from
Houston, TX
Click here to add this to my saved trials
13215 Dotson Road
Houston, Texas 77070
Phone: 281-351-5174
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kansas City, Missouri 64128
Principal Investigator: Eashwer Reddy, MD
Phone: 816-861-4700
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
8946 77th Terrace East
Lakewood Ranch, Florida 34202
Principal Investigator: John Sylvester, MD
Phone: 941-907-9053
?
mi
from
Lakewood Ranch, FL
Click here to add this to my saved trials
Lancaster, Pennsylvania 17604
Principal Investigator: Paul Sieber, MD
Phone: 717-393-1771
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
6900 Pearl Road
Middleburg Heights, Ohio 44130
Principal Investigator: Michael T Berte, MD
Phone: 440-305-8150
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
8994 East Desert Cove Avenue
Multiple Locations, Arizona 85260
?
mi
from
Multiple Locations, AZ
Click here to add this to my saved trials
Naples, Florida 34102
Phone: 239-430-3297
?
mi
from
Naples, FL
Click here to add this to my saved trials
New Orleans, Louisiana 70112
Principal Investigator: Jonathan Silberstein, MD
Phone: 504-507-2000
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
North Hills, New York 11042
Principal Investigator: Shawn H. Zimberg, MD
Phone: 516-394-9600
?
mi
from
North Hills, NY
Click here to add this to my saved trials
Parker, Colorado 80134
Principal Investigator: Damian Sorce, MD
Phone: 720-457-8362
?
mi
from
Parker, CO
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
Principal Investigator: Eric Horwitz, MD
Phone: 215-728-2994
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
320 East North Avenue
Pittsburgh, Pennsylvania 15212
Principal Investigator: Russell Fuhrer, MD
Phone: 412-359-3826
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
1307 Federal Street
Pittsburgh, Pennsylvania 15212
Phone: 412-359-3826
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plantation, Florida 33324
Phone: 954-370-7555
?
mi
from
Plantation, FL
Click here to add this to my saved trials
Pompano Beach, Florida 33060
Principal Investigator: Steven Kester, MD
Phone: 954-941-3330
?
mi
from
Pompano Beach, FL
Click here to add this to my saved trials
Portland, Oregon 97239
Principal Investigator: Mark Garzotto, MD
Phone: 503-220-8262
?
mi
from
Portland, OR
Click here to add this to my saved trials
Reno, Nevada 89502
Principal Investigator: Barak Perahia, MD
Phone: 775-786-7200
?
mi
from
Reno, NV
Click here to add this to my saved trials
Saddle Brook, New Jersey 07663
Principal Investigator: Eric J. Margolis, MD
Phone: 201-510-3178
?
mi
from
Saddle Brook, NJ
Click here to add this to my saved trials
Salem, Virginia 24153
Principal Investigator: Cengiz Inal, MD
Phone: 540-982-2463
?
mi
from
Salem, VA
Click here to add this to my saved trials
San Antonio, Texas 78229
Principal Investigator: Michael Liss, MD
Phone: 210-617-5300
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Juan, 00921
Principal Investigator: Elizabeth Perazza, MD
Phone: 787-641-7582
?
mi
from
San Juan,
Click here to add this to my saved trials
Springfield, Oregon 97477
Principal Investigator: Bryan Mehlhaff, MD
Phone: 514-284-5508
?
mi
from
Springfield, OR
Click here to add this to my saved trials
Syracuse, New York 13210
Principal Investigator: Neil F. Mariados, MD
Phone: 315-558-6619
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Tampa, Florida 33607
Principal Investigator: Osvaldo Padron, M.D.
Phone: 239-223-4488
?
mi
from
Tampa, FL
Click here to add this to my saved trials
The Woodlands, Texas 77385
Principal Investigator: Steven W Sukin, MD
Phone: 281-351-5174
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
The Woodlands, Texas 77385
Principal Investigator: Steven W. Sukin, MD
Phone: 281-351-5174
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
Tomball, Texas 77375
Principal Investigator: Steven W. Sukin, MD
Phone: 281-351-5174
?
mi
from
Tomball, TX
Click here to add this to my saved trials
Tucson, Arizona 85723
Principal Investigator: Maximiliano Sorbellini, MD
Phone: 520-792-1450
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
2895 Edinger Avenue
Tustin, California 92780
Principal Investigator: Paul Kim, MD
Phone: 949-381-5800
?
mi
from
Tustin, CA
Click here to add this to my saved trials
5255 Loughboro Rd NW
Washington, District of Columbia 20016
(202) 537-4000
Phone: 202-243-2294
Sibley Memorial Hospital Sibley Memorial Hospital, in Northwest Washington, D.C., has a distinguished history of...
?
mi
from
Washington,
Click here to add this to my saved trials
55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Principal Investigator: Mitchell H. Sokoloff, MD
Phone: 508-856-5711
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
?
mi
from
Worcester, MA
Click here to add this to my saved trials