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

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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
Lancaster, Pennsylvania 17604
Principal Investigator: Paul Sieber, MD
Phone: 717-393-1771
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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...
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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...
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Albuquerque, New Mexico 87109
Principal Investigator: Gregg Franklin, MD, PhD
Phone: 505-822-3851
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Baltimore, Maryland 21231
Principal Investigator: Theodore DeWeese, MD
Phone: 410-502-9242
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Baltimore, Maryland 21201
Principal Investigator: Mohummad M. Siddiqui, MD
Phone: 410-328-0800
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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...
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Bronx, New York 10468
Principal Investigator: Glen McWilliams, MD
Phone: 781-584-9000
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109 Bee Street
Charleston, South Carolina 29401
Principal Investigator: Stephen J. Savage, MD
Phone: 843-789-7816
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Chicago, Illinois 60612
Principal Investigator: Roohollah Sharifi, M.D.
Phone: 312-569-8962
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Dallas, Texas 75231
Principal Investigator: James S. Cochran, MD
Phone: 214-580-1391
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Fort Lauderdale, Florida 33324
Phone: 954-370-7555
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Glenwood Springs, Colorado 81601
Principal Investigator: Peter J. Rossi, MD
Phone: 970-384-7574
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Golden, Colorado 80401
Principal Investigator: David Cahn, MD
Phone: 303-985-2550
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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...
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Houston, Texas 77030
Phone: 713-790-1800
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Houston, Texas 77074
Phone: 713-776-8888
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13215 Dotson Road
Houston, Texas 77070
Phone: 281-351-5174
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Kansas City, Missouri 64128
Principal Investigator: Eashwer Reddy, MD
Phone: 816-861-4700
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8946 77th Terrace East
Lakewood Ranch, Florida 34202
Principal Investigator: John Sylvester, MD
Phone: 941-907-9053
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6900 Pearl Road
Middleburg Heights, Ohio 44130
Principal Investigator: Michael T Berte, MD
Phone: 440-305-8150
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8994 East Desert Cove Avenue
Multiple Locations, Arizona 85260
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Naples, Florida 34102
Phone: 239-430-3297
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New Orleans, Louisiana 70112
Principal Investigator: Jonathan Silberstein, MD
Phone: 504-507-2000
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North Hills, New York 11042
Principal Investigator: Shawn H. Zimberg, MD
Phone: 516-394-9600
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Parker, Colorado 80134
Principal Investigator: Damian Sorce, MD
Phone: 720-457-8362
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Philadelphia, Pennsylvania 19111
Principal Investigator: Eric Horwitz, MD
Phone: 215-728-2994
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320 East North Avenue
Pittsburgh, Pennsylvania 15212
Principal Investigator: Russell Fuhrer, MD
Phone: 412-359-3826
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1307 Federal Street
Pittsburgh, Pennsylvania 15212
Phone: 412-359-3826
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Plantation, Florida 33324
Phone: 954-370-7555
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Pompano Beach, Florida 33060
Principal Investigator: Steven Kester, MD
Phone: 954-941-3330
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Portland, Oregon 97239
Principal Investigator: Mark Garzotto, MD
Phone: 503-220-8262
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Reno, Nevada 89502
Principal Investigator: Barak Perahia, MD
Phone: 775-786-7200
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Saddle Brook, New Jersey 07663
Principal Investigator: Eric J. Margolis, MD
Phone: 201-510-3178
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Salem, Virginia 24153
Principal Investigator: Cengiz Inal, MD
Phone: 540-982-2463
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San Antonio, Texas 78229
Principal Investigator: Michael Liss, MD
Phone: 210-617-5300
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San Juan, 00921
Principal Investigator: Elizabeth Perazza, MD
Phone: 787-641-7582
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Springfield, Oregon 97477
Principal Investigator: Bryan Mehlhaff, MD
Phone: 514-284-5508
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Syracuse, New York 13210
Principal Investigator: Neil F. Mariados, MD
Phone: 315-558-6619
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Tampa, Florida 33607
Principal Investigator: Osvaldo Padron, M.D.
Phone: 239-223-4488
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The Woodlands, Texas 77385
Principal Investigator: Steven W Sukin, MD
Phone: 281-351-5174
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The Woodlands, Texas 77385
Principal Investigator: Steven W. Sukin, MD
Phone: 281-351-5174
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Tomball, Texas 77375
Principal Investigator: Steven W. Sukin, MD
Phone: 281-351-5174
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Tucson, Arizona 85723
Principal Investigator: Maximiliano Sorbellini, MD
Phone: 520-792-1450
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2895 Edinger Avenue
Tustin, California 92780
Principal Investigator: Paul Kim, MD
Phone: 949-381-5800
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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...
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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...
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