Randomized Controlled Trial of ProstAtak® Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:May 2016

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A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in
patients undergoing active surveillance for localized prostate cancer. ProstAtak® involves
the use of aglatimagene besadenovec (AdV-tk) to kill tumor cells and stimulate 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 been well tolerated in
previous trials in patients with prostate cancer and other tumor types. Biochemical,
pathologic and immune responses have been demonstrated in newly diagnosed and recurrent
prostate cancer. 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 of care active surveillance
evaluations.


Inclusion Criteria include:

- Histologically confirmed adenocarcinoma of the prostate

- Patients choosing active surveillance

- Patients meeting definition of NCCN low risk, intermediate risk OR patients having
only one NCCN high-risk feature

- NCCN Low Risk is defined as having all of the following: PSA < 10 ng/ml, Gleason
≤ 6, T1-T2a

- NCCN Intermediate Risk is defined as having at least one of the following and no
high risk features: 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: High risk with more than 1 high
risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1

- Patients must be planning and medically able to tolerate multiple transrectal
ultrasound guided injections.

- ECOG Performance status 0-2

Exclusion Criteria include:

- Active liver disease, including known cirrhosis or active hepatitis

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

- Known HIV+ patients

- Regional lymph node involvement or distant metastases

- Other current malignancy (except squamous or basal cell skin cancers)

- Other serious co-morbid illness or compromised organ function that, in the opinion of
the investigator, would interfere with treatment or follow up

- Prior treatment for prostate cancer except TURP. If prior TURP, patients must be
deemed able to receive prostate biopsy and multiple intra-prostatic injections by the
investigator

- Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)

- Patients who had or plan to use ADT or have history of an orchiectomy.

- Patients who are planning to undergo radical treatment for prostate cancer within 12
months.

- Known sensitivity or allergic reactions to acyclovir or valacyclovir
We found this trial at
27
sites
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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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Scott Eggener, M.D.
Phone: 773-702-3498
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Albany, New York 12208
Principal Investigator: Rebecca O'Malley, MD
Phone: 518-626-6447
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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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Englewood, New Jersey 07631
Principal Investigator: Eric J. Margolis, MD
Phone: 201-510-3178
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Fort Lauderdale, Florida 33324
Principal Investigator: Eric S. Chenven, MD
Phone: 954-370-7555
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Golden, Colorado 80401
Principal Investigator: David J Cahn, MD
Phone: 303-985-2550
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Michael Stifelman, MD
Phone: 551-996-3068
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Kansas City, Missouri 64128
Principal Investigator: Peter J. Van Veldhuizen, MD
Phone: 816-861-4700
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Lancaster, Pennsylvania 17604
Principal Investigator: Paul Sieber, MD
Phone: 717-393-1771
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15 Vasco de Quiroga
Mexico City, 14080
Phone: +52 (55) 5487 0900
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6900 Pearl Road
Middleburg Heights, Ohio 44130
Principal Investigator: Michael T Berte, MD
Phone: 440-340-8150
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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: 631-963-7700
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Oklahoma City, Oklahoma 73104
Principal Investigator: Kelly Stratton, MD
Phone: 405-271-6900
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1307 Federal Street
Pittsburgh, Pennsylvania 15212
Principal Investigator: Ralph J Miller, MD
Phone: 412-359-3826
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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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Richmond, Virginia 23249
Principal Investigator: Michael Chang, MD
Phone: 804-675-5646
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Salem, Virginia 24153
Principal Investigator: Edgar Castillo D'Andreis, MD
Phone: 540-982-2463
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San Antonio, Texas 78229
Principal Investigator: Michael Liss, M.D.
Phone: 210-617-5300
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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: Christopher Pieczonka, MD
Phone: 315-558-6619
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3380 College Park Drive
The Woodlands, Texas 77384
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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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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