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Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer (PrTK03)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01436968
Recruitment Status : Recruiting
First Posted : September 20, 2011
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Advantagene, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: ProstAtak®(AdV-tk) + valacyclovir Biological: Placebo + valacyclovir Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 711 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer
Study Start Date : September 2011
Estimated Primary Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: ProstAtak®
ProstAtak® (AdV-tk) + valacyclovir + radiation therapy +/- ADT
Biological: ProstAtak®(AdV-tk) + valacyclovir

Patients will receive three courses of ProstAtak® each consisting of AdV-tk injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows:

  1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation.
  2. The second injection will be 0-3 days before initiation of radiation therapy.
  3. The third injection will be 15-22 days after the 2nd injection.

The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each AdV-tk injection.

Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification.


Placebo Comparator: Control
Placebo + valacyclovir + radiation therapy +/- ADT
Biological: Placebo + valacyclovir

Patients will receive three courses each consisting of placebo injection + oral valacyclovir. Placebo injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows:

  1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation.
  2. The second injection will be 0-3 days before initiation of radiation therapy.
  3. The third injection will be 15-22 days after the 2nd injection.

The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each placebo injection.

Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification.





Primary Outcome Measures :
  1. Disease free survival defined as the time from randomization until the date of the first failure event will be compared for the ProstAtak® arm versus the placebo control arm. The analyses will be based on the intent to treat population. [ Time Frame: Assessed at each visit every 6 months through year 5 until event occurs. ]

Secondary Outcome Measures :
  1. Prostate cancer specific survival and overall survival will be compared for the ProstAtak® arm versus the placebo control arm. [ Time Frame: Assessed at each visit every 6 months through year 5 after which long-term follow up of general health status will continue yearly. ]
  2. PSA nadir will be compared for the ProstAtak® arm versus the placebo control arm. [ Time Frame: Assessed at each visit every 6 months through year 5. ]
  3. Patient reported Health Related Quality of Life outcomes will be collected using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. The change in QOL over time will be compared for the ProstAtak® arm versus the placebo control arm. [ Time Frame: Assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation. ]
  4. The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase (until the completion of radiation). Data on late effects will be collected after radiation completion. [ Time Frame: Assessed at each visit and continuously throughout the study. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436968


Locations
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United States, Arizona
Arizona Oncology Services Foundation Terminated
Multiple Locations, Arizona, United States, 85260
Southern Arizona VA Health Care System Recruiting
Tucson, Arizona, United States, 85723
Contact: Marivic Hansen, RN, BSN    520-792-1450 ext 4122    Marivic.Hansen@va.gov   
Principal Investigator: Maximiliano Sorbellini, MD         
United States, California
VA Northern California Health Care System Recruiting
Mather, California, United States, 95655
Contact: Dana Nanigian, MD    916-366-5471    Dana.Nanigian@va.gov   
Principal Investigator: Dana Nanigian, MD         
Precision Radiation Oncology Recruiting
Tustin, California, United States, 92780
Contact: Paul Kim, MD    949-381-5800    paul.kim@procancercare.com   
Principal Investigator: Paul Kim, MD         
United States, Colorado
Valley View Hospital Recruiting
Glenwood Springs, Colorado, United States, 81601
Contact: Cheryl Page, CCRP    970-384-7574    Cheryl.Page@vvh.org   
Principal Investigator: Peter J. Rossi, MD         
Colorado Clinical Research Recruiting
Golden, Colorado, United States, 80401
Contact: Deborah Aggers    303-985-2550    Daggers@coloradouro.com   
Contact: Jennifer Quinn    303-985-2550    Jquinn@coloradouro.com   
Principal Investigator: David Cahn, MD         
Advanced Urology Active, not recruiting
Parker, Colorado, United States, 80134
United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Jacqueline Quivers    202-243-2294    jquiver1@jhmi.edu   
Sub-Investigator: Curtiland Deville, MD         
United States, Florida
21st Century Oncology Recruiting
Fort Lauderdale, Florida, United States, 33324
Contact: Peggy Mouradian, LPN    954-370-7555    peggy.mouradian@21co.com   
Sub-Investigator: Eric S. Chenven, MD         
21st Century Oncology Recruiting
Lakewood Ranch, Florida, United States, 34202
Contact: Kathleen Richman    941-907-9053    kathleen.richman@21co.com   
Principal Investigator: John Sylvester, MD         
21st Century Oncology Recruiting
Naples, Florida, United States, 34102
Contact: Brittney Decker, RN    239-430-3297    brittney.decker@21co.com   
Sub-Investigator: Chaundre K. Cross, MD         
21st Century Oncology Recruiting
Plantation, Florida, United States, 33324
Contact: Peggy Mouradian, LPN, CCRC    954-370-7555    Peggy.Mouradian@21co.com   
Sub-Investigator: Christopher T. Chen, MD         
Clinical Research Center of Florida Recruiting
Pompano Beach, Florida, United States, 33060
Contact: Jack Herman    954-941-3330    Jack@floridacrc.com   
Principal Investigator: Steven Kester, MD         
James A. Haley Veteran's Hospital Recruiting
Tampa, Florida, United States, 33612
Contact: Aaron Baker    813-972-2000 ext 6268    aaron.baker3@va.gov   
Principal Investigator: Evangelia Katsoulakis, MD         
Florida Urology Partners Recruiting
Tampa, Florida, United States, 33615
Contact: Linda Seibert, BS,CCRC    239-223-4488    linda@gulfcoastcta.com   
Principal Investigator: Osvaldo Padron, M.D.         
United States, Illinois
Jesse Brown VA Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Cindy Chan, MPH    312-569-8962    Cindy.Chan2@va.gov   
Principal Investigator: Roohollah Sharifi, M.D.         
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Fauzia Arif    773-702-2856    farif@radonc.uchicago.edu   
Principal Investigator: Stanley L. Liauw, MD         
Silver Cross Hospital Recruiting
New Lenox, Illinois, United States, 60451
Contact: David De La Torre-dorado    815-300-5838    david.delatorre-dorado@uchospitals.edu   
Sub-Investigator: Daniel Golden, MD         
United States, Louisiana
Southeast Louisiana Veterans Health Care System Recruiting
New Orleans, Louisiana, United States, 70119
Contact: M. Camille Fournet, RN    504-507-2000 ext 66065    mary.fournet@va.gov   
Principal Investigator: Jonathan Silberstein, MD         
United States, Maryland
VA Maryland Health Care System Recruiting
Baltimore, Maryland, United States, 21201
Contact: Ganine Markowitz    410-328-0800    GMarkowitz@som.umaryland.edu   
Principal Investigator: Mohummad M. Siddiqui, MD         
Chesapeake Urology Research Associates Recruiting
Baltimore, Maryland, United States, 21204
Contact: Omitola Odunlami    443-471-5749    oodunlami@chesuro.com   
Contact: Jessica Dyal    443-738-8188    jdyal@chesuro.com   
Principal Investigator: Ronald Tutrone, MD         
The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
Contact: Jessica Leitzel, RN    410-502-9242    Jvogel10@jhmi.edu   
Contact: Terry Caldwell    443-287-1889    caldwte@jhmi.edu   
Principal Investigator: Theodore DeWeese, MD         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Judith A. Travis, RN, CCRC    301-319-2927    judith.a.travis.ctr@mail.mil   
Contact: Cecile Robinson, PA-C, MPH    301-319-2907    cecile.robinson.ctr@mail.mil   
Principal Investigator: Inger L. Rosner, MD, MC         
United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Karen R Longtine    508-856-6970    Karen.Longtine@umassmed.edu   
Principal Investigator: Mitchell H. Sokoloff, MD         
United States, Missouri
Kansas City VA Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Contact: Kara Carlson, CCRC    816-861-4700 ext 57247    KARA.CARLSON@va.gov   
Principal Investigator: Eashwer Reddy, MD         
United States, Nevada
Sheldon Freedman MD, Ltd. Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Jose Medina    702-723-0282 ext 300    JoseMedina@Freedmanurology.com   
Principal Investigator: Sheldon Freedman, MD         
Sub-Investigator: Michael Verni, MD         
VA Sierra Nevada Health Care System Recruiting
Reno, Nevada, United States, 89502
Contact: Barak Perahia, MD    775-786-7200 ext 3400    barak.perahia@va.gov   
Contact: Teresa Ramirez, BN, RN    (775)326-2791    Teresa.Ramirez@va.gov   
Principal Investigator: Barak Perahia, MD         
United States, New Jersey
New Jersey Urology - Englewood Recruiting
Englewood, New Jersey, United States, 07631
Contact: Michael Blizzard    201-510-3178    mblizzard@njurology.com   
Principal Investigator: Eric Margolis, MD         
Sub-Investigator: Glen Gejerman, MD         
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Beth Calvanese       beth.calvanese@hackensackmeridian.org   
Sub-Investigator: Glen Gejerman, MD         
Principal Investigator: Eric Margolis, MD         
New Jersey Urology Cancer Treatment Centers Recruiting
Saddle Brook, New Jersey, United States, 07663
Contact: Ashley Apolo    201-881-1000    aapolo@njurology.com   
Principal Investigator: Eric J. Margolis, MD         
Sub-Investigator: Glen Gejerman, MD         
New Jersey Urology - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Jennifer Pilallis    856-673-1613    jpilallis@dvullc.com   
Principal Investigator: Eric Margolis, MD         
Sub-Investigator: Glen Gejerman, MD         
New Jersey Urology - West Orange Recruiting
West Orange, New Jersey, United States, 07052
Contact: Hardik Rana    201-510-3178    hrana@njurology.com   
Principal Investigator: Eric Margolis, MD         
Sub-Investigator: Glen Gejerman, MD         
United States, New Mexico
New Mexico Oncology Hematology Consultants (NMOHC) Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Christopher Lee    505-822-3851    Clee@nmcca.org   
Principal Investigator: Gregg Franklin, MD, PhD         
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Nick Karnezis    505-272-5237    nkarnezis@salud.unm.edu   
Contact: Mark Fischer       mjfischer@salud.unm.edu   
Principal Investigator: Thomas M. Schroeder, MD         
United States, New York
James J. Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Alison Keller    781-584-9000 ext 5273    AlisonT.Keller@va.gov   
Principal Investigator: Glen McWilliams, MD         
Advanced Radiation Centers of New York (Integrated Medical Professionals) Recruiting
North Hills, New York, United States, 11042
Contact: Michelle Primiano    516-394-9600    mprimiano@imppllc.com   
Principal Investigator: Shawn H. Zimberg, MD         
Associated Medical Professionals of NY, PLLC Recruiting
Syracuse, New York, United States, 13210
Contact: Sarah Faisal    315-558-6619    sfaisal@ampofny.com   
Principal Investigator: Neil F. Mariados, MD         
United States, North Carolina
Durham VA Health Care System Recruiting
Durham, North Carolina, United States, 27705
Contact: Tracey Taylor    919-286-0411 ext 2746    tracey.taylor18@va.gov   
Contact: Jeffrey Gingrick, MD    919-286-0411 ext 6939    Jeffrey.Gingrich@duke.edu   
Principal Investigator: Jeffrey Gingrick, MD         
United States, Ohio
Cincinnati VA Medical Center Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Mary Colleen Rogge, RN       Marycolleen.rogge@va.gov   
Principal Investigator: Krishnanath Gaitonde, MD         
Southwest Urology, Clinical Research Solutions Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Jennifer Kalapis, BS    440-340-9010    jkalapis@crssites.com   
Principal Investigator: Michael T Berte, MD         
United States, Oregon
VA Portland Health Care System Recruiting
Portland, Oregon, United States, 97239
Contact: Christine White    503-220-8262 ext 54931    Christine.White1@va.gov   
Contact: Wesley Stoller    503-220-8262 ext 54931    Wesley.Stoller@va.gov   
Principal Investigator: Mark Garzotto, MD         
Oregon Urology Institute Recruiting
Springfield, Oregon, United States, 97477
Contact: Renee Podesta    514-284-5508    rpodesta@oregonurology.com   
Contact: Danna Cardenas    514-284-5508    danna@oregonurology.com   
Principal Investigator: Bryan Mehlhaff, MD         
United States, Pennsylvania
Lancaster Urology Recruiting
Lancaster, Pennsylvania, United States, 17604
Contact: Dawn Stern    717-393-1771 ext 4544    dawns@lancuro.com   
Contact: Jennifer Nonnemacher    717-393-1771 ext 4544    jennifern@lancuro.com   
Principal Investigator: Paul Sieber, MD         
Sub-Investigator: Leanne Schimke         
Fox Chase Cancer Center Active, not recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Allegheny General Hospital, Allegheny Health Network Withdrawn
Pittsburgh, Pennsylvania, United States, 15212
Triangle Urological Group, Allegheny Health Network Withdrawn
Pittsburgh, Pennsylvania, United States, 15212
Wexford Health and Wellness Pavilion, Cancer Institute Withdrawn
Wexford, Pennsylvania, United States, 15090
United States, South Carolina
Ralph H. Johnson Veterans Affairs Medical Center Recruiting
Charleston, South Carolina, United States, 29401
Contact: Susan Caulder, RN, MSN, CCRC    843-789-7816    Susan.caulder@va.gov   
Principal Investigator: Stephen J. Savage, MD         
United States, Texas
Austin Urology Institute Recruiting
Austin, Texas, United States, 78758
Contact: Karina Garcia    512-349-9889 ext 105    karina@driresearchsite.com   
Contact: Hadie Mendoza    512-349-9889 ext 103    hadie@driresearchsite.com   
Principal Investigator: Koushik Shaw, MD         
VA North Texas Health Care System Recruiting
Dallas, Texas, United States, 75216
Contact: Elonm Gbedey    214-742-8387    Elonm.Gbedey@va.gov   
Principal Investigator: Manoj Reddy, MD         
Urology Clinics of North Texas Terminated
Dallas, Texas, United States, 75231
Dr. Irving Fishman's Office Active, not recruiting
Houston, Texas, United States, 77030
Houston Willowbrook Radiation Oncology Recruiting
Houston, Texas, United States, 77070
Contact: Maegan Glass    281-351-5174    Maegan.Glass@usoncology.com   
Sub-Investigator: Abhilasha Patel, MD         
Dr. Ned Stein's Office Active, not recruiting
Houston, Texas, United States, 77074
South Texas San Antonio VA Healthcare System Recruiting
San Antonio, Texas, United States, 78229-4404
Contact: Alex Aguilera    210-617-5300 ext 13264    alexander.aguilera@va.gov   
Principal Investigator: Michael Liss, MD         
Sub-Investigator: William Jones, MD         
Texas Urology Specialists-The Woodlands Recruiting
The Woodlands, Texas, United States, 77385
Contact: Maegan Glass    281-351-5174    maegan.glass@usoncology.com   
Principal Investigator: Steven W. Sukin, MD         
The Methodist Hospital - The Woodlands Recruiting
The Woodlands, Texas, United States, 77385
Contact: Maegan Glass    281-351-5174    Maegan.Glass@usoncology.com   
Principal Investigator: Steven W Sukin, MD         
Texas Urology Specialists Recruiting
Tomball, Texas, United States, 77375
Contact: Maegan Glass    281-351-5174    Maegan.Glass@usoncology.com   
Principal Investigator: Steven W. Sukin, MD         
United States, Virginia
Hunter Holmes McGuire VA Medical Center Recruiting
Richmond, Virginia, United States, 23249
Contact: Jeanie Eason    804-675-6731    jeanie.eason@va.gov   
Principal Investigator: Michael Chang, MD         
Salem VA Medical Center Recruiting
Salem, Virginia, United States, 24153
Contact: Chris L. Angiletta    540-982-2463 ext 4060    Christopher.angiletta@va.gov   
Principal Investigator: Edgar Castillo, MD         
Urology of Virginia, PLLC Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Leigh Ann Brand, RN    757-452-3464    lbrand@urologyofva.net   
Principal Investigator: Robert Given, MD         
United States, Washington
MultiCare Regional Cancer Center - Gig Harbor Recruiting
Gig Harbor, Washington, United States, 98335
Contact: Stacey Macon    253-403-0791    smmacon@multicare.org   
Principal Investigator: Suraj Singh, MD         
MultiCare Regional Cancer Center - Tacoma Recruiting
Tacoma, Washington, United States, 98405
Contact: Stacey Macon    253-403-0791    smmacon@multicare.org   
Principal Investigator: Suraj Singh, MD         
Puerto Rico
VA Caribbean Healthcare System Recruiting
San Juan, Puerto Rico, 00921
Contact: Vanessa Rivera-Gonzalez    787-641-7582 ext 10483    vanessa.rivera-gonzalez@va.gov   
Principal Investigator: Elizabeth Perazza, MD         
Sponsors and Collaborators
Advantagene, Inc.

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Responsible Party: Advantagene, Inc.
ClinicalTrials.gov Identifier: NCT01436968    
Other Study ID Numbers: PrTK03
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Keywords provided by Advantagene, Inc.:
immunotherapy, cytotoxicity, tumor vaccine, prostate cancer, radiotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Valacyclovir
Antiviral Agents
Anti-Infective Agents