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

This study is currently recruiting participants.
Verified October 2017 by Advantagene, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01436968
First Posted: September 20, 2011
Last Update Posted: October 6, 2017
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.
Information provided by (Responsible Party):
Advantagene, Inc.
  Purpose
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 Intervention Phase
Prostate Cancer Biological: ProstAtak®(AdV-tk) + valacyclovir Biological: Placebo + valacyclovir Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Advantagene, Inc.:

Primary Outcome Measures:
  • 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:
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Estimated Enrollment: 711
Study Start Date: September 2011
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
United States, Arizona
Arizona Oncology Services Foundation Active, not recruiting
Multiple Locations, Arizona, United States, 85260
United States, Colorado
Foothills Urology Recruiting
Golden, Colorado, United States, 80401
Contact: Deborah Aggers    303-985-2550    deb@foothillhsurologypc.com   
Contact: Jennifer Quinn    303-985-2550    jennifer@foothillsurologypc.com   
Principal Investigator: David Cahn, MD         
Advanced Urology Active, not recruiting
Parker, Colorado, United States, 80134
United States, District of Columbia
Sibley Memorial Hospital Not yet recruiting
Washington, D.C., District of Columbia, United States, 20016
Contact: Jo Hurtt    202-660-5772    jhurtt2@jhmi.edu   
Principal Investigator: Curtiland Deville, MD         
United States, Maryland
The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
Contact: Kristi Penn, RN    410-502-9242    kpurcel2@jhmi.edu   
Contact: Helen Kim    410-614-3950    hkim91@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   
Principal Investigator: Inger L. Rosner, MD, MC         
United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Margaret R Humphries, RN, CCRC    508-856-5711    Margaret.Humphries@umassmed.edu   
Principal Investigator: Mitchell H. Sokoloff, 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   
Contact: Andrea Yost    505-243-4039    research@nmohc.com   
Principal Investigator: Gregg Franklin, MD, PhD         
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Melissa Gibson    505-272-5237    mngibson@salud.unm.edu   
Contact: Susan Lopez    505-925-0375    slopez@salud.unm.edu   
Principal Investigator: Thomas M. Schroeder, MD         
United States, New York
Advanced Radiation Centers of New York Recruiting
Hartsdale, New York, United States, 10530
Contact: Michelle Primiano    516-932-6008    mprimiano@imppllc.com   
Principal Investigator: Shawn H. Zimberg, MD         
Advanced Radiation Centers of New York Recruiting
Hauppauge, New York, United States, 11749
Contact: Michelle Primiano    516-932-6008    mprimiano@imppllc.com   
Principal Investigator: Shawn H. Zimberg, MD         
Memorial Sloan Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
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         
Advanced Radiation Centers of New York Recruiting
Plainview, New York, United States, 11803
Contact: Michelle Primiano    516-932-6008    mprimiano@imppllc.com   
Principal Investigator: Shawn H. Zimberg, MD         
Advanced Radiation Centers of New York Recruiting
The Bronx, New York, United States, 10461
Contact: Michelle Primiano    516-932-6008    mprimiano@imppllc.com   
Principal Investigator: Shawn H. Zimberg, MD         
Advanced Radiation Centers of New York Recruiting
West Nyack, New York, United States, 10994
Contact: Michelle Primiano    516-932-6008    mprimiano@imppllc.com   
Principal Investigator: Shawn H. Zimberg, MD         
United States, Ohio
Southwest Urology, Clinical Research Solutions Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Sara Heider, BS    440-340-9010    sheider@crssites.com   
Principal Investigator: Michael T Berte, 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, MD         
Fox Chase Cancer Center Active, not recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Allegheny General Hospital, Allegheny Health Network Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Park Bogan    412-359-3748    Park.Bogan@AHN.ORG   
Contact: Andrea Fabian, RN    412-359-6452    andrea.fabian@ahn.org   
Principal Investigator: Russell Fuhrer, MD         
Triangle Urological Group, Allegheny Health Network Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Park Bogan    412-359-3748    Park.Bogan@AHN.ORG   
Contact: Andrea Fabian, RN    412-359-6452    andrea.fabian@ahn.org   
Sub-Investigator: Ralph J Miller, MD         
United States, Texas
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 Elliott    281-351-5174    Maegan.elliott@usoncology.com   
Contact: Chase Authement    281-351-5174    Chase.Authement@usoncology.com   
Sub-Investigator: Abhilasha Patel, MD         
Dr. Ned Stein's Office Active, not recruiting
Houston, Texas, United States, 77074
Millennium Radiation Center - The Woodlands Recruiting
The Woodlands, Texas, United States, 77380
Contact: Maegan Elliott    281-351-5174    Maegan.elliott@usoncology.com   
Contact: Chase Authement    281-351-5174    Chase.Authement@usoncology.com   
Sub-Investigator: Jason Berilgen, MD         
Texas Urology Specialists Recruiting
Tomball, Texas, United States, 77375
Contact: Maegan Elliott    281-351-5174    Maegan.elliott@usoncology.com   
Contact: Chase Authement    281-351-5174    Chase.authement@usoncology.com   
Principal Investigator: Steven W. Sukin, MD         
Sponsors and Collaborators
Advantagene, Inc.
  More Information

Responsible Party: Advantagene, Inc.
ClinicalTrials.gov Identifier: NCT01436968     History of Changes
Other Study ID Numbers: PrTK03
First Submitted: September 19, 2011
First Posted: September 20, 2011
Last Update Posted: October 6, 2017
Last Verified: October 2017

Keywords provided by Advantagene, Inc.:
immunotherapy, cytotoxicity, tumor vaccine, prostate cancer, radiotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents