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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Advantagene, Inc.
Sponsor:
Information provided by (Responsible Party):
Advantagene, Inc.
ClinicalTrials.gov Identifier:
NCT01436968
First received: September 19, 2011
Last updated: September 9, 2014
Last verified: September 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 711
Study Start Date: September 2011
Estimated Primary Completion Date: September 2017 (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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436968

Locations
United States, Arizona
Arizona Oncology Services Foundation Recruiting
Phoenix, Mesa, Scottsdale, Sedona, Arizona, United States, 85260
Contact: Terry Thomas    602-240-3383    tthomas@azoncology.com   
Contact: Penny Labriola    602-240-3377    plabriola@azoncology.com   
Principal Investigator: David Beyer, MD         
United States, Colorado
Genitourinary Surgical Consultants Recruiting
Denver, Colorado, United States, 80220
Contact: Jessica Basefsky    303-320-0120    jessica.basefsky@gmail.com   
Sub-Investigator: Jeffrey Snyder, MD         
Foothills Urology Recruiting
Golden, Colorado, United States, 80401
Contact: Dani Puga    303-985-2550    dani@foothillsurologypc.com   
Sub-Investigator: David Cahn, MD         
Advanced Urology Recruiting
Parker, Colorado, United States, 80134
Contact: Emily Jewett    720-457-8362    ejewett@advancedgu.com   
Principal Investigator: Damian Sorce, MD         
United States, Maryland
The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
Contact: Kelly Szajna, RN    410-502-9242    kszajna1@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: David G. McLeod, MD, MC (RET)         
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: Terence R. Flotte, MD         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Andrea Yost    505-925-0366    ayost@nmcca.org   
Contact: Valerie Parks    505-925-0390    VParks@salud.unm.edu   
Principal Investigator: Thomas M. Schroeder, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michael J. Zelefsky, MD    212-639-6802      
Principal Investigator: Michael J. Zelefsky, 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   
Contact: Teri Alaimo    631-804-2516    talaimo@imppllc.com   
Principal Investigator: Shawn H. Zimberg, MD         
Principal Investigator: Carl A. Olsson, MD         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Joan Leahy, RN, BSN    215-728-2994    Joan.Leahy@fccc.edu   
Contact: Michael M. Yurescko, RN, DC    215-728-3117    michael.yurescko@fccc.edu   
Principal Investigator: Eric Horwitz, MD         
United States, Texas
Urology Clinics of North Texas Recruiting
Dallas, Texas, United States, 75231
Contact: Sharon Reeves, RN-BSN, CCRC    214-580-1391    reeves@urologyclinics.com   
Contact: Eliza Carson    214-580-1482    carson@urologyclinics.com   
Principal Investigator: James S. Cochran, MD         
Dr. Irving Fishman's Office Recruiting
Houston, Texas, United States, 77030
Contact: Miriam Fishman    713-790-1800    miriamfishman@yahoo.com   
Sub-Investigator: Irving Fishman, MD         
Dr. Ned Stein's Office Recruiting
Houston, Texas, United States, 77074
Contact: Barbara Brown    713-776-8888    barbara@steinmd.com   
Sub-Investigator: Ned Stein, MD         
Texas Urology Specialists Recruiting
Tomball, Texas, United States, 77375
Contact: Beth Petrich    281-351-5174    beth.petrich@usoncology.com   
Contact: Teresa Toth    281-351-5174    teresa.toth@usoncology.com   
Principal Investigator: Steven W. Sukin, MD         
Sponsors and Collaborators
Advantagene, Inc.
  More Information

No publications provided

Responsible Party: Advantagene, Inc.
ClinicalTrials.gov Identifier: NCT01436968     History of Changes
Other Study ID Numbers: PrTK03
Study First Received: September 19, 2011
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

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
Prostatic Diseases
Genital Diseases, Male
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014