Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer - Full Text View

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: 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:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Prostate Cancer

Drug Information available for: Valacyclovir Valacyclovir hydrochloride

U.S. FDA Resources

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: The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. The second injection will be 0-3 days before initiation of radiation therapy. 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: The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. The second injection will be 0-3 days before initiation of radiation therapy. 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.

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:

The first injection will be given at least 15 days and not more than 8 weeks before starting radiation.
The second injection will be 0-3 days before initiation of radiation therapy.
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:

The first injection will be given at least 15 days and not more than 8 weeks before starting radiation.
The second injection will be 0-3 days before initiation of radiation therapy.
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 (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

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	Active, not recruiting
Multiple Locations, Arizona, United States, 85260
United States, Colorado
Genitourinary Surgical Consultants	Active, not recruiting
Denver, Colorado, United States, 80220
Foothills Urology	Active, not recruiting
Golden, Colorado, United States, 80401
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, Pennsylvania
Fox Chase Cancer Center	Active, not recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
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
Study First Received:	September 19, 2011
Last Updated:	May 9, 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

ClinicalTrials.gov processed this record on June 23, 2017

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