Clinical trial NCT01436968: Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
Official title: A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: immunotherapy, cytotoxicity, tumor vaccine, prostate cancer, radiotherapy
Lead sponsor: Candel Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-20
Enrollment: 711
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Assessed at each visit every 6 months through year 5 until event occurs.
Secondary outcomes:
measure: Prostate cancer specific survival and overall survival will be compared for the ProstAtak® arm versus the placebo control arm.
timeFrame: Assessed at each visit every 6 months through year 5 after which long-term follow up of general health status will continue yearly.
measure: PSA nadir will be compared for the ProstAtak® arm versus the placebo control arm.
timeFrame: Assessed at each visit every 6 months through year 5.
measure: 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.
timeFrame: Assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation.
measure: 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.
timeFrame: Assessed at each visit and continuously throughout the study.
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Arizona Center for Cancer Care - Gilbert
state: Arizona
city: Glendale
country: United States
facility: Arizona Urology Specialists
state: Arizona
city: Multiple Locations
country: United States
facility: Arizona Oncology Services Foundation
state: Arizona
city: Peoria
country: United States
facility: Arizona Center for Cancer Care - Peoria
state: Arizona
city: Phoenix
country: United States
facility: Arizona Center for Cancer Care - Deer Valley
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Center for Cancer Care - Osborne
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Center for Cancer Care - Shea
state: Arizona
city: Surprise
country: United States
facility: Arizona Center for Cancer Care - Surprise
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Mather
country: United States
facility: VA Northern California Health Care System
state: California
city: Tustin
country: United States
facility: Precision Radiation Oncology
state: California
city: Glenwood Springs
country: United States
facility: Valley View Hospital
state: Colorado
city: Lakewood
country: United States
facility: Colorado Clinical Research
state: Colorado
city: Parker
country: United States
facility: Advanced Urology
state: Colorado
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: 21st Century Oncology
state: Florida
city: Lakewood Ranch
country: United States
facility: 21st Century Oncology
state: Florida
city: Naples
country: United States
facility: 21st Century Oncology
state: Florida
city: Plantation
country: United States
facility: 21st Century Oncology
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Tampa
country: United States
facility: James A. Haley Veteran's Hospital
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: New Lenox
country: United States
facility: Silver Cross Hospital
state: Illinois
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System
state: Louisiana
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
city: Baltimore
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Baltimore
country: United States
facility: The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Omaha
country: United States
facility: Adult & Pediatric Urology, P.C.
state: Nebraska
city: Las Vegas
country: United States
facility: Sheldon Freedman MD, Ltd.
state: Nevada
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
city: Cherry Hill
country: United States
facility: New Jersey Urology - Cherry Hill
state: New Jersey
city: Englewood
country: United States
facility: New Jersey Urology - Englewood
state: New Jersey
city: Millburn
country: United States
facility: New Jersey Urology - Milburn
state: New Jersey
city: Saddle Brook
country: United States
facility: New Jersey Urology - Saddle Brook
state: New Jersey
city: West Orange
country: United States
facility: New Jersey Urology - West Orange
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants (NMOHC)
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
city: North Hills
country: United States
facility: Advanced Radiation Centers of New York (Integrated Medical Professionals)
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY, PLLC
state: New York
city: Durham
country: United States
facility: Durham VA Health Care System
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Ralph H. Johnson Veterans Affairs Medical Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center, LLC
state: South Carolina
city: Austin
country: United States
facility: Urology Austin
state: Texas
city: Austin
country: United States
facility: Austin Urology Institute
state: Texas
city: Austin
country: United States
facility: Austin Urology Institute - Northwest Austin Cancer Center
state: Texas
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Houston
country: United States
facility: Dr. Irving Fishman's Office
state: Texas
city: Houston
country: United States
facility: Houston Willowbrook Radiation Oncology
state: Texas
city: Houston
country: United States
facility: Dr. Ned Stein's Office
state: Texas
city: San Antonio
country: United States
facility: South Texas San Antonio VA Healthcare System
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: The Woodlands
country: United States
facility: Texas Urology Specialists-The Woodlands
state: Texas
city: The Woodlands
country: United States
facility: The Methodist Hospital - The Woodlands
state: Texas
city: Tomball
country: United States
facility: Texas Urology Specialists
state: Texas
city: Alexandria
country: United States
facility: Potomac Urology Center
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
city: Salem
country: United States
facility: Salem VA Medical Center
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
city: Gig Harbor
country: United States
facility: MultiCare Regional Cancer Center - Gig Harbor
state: Washington
city: Tacoma
country: United States
facility: MultiCare Regional Cancer Center - Tacoma
state: Washington
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System
Study officials:
References: