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

NCT01436968 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: PrTK03
• Study Type: interventional
• Target: 711
• Locations: 2 countries
• Sites: 73

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.

Conditions

Prostate Cancer

Keywords

immunotherapy, cytotoxicity, tumor vaccine, prostate cancer, radiotherapy

Outcome Measures

Primary Outcomes (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.

  Assessed at each visit every 6 months through year 5 until event occurs.

Secondary Outcomes (4)

• Prostate cancer specific survival and overall survival will be compared for the ProstAtak® arm versus the placebo control arm.

  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.

  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.

  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.

  Assessed at each visit and continuously throughout the study.

Study Arms (2)

ProstAtak®

EXPERIMENTAL

Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT

Biological: Aglatimagene besadenovec + valacyclovir

Control

PLACEBO COMPARATOR

Placebo + valacyclovir + radiation therapy +/- ADT

Biological: Placebo + valacyclovir

Interventions

Aglatimagene besadenovec + valacyclovir BIOLOGICAL

Patients will receive three courses of ProstAtak® each consisting of aglatimagene besadenovec 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.

Also known as: AdV-tk, CAN-2409

ProstAtak®

Placebo + valacyclovir BIOLOGICAL

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Candel Therapeutics, Inc.: lead

Study Sites (73)

Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, 85297, United States

Location

Arizona Urology Specialists

Glendale, Arizona, 85308, United States

Location

Arizona Oncology Services Foundation

Multiple Locations, Arizona, 85260, United States

Location

Arizona Center for Cancer Care - Peoria

Peoria, Arizona, 85381, United States

Location

Arizona Center for Cancer Care - Deer Valley

Phoenix, Arizona, 85027, United States

Location

Arizona Center for Cancer Care - Osborne

Scottsdale, Arizona, 85251, United States

Location

Arizona Center for Cancer Care - Shea

Scottsdale, Arizona, 85258, United States

Location

Arizona Center for Cancer Care - Surprise

Surprise, Arizona, 85374, United States

Location

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

VA Northern California Health Care System

Mather, California, 95655, United States

Location

Precision Radiation Oncology

Tustin, California, 92780, United States

Location

Valley View Hospital

Glenwood Springs, Colorado, 81601, United States

Location

Colorado Clinical Research

Lakewood, Colorado, 80228, United States

Location

Advanced Urology

Parker, Colorado, 80134, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

21st Century Oncology

Fort Lauderdale, Florida, 33324, United States

Location

21st Century Oncology

Lakewood Rch, Florida, 34202, United States

Location

21st Century Oncology

Naples, Florida, 34102, United States

Location

21st Century Oncology

Plantation, Florida, 33324, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

James A. Haley Veteran's Hospital

Tampa, Florida, 33612, United States

Location

Florida Urology Partners

Tampa, Florida, 33615, United States

Location

Jesse Brown VA Medical Center

Chicago, Illinois, 60612, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Silver Cross Hospital

New Lenox, Illinois, 60451, United States

Location

Southeast Louisiana Veterans Health Care System

New Orleans, Louisiana, 70119, United States

Location

VA Maryland Health Care System

Baltimore, Maryland, 21201, United States

Location

Chesapeake Urology Research Associates

Baltimore, Maryland, 21204, United States

Location

The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Adult & Pediatric Urology, P.C.

Omaha, Nebraska, 68114, United States

Location

Sheldon Freedman MD, Ltd.

Las Vegas, Nevada, 89144, United States

Location

VA Sierra Nevada Health Care System

Reno, Nevada, 89502, United States

Location

New Jersey Urology - Cherry Hill

Cherry Hill, New Jersey, 08003, United States

Location

New Jersey Urology - Englewood

Englewood, New Jersey, 07631, United States

Location

New Jersey Urology - Milburn

Millburn, New Jersey, 07041, United States

Location

New Jersey Urology - Saddle Brook

Saddle Brook, New Jersey, 07663, United States

Location

New Jersey Urology - West Orange

West Orange, New Jersey, 07052, United States

Location

New Mexico Oncology Hematology Consultants (NMOHC)

Albuquerque, New Mexico, 87109, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Advanced Radiation Centers of New York (Integrated Medical Professionals)

North Hills, New York, 11042, United States

Location

Associated Medical Professionals of NY, PLLC

Syracuse, New York, 13210, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

Durham VA Health Care System

Durham, North Carolina, 27705, United States

Location

Cincinnati VA Medical Center

Cincinnati, Ohio, 45220, United States

Location

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

Oregon Urology Institute

Springfield, Oregon, 97477, United States

Location

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Ralph H. Johnson Veterans Affairs Medical Center

Charleston, South Carolina, 29401, United States

Location

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

Location

Urology Austin

Austin, Texas, 78705, United States

Location

Austin Urology Institute

Austin, Texas, 78758, United States

Location

Austin Urology Institute - Northwest Austin Cancer Center

Austin, Texas, 78759, United States

Location

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Dr. Irving Fishman's Office

Houston, Texas, 77030, United States

Location

Houston Willowbrook Radiation Oncology

Houston, Texas, 77070, United States

Location

Dr. Ned Stein's Office

Houston, Texas, 77074, United States

Location

South Texas San Antonio VA Healthcare System

San Antonio, Texas, 78229-4404, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Texas Urology Specialists-The Woodlands

The Woodlands, Texas, 77385, United States

Location

The Methodist Hospital - The Woodlands

The Woodlands, Texas, 77385, United States

Location

Texas Urology Specialists

Tomball, Texas, 77375, United States

Location

Potomac Urology Center

Alexandria, Virginia, 22311, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Salem VA Medical Center

Salem, Virginia, 24153, United States

Location

Urology of Virginia, PLLC

Virginia Beach, Virginia, 23462, United States

Location

MultiCare Regional Cancer Center - Gig Harbor

Gig Harbor, Washington, 98335, United States

Location

MultiCare Regional Cancer Center - Tacoma

Tacoma, Washington, 98405, United States

Location

VA Caribbean Healthcare System

San Juan, 00921, Puerto Rico

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 20, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2024
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

PR (1); US (72)