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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aglatimagene besadenovec + valacyclovir
Placebo + valacyclovir
Sponsored by
Candel Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring immunotherapy, cytotoxicity, tumor vaccine, prostate cancer, radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Center for Cancer Care - Gilbert
  • Arizona Urology Specialists
  • Arizona Oncology Services Foundation
  • Arizona Center for Cancer Care - Peoria
  • Arizona Center for Cancer Care - Deer Valley
  • Arizona Center for Cancer Care - Osborne
  • Arizona Center for Cancer Care - Shea
  • Arizona Center for Cancer Care - Surprise
  • Southern Arizona VA Health Care System
  • VA Northern California Health Care System
  • Precision Radiation Oncology
  • Valley View Hospital
  • Colorado Clinical Research
  • Advanced Urology
  • Sibley Memorial Hospital
  • 21st Century Oncology
  • 21st Century Oncology
  • 21st Century Oncology
  • 21st Century Oncology
  • Clinical Research Center of Florida
  • James A. Haley Veteran's Hospital
  • Florida Urology Partners
  • Jesse Brown VA Medical Center
  • The University of Chicago
  • Silver Cross Hospital
  • Southeast Louisiana Veterans Health Care System
  • VA Maryland Health Care System
  • Chesapeake Urology Research Associates
  • The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center
  • Walter Reed National Military Medical Center
  • University of Massachusetts Medical School
  • Kansas City VA Medical Center
  • Adult & Pediatric Urology, P.C.
  • Sheldon Freedman MD, Ltd.
  • VA Sierra Nevada Health Care System
  • New Jersey Urology - Cherry Hill
  • New Jersey Urology - Englewood
  • New Jersey Urology - Milburn
  • New Jersey Urology - Saddle Brook
  • New Jersey Urology - West Orange
  • New Mexico Oncology Hematology Consultants (NMOHC)
  • University of New Mexico Cancer Center
  • James J. Peters VA Medical Center
  • Advanced Radiation Centers of New York (Integrated Medical Professionals)
  • Associated Medical Professionals of NY, PLLC
  • Durham VA Health Care System
  • Cincinnati VA Medical Center
  • VA Portland Health Care System
  • Oregon Urology Institute
  • MidLantic Urology
  • Fox Chase Cancer Center
  • Ralph H. Johnson Veterans Affairs Medical Center
  • Carolina Urologic Research Center, LLC
  • Urology Austin
  • Austin Urology Institute
  • Austin Urology Institute - Northwest Austin Cancer Center
  • VA North Texas Health Care System
  • Urology Clinics of North Texas
  • Dr. Irving Fishman's Office
  • Houston Willowbrook Radiation Oncology
  • Dr. Ned Stein's Office
  • South Texas San Antonio VA Healthcare System
  • The University of Texas Health Science Center at San Antonio
  • Texas Urology Specialists-The Woodlands
  • The Methodist Hospital - The Woodlands
  • Texas Urology Specialists
  • Potomac Urology Center
  • Hunter Holmes McGuire VA Medical Center
  • Salem VA Medical Center
  • Urology of Virginia, PLLC
  • MultiCare Regional Cancer Center - Gig Harbor
  • MultiCare Regional Cancer Center - Tacoma
  • VA Caribbean Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ProstAtak®

Control

Arm Description

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

Placebo + valacyclovir + radiation therapy +/- ADT

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 19, 2011
Last Updated
May 9, 2023
Sponsor
Candel Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01436968
Brief Title
Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
Acronym
PrTK03
Official Title
A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Candel Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
immunotherapy, cytotoxicity, tumor vaccine, prostate cancer, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
711 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ProstAtak®
Arm Type
Experimental
Arm Description
Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo + valacyclovir + radiation therapy +/- ADT
Intervention Type
Biological
Intervention Name(s)
Aglatimagene besadenovec + valacyclovir
Other Intervention Name(s)
AdV-tk, CAN-2409
Intervention Description
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: 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.
Intervention Type
Biological
Intervention Name(s)
Placebo + valacyclovir
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Arizona Center for Cancer Care - Gilbert
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Arizona Urology Specialists
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Arizona Oncology Services Foundation
City
Multiple Locations
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Arizona Center for Cancer Care - Peoria
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Arizona Center for Cancer Care - Deer Valley
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Arizona Center for Cancer Care - Osborne
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Arizona Center for Cancer Care - Shea
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Arizona Center for Cancer Care - Surprise
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85374
Country
United States
Facility Name
Southern Arizona VA Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
VA Northern California Health Care System
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Facility Name
Precision Radiation Oncology
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Valley View Hospital
City
Glenwood Springs
State/Province
Colorado
ZIP/Postal Code
81601
Country
United States
Facility Name
Colorado Clinical Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Advanced Urology
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
21st Century Oncology
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
21st Century Oncology
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34202
Country
United States
Facility Name
21st Century Oncology
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
21st Century Oncology
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Clinical Research Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
James A. Haley Veteran's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Florida Urology Partners
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Jesse Brown VA Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Silver Cross Hospital
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Facility Name
Southeast Louisiana Veterans Health Care System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
VA Maryland Health Care System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Kansas City VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Adult & Pediatric Urology, P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Sheldon Freedman MD, Ltd.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
VA Sierra Nevada Health Care System
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
New Jersey Urology - Cherry Hill
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
New Jersey Urology - Englewood
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
New Jersey Urology - Milburn
City
Millburn
State/Province
New Jersey
ZIP/Postal Code
07041
Country
United States
Facility Name
New Jersey Urology - Saddle Brook
City
Saddle Brook
State/Province
New Jersey
ZIP/Postal Code
07663
Country
United States
Facility Name
New Jersey Urology - West Orange
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
New Mexico Oncology Hematology Consultants (NMOHC)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
James J. Peters VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Advanced Radiation Centers of New York (Integrated Medical Professionals)
City
North Hills
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Associated Medical Professionals of NY, PLLC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Durham VA Health Care System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Oregon Urology Institute
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
MidLantic Urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Ralph H. Johnson Veterans Affairs Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Carolina Urologic Research Center, LLC
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Urology Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Austin Urology Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Austin Urology Institute - Northwest Austin Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
VA North Texas Health Care System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Dr. Irving Fishman's Office
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Willowbrook Radiation Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Dr. Ned Stein's Office
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
South Texas San Antonio VA Healthcare System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4404
Country
United States
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Urology Specialists-The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77385
Country
United States
Facility Name
The Methodist Hospital - The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77385
Country
United States
Facility Name
Texas Urology Specialists
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Potomac Urology Center
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22311
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Salem VA Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Urology of Virginia, PLLC
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
MultiCare Regional Cancer Center - Gig Harbor
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98335
Country
United States
Facility Name
MultiCare Regional Cancer Center - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
VA Caribbean Healthcare System
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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