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

Prostate Cancer Clinical Trial

— PrTK03  

Official title:

A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01436968
• Other study ID #: PrTK03
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 2011
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Candel Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 711
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Aglatimagene besadenovec + valacyclovir
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.
• 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.

Locations

Country	Name	City	State
Puerto Rico	VA Caribbean Healthcare System	San Juan
United States	New Mexico Oncology Hematology Consultants (NMOHC)	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Potomac Urology Center	Alexandria	Virginia
United States	Austin Urology Institute	Austin	Texas
United States	Austin Urology Institute - Northwest Austin Cancer Center	Austin	Texas
United States	Urology Austin	Austin	Texas
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Chesapeake Urology Research Associates	Baltimore	Maryland
United States	The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	VA Maryland Health Care System	Baltimore	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	James J. Peters VA Medical Center	Bronx	New York
United States	Ralph H. Johnson Veterans Affairs Medical Center	Charleston	South Carolina
United States	New Jersey Urology - Cherry Hill	Cherry Hill	New Jersey
United States	Jesse Brown VA Medical Center	Chicago	Illinois
United States	The University of Chicago	Chicago	Illinois
United States	Cincinnati VA Medical Center	Cincinnati	Ohio
United States	Urology Clinics of North Texas	Dallas	Texas
United States	VA North Texas Health Care System	Dallas	Texas
United States	Durham VA Health Care System	Durham	North Carolina
United States	New Jersey Urology - Englewood	Englewood	New Jersey
United States	21st Century Oncology	Fort Lauderdale	Florida
United States	MultiCare Regional Cancer Center - Gig Harbor	Gig Harbor	Washington
United States	Arizona Center for Cancer Care - Gilbert	Gilbert	Arizona
United States	Arizona Urology Specialists	Glendale	Arizona
United States	Valley View Hospital	Glenwood Springs	Colorado
United States	Dr. Irving Fishman's Office	Houston	Texas
United States	Dr. Ned Stein's Office	Houston	Texas
United States	Houston Willowbrook Radiation Oncology	Houston	Texas
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	Colorado Clinical Research	Lakewood	Colorado
United States	21st Century Oncology	Lakewood Ranch	Florida
United States	Sheldon Freedman MD, Ltd.	Las Vegas	Nevada
United States	VA Northern California Health Care System	Mather	California
United States	New Jersey Urology - Milburn	Millburn	New Jersey
United States	Arizona Oncology Services Foundation	Multiple Locations	Arizona
United States	Carolina Urologic Research Center, LLC	Myrtle Beach	South Carolina
United States	21st Century Oncology	Naples	Florida
United States	Silver Cross Hospital	New Lenox	Illinois
United States	Southeast Louisiana Veterans Health Care System	New Orleans	Louisiana
United States	Advanced Radiation Centers of New York (Integrated Medical Professionals)	North Hills	New York
United States	Adult & Pediatric Urology, P.C.	Omaha	Nebraska
United States	Advanced Urology	Parker	Colorado
United States	Arizona Center for Cancer Care - Peoria	Peoria	Arizona
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Arizona Center for Cancer Care - Deer Valley	Phoenix	Arizona
United States	21st Century Oncology	Plantation	Florida
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	VA Portland Health Care System	Portland	Oregon
United States	VA Sierra Nevada Health Care System	Reno	Nevada
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	New Jersey Urology - Saddle Brook	Saddle Brook	New Jersey
United States	Salem VA Medical Center	Salem	Virginia
United States	South Texas San Antonio VA Healthcare System	San Antonio	Texas
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Arizona Center for Cancer Care - Osborne	Scottsdale	Arizona
United States	Arizona Center for Cancer Care - Shea	Scottsdale	Arizona
United States	Oregon Urology Institute	Springfield	Oregon
United States	Arizona Center for Cancer Care - Surprise	Surprise	Arizona
United States	Associated Medical Professionals of NY, PLLC	Syracuse	New York
United States	MultiCare Regional Cancer Center - Tacoma	Tacoma	Washington
United States	Florida Urology Partners	Tampa	Florida
United States	James A. Haley Veteran's Hospital	Tampa	Florida
United States	Texas Urology Specialists-The Woodlands	The Woodlands	Texas
United States	The Methodist Hospital - The Woodlands	The Woodlands	Texas
United States	Texas Urology Specialists	Tomball	Texas
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	Precision Radiation Oncology	Tustin	California
United States	Urology of Virginia, PLLC	Virginia Beach	Virginia
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	New Jersey Urology - West Orange	West Orange	New Jersey
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Candel Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	PSA nadir will be compared for the ProstAtak® arm versus the placebo control arm.		Assessed at each visit every 6 months through year 5.
Secondary	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.
Secondary	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.