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

Sponsor

Candel Therapeutics, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01436968

Collaborator

(none)

711

Enrollment

Locations

Arms

9.7

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Biological: Aglatimagene besadenovec + valacyclovir Biological: Placebo + valacyclovir	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

711 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (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

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ProstAtak® Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT	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. Other Names: AdV-tk CAN-2409
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.

Arm

Intervention/Treatment

Experimental: ProstAtak®

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

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.

Other Names:

AdV-tk

CAN-2409

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.

Outcome Measures

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. [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. [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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Center for Cancer Care - Gilbert	Gilbert	Arizona	United States	85297
2	Arizona Urology Specialists	Glendale	Arizona	United States	85308
3	Arizona Oncology Services Foundation	Multiple Locations	Arizona	United States	85260
4	Arizona Center for Cancer Care - Peoria	Peoria	Arizona	United States	85381
5	Arizona Center for Cancer Care - Deer Valley	Phoenix	Arizona	United States	85027
6	Arizona Center for Cancer Care - Osborne	Scottsdale	Arizona	United States	85251
7	Arizona Center for Cancer Care - Shea	Scottsdale	Arizona	United States	85258
8	Arizona Center for Cancer Care - Surprise	Surprise	Arizona	United States	85374
9	Southern Arizona VA Health Care System	Tucson	Arizona	United States	85723
10	VA Northern California Health Care System	Mather	California	United States	95655
11	Precision Radiation Oncology	Tustin	California	United States	92780
12	Valley View Hospital	Glenwood Springs	Colorado	United States	81601
13	Colorado Clinical Research	Lakewood	Colorado	United States	80228
14	Advanced Urology	Parker	Colorado	United States	80134
15	Sibley Memorial Hospital	Washington	District of Columbia	United States	20016
16	21st Century Oncology	Fort Lauderdale	Florida	United States	33324
17	21st Century Oncology	Lakewood Ranch	Florida	United States	34202
18	21st Century Oncology	Naples	Florida	United States	34102
19	21st Century Oncology	Plantation	Florida	United States	33324
20	Clinical Research Center of Florida	Pompano Beach	Florida	United States	33060
21	James A. Haley Veteran's Hospital	Tampa	Florida	United States	33612
22	Florida Urology Partners	Tampa	Florida	United States	33615
23	Jesse Brown VA Medical Center	Chicago	Illinois	United States	60612
24	The University of Chicago	Chicago	Illinois	United States	60637
25	Silver Cross Hospital	New Lenox	Illinois	United States	60451
26	Southeast Louisiana Veterans Health Care System	New Orleans	Louisiana	United States	70119
27	VA Maryland Health Care System	Baltimore	Maryland	United States	21201
28	Chesapeake Urology Research Associates	Baltimore	Maryland	United States	21204
29	The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland	United States	21231
30	Walter Reed National Military Medical Center	Bethesda	Maryland	United States	20889
31	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01605
32	Kansas City VA Medical Center	Kansas City	Missouri	United States	64128
33	Adult & Pediatric Urology, P.C.	Omaha	Nebraska	United States	68114
34	Sheldon Freedman MD, Ltd.	Las Vegas	Nevada	United States	89144
35	VA Sierra Nevada Health Care System	Reno	Nevada	United States	89502
36	New Jersey Urology - Cherry Hill	Cherry Hill	New Jersey	United States	08003
37	New Jersey Urology - Englewood	Englewood	New Jersey	United States	07631
38	New Jersey Urology - Milburn	Millburn	New Jersey	United States	07041
39	New Jersey Urology - Saddle Brook	Saddle Brook	New Jersey	United States	07663
40	New Jersey Urology - West Orange	West Orange	New Jersey	United States	07052
41	New Mexico Oncology Hematology Consultants (NMOHC)	Albuquerque	New Mexico	United States	87109
42	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131
43	James J. Peters VA Medical Center	Bronx	New York	United States	10468
44	Advanced Radiation Centers of New York (Integrated Medical Professionals)	North Hills	New York	United States	11042
45	Associated Medical Professionals of NY, PLLC	Syracuse	New York	United States	13210
46	Durham VA Health Care System	Durham	North Carolina	United States	27705
47	Cincinnati VA Medical Center	Cincinnati	Ohio	United States	45220
48	VA Portland Health Care System	Portland	Oregon	United States	97239
49	Oregon Urology Institute	Springfield	Oregon	United States	97477
50	MidLantic Urology	Bala-Cynwyd	Pennsylvania	United States	19004
51	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111-2497
52	Ralph H. Johnson Veterans Affairs Medical Center	Charleston	South Carolina	United States	29401
53	Carolina Urologic Research Center, LLC	Myrtle Beach	South Carolina	United States	29572
54	Urology Austin	Austin	Texas	United States	78705
55	Austin Urology Institute	Austin	Texas	United States	78758
56	Austin Urology Institute - Northwest Austin Cancer Center	Austin	Texas	United States	78759
57	VA North Texas Health Care System	Dallas	Texas	United States	75216
58	Urology Clinics of North Texas	Dallas	Texas	United States	75231
59	Dr. Irving Fishman's Office	Houston	Texas	United States	77030
60	Houston Willowbrook Radiation Oncology	Houston	Texas	United States	77070
61	Dr. Ned Stein's Office	Houston	Texas	United States	77074
62	South Texas San Antonio VA Healthcare System	San Antonio	Texas	United States	78229-4404
63	The University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229
64	Texas Urology Specialists-The Woodlands	The Woodlands	Texas	United States	77385
65	The Methodist Hospital - The Woodlands	The Woodlands	Texas	United States	77385
66	Texas Urology Specialists	Tomball	Texas	United States	77375
67	Potomac Urology Center	Alexandria	Virginia	United States	22311
68	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia	United States	23249
69	Salem VA Medical Center	Salem	Virginia	United States	24153
70	Urology of Virginia, PLLC	Virginia Beach	Virginia	United States	23462
71	MultiCare Regional Cancer Center - Gig Harbor	Gig Harbor	Washington	United States	98335
72	MultiCare Regional Cancer Center - Tacoma	Tacoma	Washington	United States	98405
73	VA Caribbean Healthcare System	San Juan		Puerto Rico	00921

Sponsors and Collaborators

Candel Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Candel Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT01436968

Other Study ID Numbers:

PrTK03

First Posted:

Sep 20, 2011

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Keywords provided by Candel Therapeutics, Inc.

immunotherapy, cytotoxicity, tumor vaccine, prostate cancer, radiotherapy

Additional relevant MeSH terms:

Prostatic Neoplasms

Valacyclovir

Study Results

No Results Posted as of Aug 10, 2022