Phase 3 Study of ProstAtak™ Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer (PrTK03)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified July 2016 by Advantagene, Inc.
Sponsor:
Advantagene, Inc.
Information provided by (Responsible Party):
Advantagene, Inc.
ClinicalTrials.gov Identifier:
NCT01436968
First received: September 19, 2011
Last updated: July 29, 2016
Last verified: July 2016
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: ProstAtak™(AdV-tk) + valacyclovir Biological: Placebo + valacyclovir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Advantagene, Inc.:
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. [ Time Frame: Assessed at each visit every 6 months through year 5 until event occurs. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 711 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | December 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ProstAtak™
ProstAtak™(AdV-tk) + valacyclovir + radiation therapy +/- ADT
|
Biological: ProstAtak™(AdV-tk) + valacyclovir
Patients will receive three courses of ProstAtak™ each consisting of AdV-tk injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows:
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 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 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. |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436968
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436968
Locations
| United States, Arizona | |
| Arizona Oncology Services Foundation | Active, not recruiting |
| Phoenix, Mesa, Scottsdale, Sedona, Arizona, United States, 85260 | |
| United States, Colorado | |
| Genitourinary Surgical Consultants | Recruiting |
| Denver, Colorado, United States, 80220 | |
| Contact: Jessica Basefsky 303-320-0120 jessica.basefsky@gmail.com | |
| Sub-Investigator: Jeffrey Snyder, MD | |
| Foothills Urology | Recruiting |
| Golden, Colorado, United States, 80401 | |
| Contact: Dani Puga 303-985-2550 dani@foothillsurologypc.com | |
| Sub-Investigator: David Cahn, MD | |
| Advanced Urology | Recruiting |
| Parker, Colorado, United States, 80134 | |
| Contact: Damian Sorce, MD 720-457-8362 | |
| Principal Investigator: Damian Sorce, MD | |
| United States, Maryland | |
| The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center | Recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Contact: Kristi Purcell, RN 410-502-9242 kpurcel2@jhmi.edu | |
| Contact: Megan Kummerlowe 410-502-2971 mkummer1@jhmi.edu | |
| Principal Investigator: Theodore DeWeese, MD | |
| Walter Reed National Military Medical Center | Recruiting |
| Bethesda, Maryland, United States, 20889 | |
| Contact: Judith A. Travis, RN, CCRC 301-319-2927 judith.a.travis.ctr@mail.mil | |
| Principal Investigator: Inger L. Rosner, MD, MC | |
| United States, Massachusetts | |
| University of Massachusetts Medical School | Recruiting |
| Worcester, Massachusetts, United States, 01605 | |
| Contact: Margaret R Humphries, RN, CCRC 508-856-5711 Margaret.Humphries@umassmed.edu | |
| Principal Investigator: Mitchell H. Sokoloff, MD | |
| United States, New Mexico | |
| New Mexico Oncology Hematology Consultants (NMOHC) | Recruiting |
| Albuquerque, New Mexico, United States, 87109 | |
| Contact: Andrea Yost 505-243-4039 research@nmohc.com | |
| Principal Investigator: Gregg Franklin, MD, PhD | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Mark Fischer 505-925-7487 mjfischer@salud.unm.edu | |
| Contact: Susan Lopez 505-925-0375 slopez@salud.unm.edu | |
| Principal Investigator: Thomas M. Schroeder, MD | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Michael J. Zelefsky, MD 212-639-6802 | |
| Principal Investigator: Michael J. Zelefsky, MD | |
| Advanced Radiation Centers of New York (Integrated Medical Professionals) | Recruiting |
| North Hills, New York, United States, 11042 | |
| Contact: Michelle Primiano 516-394-9600 mprimiano@imppllc.com | |
| Contact: Teri Alaimo 631-804-2516 talaimo@imppllc.com | |
| Principal Investigator: Shawn H. Zimberg, MD | |
| Principal Investigator: Carl A. Olsson, MD | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Contact: Joan Leahy, RN, BSN 215-728-2994 Joan.Leahy@fccc.edu | |
| Contact: Michael M. Yurescko, RN, DC 215-728-3117 michael.yurescko@fccc.edu | |
| Principal Investigator: Eric Horwitz, MD | |
| United States, Texas | |
| Urology Clinics of North Texas | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Contact: Sharon Reeves, RN-BSN, CCRC 214-580-1391 reeves@urologyclinics.com | |
| Principal Investigator: James S. Cochran, MD | |
| Dr. Irving Fishman's Office | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Miriam Fishman 713-790-1800 miriamfishman@yahoo.com | |
| Sub-Investigator: Irving Fishman, MD | |
| Dr. Ned Stein's Office | Recruiting |
| Houston, Texas, United States, 77074 | |
| Contact: Ned Stein, MD 713-776-8888 | |
| Sub-Investigator: Ned Stein, MD | |
| Texas Urology Specialists | Recruiting |
| Tomball, Texas, United States, 77375 | |
| Contact: Beth Petrich 281-351-5174 beth.petrich@usoncology.com | |
| Principal Investigator: Steven W. Sukin, MD | |
Sponsors and Collaborators
Advantagene, Inc.
More Information
| Responsible Party: | Advantagene, Inc. |
| ClinicalTrials.gov Identifier: | NCT01436968 History of Changes |
| Other Study ID Numbers: | PrTK03 |
| Study First Received: | September 19, 2011 |
| Last Updated: | July 29, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Advantagene, Inc.:
|
immunotherapy, cytotoxicity, tumor vaccine, prostate cancer, radiotherapy |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 23, 2016