Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Biological: Aglatimagene besadenovec + valacyclovirBiological: Placebo + valacyclovir
- Registration Number
- NCT01436968
- Lead Sponsor
- Candel Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 711
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ProstAtak® Aglatimagene besadenovec + valacyclovir Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT Control Placebo + valacyclovir Placebo + valacyclovir + radiation therapy +/- ADT
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (70)
Arizona Center for Cancer Care - Gilbert
🇺🇸Gilbert, Arizona, United States
Arizona Urology Specialists
🇺🇸Glendale, Arizona, United States
Arizona Oncology Services Foundation
🇺🇸Multiple Locations, Arizona, United States
Arizona Center for Cancer Care - Peoria
🇺🇸Peoria, Arizona, United States
Arizona Center for Cancer Care - Deer Valley
🇺🇸Phoenix, Arizona, United States
Arizona Center for Cancer Care - Osborne
🇺🇸Scottsdale, Arizona, United States
Arizona Center for Cancer Care - Shea
🇺🇸Scottsdale, Arizona, United States
Arizona Center for Cancer Care - Surprise
🇺🇸Surprise, Arizona, United States
Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States
VA Northern California Health Care System
🇺🇸Mather, California, United States
Scroll for more (60 remaining)Arizona Center for Cancer Care - Gilbert🇺🇸Gilbert, Arizona, United States