Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
711estimated
Sites
73
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Sep 2011 | not stated | When the study began enrolling |
| Primary completion | Aug 2024 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2011-09-20 | estimated | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-07-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Prostate Cancer
Interventions
- Biological: Aglatimagene besadenovec + valacyclovir — also filed as AdV-tk, CAN-2409
- Biological: Placebo + valacyclovir
Primary outcome
what the primary-completion date above is the date OFDisease 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.
measured Assessed at each visit every 6 months through year 5 until event occurs.
Publications
- PMID 42225101 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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