Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) for newly diagnosed localized prostate cancer
Abstract
5000
Background:
Standard of care (SoC) for intermediate to high-risk localized prostate cancer (PrCa) includes surgery or external beam radiation (EBRT) +/- androgen deprivation therapy (ADT). Nearly 30% of men undergoing EBRT will experience recurrence requiring ADT and salvage therapies that negatively impact quality of life. CAN-2409 is a replication-defective adenovirus encoding the HSV-tk gene that, when combined with valacyclovir (prodrug), results in immunogenic cell death. This results in immunization against tumor antigens and long-term tumor control.
Methods:
We conducted a phase 3, multicenter, double-blinded, randomized, placebo (PBO)-controlled clinical trial in PrCa patients (pts) planning to receive EBRT+/- short course ADT (<6 mos); NCT01436968. 745 pts were randomized 2:1 (496 in CAN-2409+prodrug and 249 in PBO+prodrug) and stratified by NCCN risk group and ADT use. Three intraprostatic injections of CAN-2409 (5x10
11
v/2mL) or PBO were administered, each followed by 14 days of prodrug. Follow-up included a prostate biopsy 2 years after EBRT. Primary endpoint was disease-free survival (DFS), defined as time from randomization to PrCa recurrence (local/regional failure or distant metastasis) or death in the intent-to-treat population. Median follow up time was 50.3 mos. The study was conducted under a special protocol assessment (SPA) granted by the FDA.
Results:
Treatment with CAN-2409 reduced the risk of PrCa recurrence or death by 30% (median DFS not…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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