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NCT01436968 (CAN2409 in localized prostate cancer): BVCT ex-ante prediction vs. reported outcome

On 6 Aug 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 11 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet weak (borderline for DFS) and commercially insufficient (for OS).

Clinical Trial

NCTID
NCT01436968
Acronym
PrTK03
Drug Name
CAN2409
Drug MoA
AAV-mediated intratumoral delivery of HSV-TK as an oncolytic viral therapy
Drug Modality
oncolytic viral gene therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
localized prostate cancer
Human Patients
711
Sponsor
Candel Therapeutics
Phase
Phase 3

Prediction of , index 421

Prospective Prediction
Prediction Index
421
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit in DFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
127 days in advance
Readout Data Interpretation
CAN2409 + RT achieved statistically significant 14.5% relative improvement in DFS at month 54 (not the prespecified month 60) over RT alone (p=0.0155); CAN2409 + RT probably failed to achieve statistical significance in OS improvement (no mentioning of OS data in the topline readout)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet weak (borderline for DFS) and commercially insufficient (for OS)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer
Phase
Phase 3
Status
Active not recruiting
Enrollment
711
Lead sponsor
Candel Therapeutics, Inc.
Conditions
Prostate Cancer
Interventions
BIOLOGICAL: Aglatimagene besadenovec + valacyclovir; BIOLOGICAL: Placebo + valacyclovir
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2011-09
Primary completion
2024-08
Completion
2030-12
Primary outcomes
  • 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.)

NCT01436968 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials