Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07332000 | A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec | PHASE2 | RECRUITING | 45 | — | — | Oct 30, 2025 | Aug 1, 2026 | Mar 20, 2026 | 7 | United States |
Evaluation of shedding of aglatimagene besadenovec viral genomes in urine, blood, and semen samples using validated bioassays over time.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Patients receiving aglatimagene besadenovec + valacyclovir along with External Beam Radiation Therapy (EBRT) |
| Control | ACTIVE_COMPARATOR | External Beam Radiation Therapy (EBRT) alone |
| Name | Type | Description |
|---|---|---|
| aglatimagene besadenovec + valacyclovir | BIOLOGICAL | aglatimagene besadenovec: a genetically modified replication-defective adenoviral vector expressing the herpes simplex virus (HSV) thymidine kinase (tk) gene. Patients in the treatment arm will receive 3 intraprostatic injections of aglatimagene besadenovec, with each injection followed by a 14-day course of valacyclovir. Patients will have aglatimagene besadenovec administered either transrectally or transperineally. |
| External Beam Radiation Therapy (EBRT) | RADIATION | Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT) |
Inclusion Criteria: 1. Participants must give study-specific informed consent prior to enrollment 2. Histologically confirmed adenocarcinoma of the prostate 3. Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria 4. Participants must be planning and medically...