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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01436968 | Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 711 | — | — | Sep 1, 2011 | Dec 1, 2030 | Jul 30, 2025 | 73 | United States, Puerto Rico |
| NCT02768363 | Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES) | PHASE2 | ACTIVE NOT_RECRUITING | 187 | — | — | May 1, 2016 | Dec 1, 2026 | Jul 30, 2025 | 23 | United States, Mexico |
Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer
| Arm | Type | Description |
|---|---|---|
| ProstAtak® | EXPERIMENTAL | Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT |
| Control | PLACEBO_COMPARATOR | Placebo + valacyclovir + radiation therapy +/- ADT |
| CAN-2409 | ACTIVE_COMPARATOR | Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir |
| Placebo | PLACEBO_COMPARATOR | Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir |
| Name | Type | Description |
|---|---|---|
| Aglatimagene besadenovec + valacyclovir | BIOLOGICAL | Patients will receive three courses of ProstAtak® each consisting of aglatimagene besadenovec injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: 1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. 2. The second injection will be 0-3 days before initiation of radiation therapy. 3. The third injection will be 15-22 days after the 2nd injection. The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each AdV-tk injection. Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification. |
| Placebo + valacyclovir | BIOLOGICAL | Patients will receive three courses each consisting of placebo injection + oral valacyclovir. Placebo injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: 1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. 2. The second injection will be 0-3 days before initiation of radiation therapy. 3. The third injection will be 15-22 days after the 2nd injection. The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each placebo injection. Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification. |
| aglatimagene besadenovec | BIOLOGICAL | Aglatimagene besadenovec will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second aglatimagene besadenovec injection will be 2-3 weeks after the first followed by 14 days of valacyclovir. |
| placebo | BIOLOGICAL | Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir. |
| valacyclovir | DRUG | Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection. |
Inclusion Criteria include: * Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature * NCCN Intermediate Risk is defined as having at least one of the following: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c * High Risk with a s...