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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05946603 | IS-002 Phase 2 Prostate Cancer Study | PHASE2 | COMPLETED | 59 | — | — | Jun 16, 2023 | May 23, 2025 | Sep 4, 2025 | 4 | United States |
The proportion of subjects with ≥1 PSMs on final histopathologic assessment in the Intervention arm and the Control arm.
The mean number of PSMs on final histopathologic assessment in the Intervention arm and the Control arm.
| Arm | Type | Description |
|---|---|---|
| RARP + IS-002 | SHAM_COMPARATOR | Subjects will receive IS-002, but during surgery NO fluorescence imaging will be performed. |
| RARP + IS-002 + intraoperative near-infrared imaging | EXPERIMENTAL | Subjects will receive IS-002, and during surgery fluorescence imaging will be performed. |
| Name | Type | Description |
|---|---|---|
| Administration of IS-002 | DRUG | Intravenous administration of IS-002 approximately 24 hours prior to surgery |
| Firefly fluorescent imaging | DEVICE | Near-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002 |
| robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection | PROCEDURE | Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection |
Inclusion criteria 1. Subjects aged 18 to 75. 2. Subject has a confirmed adenocarcinoma of the prostate as defined by (histo-) pathology. 3. Subject has CAPRA ≥6; or ≥T3 disease on imaging (TRUS and/or MRI); or a Gleason sum score ≥8; or regional lymphadenopathy suspicious for nodal metastases on i...