Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Administration of IS-002 · 1 trial · 1 indication
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...
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IS-002 is an investigational small molecule being studied for the treatment of prostate cancer. It is administered as a therapeutic intervention and is currently in clinical development, having completed a Phase 2 trial. The drug is not yet approved and remains under investigation for this indication.
IS-002 is being developed by Intuitive Surgical, Inc., a company traded on the NASDAQ under the ticker ISRG. The developer is responsible for the clinical development of this investigational small molecule for prostate cancer.
IS-002 is in Phase 2 of clinical development. A Phase 2 study has been completed, and the drug remains investigational. It has not yet advanced to Phase 3 or received regulatory approval.
IS-002 has one completed clinical trial, NCT05946603, titled 'IS-002 Phase 2 Prostate Cancer Study'. This was a Phase 2, sham-controlled, randomized study conducted in the United States with 59 male participants aged 18 years and older.
IS-002 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for prostate cancer. The drug is still in clinical development and has not been authorized for commercial use.