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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00992745 | A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer | PHASE1 | COMPLETED | 24 | — | — | Oct 1, 2009 | Sep 1, 2011 | Oct 12, 2011 | 7 | United States |
| NCT00712829 | Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents | PHASE1 | COMPLETED | 12 | — | — | May 1, 2008 | Jan 1, 2009 | Oct 12, 2011 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| Previous ProstaScint® | EXPERIMENTAL | Subjects with a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 alone. |
| No Previous ProstaScint® | EXPERIMENTAL | Subjects without a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 and 111-In capromab pendetide imaging. |
| 1 | EXPERIMENTAL | 123-I-MIP-1072 administration followed by 123-I-MIP-1095 administration two weeks later. |
| 2 | EXPERIMENTAL | 123-I-MIP-1095 administration followed by 123-I-MIP-1072 administration two weeks later. |
| Name | Type | Description |
|---|---|---|
| 123-I-MIP-1072 | DRUG | Single 10 mCi intravenous injection |
| 111-In capromab pendetide | DRUG | Single 5 mCi intravenous injection |
| 123-I-MIP-1095 | DRUG | 10 mCi intravenous injection given one time during the study |
Subjects must meet all of the following criteria to be enrolled in this study. 1. Male aged 18 years or older 2. Signed written informed consent and willingness to comply with protocol requirements 3. Histologic diagnosis of prostate cancer by validated history and/or biopsy of the prostate or of a...