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This is a single blinded, randomized, cross-over design. Up to 12 patients will be randomly administered a single 10.0 mCi dose of 123I-MIP-1072 or 123I-MIP-1095 (study drugs). The second (alternate) study drug will be administered approximately 14 days after the first. A final follow-up visit will occur approximately 2 weeks after the injection of the alternate study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 123-I-MIP-1072 | Drug | 10 mCi intravenous injection given one time during the study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the pharmacokinetics and organ radiation dosimetry of 123-I-MIP-1072 and 123I-MIP-1095 in patients with prior histological diagnosis of prostate cancer with evidence of recurrent metastatic disease. |
| Measure | Description | Time Frame |
|---|---|---|
| To examine whole body excretion and metabolism of 123-I-MIP-1072 and 123-I-MIP-1095 in patients with recurrent metastatic prostate cancer. | ||
| To evaluate the safety of administering a 10.0 mCi dose of 123-I-MIP-1072 and 123-I-MIP-1095 to patients with recurrent metastatic prostate cancer. |
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Inclusion Criteria:
Have a prior histological diagnosis of prostate cancer.
Have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI plus:
Have platelet count of > 50,000/mm3
Have neutrophil count of > 1,000/mm3
Provide written informed consent and willing to comply with protocol requirements
Greater than or equal to 18 years of age
Can be on hormonal therapy if dose stable for > 90 days
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Institutes - Neuroradiology Division | Baltimore | Maryland | 21287 | United States | ||
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| 123-I-MIP-1095 |
| Drug |
10 mCi intravenous injection given one time during the study |
|
| Optimize imaging parameters |
| New York Weill Cornell Medical Center - New York Presbyterian Hospital |
| New York |
| New York |
| 10021 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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