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This is an open-label study comparing the imaging characteristics of 123-I-MIP-1072 and ProstaScint® (111-In-capromab pendetide)in patients with metastatic prostate cancer. Eligible patients will receive a dose of 123-I-MIP-1072 and have imaging studies and safety assessments (physical examination, vital signs, electrocardiogram, clinical laboratory tests) performed during the subsequent 24 hours. Two weeks later, patients will return for additional safety assessments and will receive ProstaScint® if they don't already have a pre-existing ProstaScint scan. Final assessments will be performed two weeks after the ProstaScint® scan unless there is a difference between the 123-I-MIP-1072 and ProstaScint® scans. If this is the case, another dose of 123-I-MIP-1072 will be given 12 weeks later, and imaging studies repeated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 123-I-MIP-1072 | Drug | Single 10 mCi intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the imaging sensitivity and specificity of 10.0 mCi or 5.0 mCi of 123I MIP 1072 compared to 5 mCi of 111In capromab pendetide in subjects with metastatic prostate cancer by determining the presence and extent of the disease. | 24 hours post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Examine the imaging sensitivity and specificity of 10.0 mCi or 5.0 mCi of 123I MIP 1072 compared to 5 mCi of 111In capromab pendetide on a per lesion basis in subjects with metastatic prostate cancer | Through 2 weeks post-injection | |
| To describe the safety of administering 10.0 mCi and 5.0 mCi of 123I MIP 1072 for the detection of metastatic prostate cancer |
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Subjects must meet all of the following criteria to be enrolled in this study.
Male aged 18 years or older
Signed written informed consent and willingness to comply with protocol requirements
Histologic diagnosis of prostate cancer by validated history and/or biopsy of the prostate or of a metastatic lesion.
Evidence of metastatic disease as documented by an abnormal bone scan and CT scan or MRI plus:
Castration/anti androgen therapy naĂ¯ve/sensitive:
If on anti androgen therapy, must have initiated therapy at least 4 weeks prior to treatment.
Castration/anti androgen therapy resistant:
I. PSA progression: 2 serial rising PSA determinations at least 14 days apart over the PSA nadir, with the last measurement ≥ 2 ng/mL
II. Progression of measurable disease, or progression of non measurable disease as defined by:
i. Soft tissue disease: The appearance of one or more new lesions, and/or unequivocal worsening of non measurable disease when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response, or ii. Bone disease: Appearance of two or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre castration studies if there was no response.
III. Increased uptake of pre existing lesions on bone scan does not constitute progression.
IV. Testosterone ≤ 50 ng/dL achieved via medical or surgical castration.
Male subjects who are fertile agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method throughout the study period. A second form of barrier birth control must be utilized if a subject's partner is using oral contraception until at least seven days after the last injection.
Karnofsky performance is ≥ 50
Adequate hematologic, renal and liver function:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Dobkin, MD | Pacific Coast Imaging | Principal Investigator |
| Stanley Goldsmith, MD | NY Presbyterian Hospital - Weill Cornell Medical Center | Principal Investigator |
| Edward Coleman, MD | Duke University | Principal Investigator |
| Arif Hussain, MD | University of Maryland | Principal Investigator |
| Mack Roach, MD | University of California, San Francisco | Principal Investigator |
| Kevin Slawin, MD | Vanguard Urologic Research Foundation | Principal Investigator |
| Samuel L Kipper, MD | West Coast Radiology Centerse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Radiology Centers | Laguna Niguel | California | 92677 | United States | ||
| Pacific Coast Imaging |
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| 111-In capromab pendetide | Drug | Single 5 mCi intravenous injection |
|
|
| 123-I-MIP-1072 | Drug | Single 5 mCi intravenous injection |
|
|
| Through 2 weeks post-injection |
| Newport Beach |
| California |
| 92663 |
| United States |
| University of California - San Francisco | San Francisco | California | 94143 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| New York Presbyterian Hospital - Weill Cornell Medical College | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Vanguard Urologic Research Foundation | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C101315 | Capromab Pendetide |
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