| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07001 | Registry Identifier | Clinical Trials Reporting Program (CTRP) | |
| 18-006159 | Other Identifier | Mayo Clinic Institutional Review Board | |
| MC1952 | Other Identifier | Mayo Clinic |
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Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT Ga-68 PSMA | Experimental | Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT |
|
| PET/CT F-18 Labeled PSMA 1007 | Experimental | F-18 Labeled PSMA 1007 PET/CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga-68 PSMA11 | Drug | Ga-68 PSMA11 PET/CT for detection of tumor location |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Detection on PET/CT | Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up. | 12 Months post PET/CT |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of PSMA and C-11 choline PET on clinical management | Descriptive statistics will be used to evaluate the impact of PSMA and C-11 choline PET on clinical management | 12 Months |
| Incidence of adverse events attributable to PSMA |
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Inclusion Criteria:
Histopathological proven prostate adenocarcinoma.
Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. > 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies)
Karnofsky performance status of 50 (or ECOG/WHO equivalent).
CT or as part of the PET study or performed within one month of PSMA PET.
Age > 18.
Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Val Lowe, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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The IPD data from this trial will be available to other researchers that will collate similar data from multiple sites to provide data to the FDA.
After completion of the trial and IPD will be available for 2 years.
Researchers collating data from multiple sites for submission to the FDA will be provided access to the IPD.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
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| F-18 PSMA 1007 |
| Drug |
F-18 PSMA 1007 PET/CT for detection of tumor location |
|
Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
| 12 Months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |