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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00139990 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| Progenics Pharmaceuticals, Inc. | INDUSTRY |
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This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population.
This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population. 150 biopsy-naïve patients with an elevated PSA (2-10 ng/mL) will be enrolled in this study.
Within 28 days of informed consent, patients will undergo an 18F-DCFPyL PET/CT. All scans will be read by a single experienced radiologist who will identify regions of interest (ROI) with discrete radiotracer uptake. The maximum SUV value (SUVmax) of each ROI will be recorded. For patients without a detectable ROI, the mean SUV (SUVmean) of a 1-2 cm volume of the prostate will instead be recorded.
One to 28 days following PET/CT imaging, a systematic 12 to 14 core TRUS-guided prostate biopsy will be performed. Immediately following completion of systematic TRUS biopsies, fusion-targeted biopsies of all PET and/or MRI visible lesions will be performed, taking an additional 2 to 3 cores from each radiographic ROI. All biopsy cores will be assessed for Gleason score and percent cancer involvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DCFPyL Injection | Experimental | A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-DCFPyL Injection | Drug | A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of 18F-DCFPyL PET/CT to detect clinically significant prostate cancer on prostate biopsy relative to serum prostate specific antigen (PSA) | Measure the diagnostic accuracy of 18F-DCFPyL PET/CT and compare it with serum PSA for detecting clinically significant prostate cancer on prostate biopsy | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of 18F-DCFPyL PET/CT relative to PSA | Measure the diagnostic accuracy of 18F-DCFPyL PET/CT relative to serum PSA for detecting clinically significant prostate cancer as defined by the following alternative definitions: Gleason score ≥4+3=7; Gleason score ≥3+4 or >50% involvement of ≥1 core with Gleason score ≥3+3=6 prostate cancer; Gleason score ≥3+4 or >70% involvement of ≥1 core with Gleason score ≥3+3=6 prostate cancer; Gleason score ≥3+4=7, or >2 cores with Gleason score ≥3+3=6, or >50% involvement of ≥1 core with Gleason score ≥3+3=6 prostate cancer. |
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Inclusion Criteria:
Exclusion Criteria:
Study is For Prostate Cancer in Men
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| Name | Affiliation | Role |
|---|---|---|
| Mohamad Allaf, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SKCCC | Baltimore | Maryland | 21287 | United States |
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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 |
|---|---|
| C572626 | 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid |
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| 4 years |
| Sensitivity of 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer relative to mpMRI | Measure the diagnostic accuracy of 18F-DCFPyL PET/CT relative to mpMRI for detecting clinically significant prostate cancer by the various tested definitions | 4 years |
| Sensitivity and diagnostic accuracy of 18F-DCFPyL PET/CT relative to the phi blood test for detecting clinically significant prostate cancer by the various tested definitions | Measure the diagnostic accuracy of 18F-DCFPyL PET/CT relative to the phi blood test for detecting clinically significant prostate cancer by the various tested definitions | 4 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |