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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00052383 | Other Identifier | JHM IRB |
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This research is being done to see if an investigational radioactive drug called 18F-DCFBC can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), [18F]DCFBC (DCFBC) PET imaging for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. The investigators propose to assess the ability of DCFBC PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by standard conventional imaging modalities (CIM) for prostate cancer which includes IV contrast CT of chest/abdomen/pelvis and whole body bone scintigraphy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DCFBC | Experimental | Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-DCFBC | Drug | 18F-DCFBC is a radiofluorinated small-molecule inhibitor of prostate-specific membrane antigen (PSMA). A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) | Measurement of sensitivity of DCFBC PET to CIM (contrast-enhanced CT and bone scintigraphy) for detection of metastatic prostate cancer based on number of lesions that are detected on PET/CT, in agreement with CT and CIM. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Detection of New or Progression of Metastasis | Sensitivity of DCFBC-PET and conventional imaging modalities (CIM), which include bone scintigraphy (BS) and contrast-enhanced computed tomography (CECT) to detect new or progression of metastases at follow-up, where "equivocal" lesions are considered negative. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive, therefore, sensitivity is a proportion of responsive lesions to the total number of lesions analyzed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zsolt Szabo, M.D | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
22 participants enrolled, 5 screen failures, therefore only 17 participants started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 18F-DCFBC | Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 18F-DCFBC | Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) | Measurement of sensitivity of DCFBC PET to CIM (contrast-enhanced CT and bone scintigraphy) for detection of metastatic prostate cancer based on number of lesions that are detected on PET/CT, in agreement with CT and CIM. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive. | Combined Imaging Modality (CIM) refers to both CT and BS imaging. The total number of lesions analyzed by both CT and BS (CIM) are 235 (as represented by PET-positive and PET-negative, equivocal CIM). There is overlap in the number of lesions detected by conventional imaging modalities (ie: bone scan and computed tomography) | Posted | Number | lesions detected | 24 Months | Lesions | Lesions |
|
Up to 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 18F-DCFBC | 18F-DCFBC | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Rowe, M.D, Ph.D | Johns Hopkins University | 4105021520 | srowe8@jhmi.edu |
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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 |
|---|---|
| C530683 | N-(N-((S)-1,3-Dicarboxypropyl)carbamoyl)-4-(18F)fluorobenzyl-L-cysteine |
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|
| up to 1 year |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Prostate specific antigen (PSA) | Mean | Standard Deviation | ng/mL |
|
| Serum folate | Count of Participants | Participants |
|
| Red cell folate | Normal range = 160-855 ng/mL | Data was not available in 4 participants | Mean | Full Range | ng/mL |
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| Testosterone <20 ng/mL | Count of Participants | Participants |
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| Testosterone | Mean testosterone level (ng/mL) for participants with values other than "<20 ng/mL" | Mean | Full Range | ng/mL |
|
| Prior prostate cancer therapy | Count of Participants | Participants |
|
Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer.
|
|
| Secondary | Sensitivity of Detection of New or Progression of Metastasis | Sensitivity of DCFBC-PET and conventional imaging modalities (CIM), which include bone scintigraphy (BS) and contrast-enhanced computed tomography (CECT) to detect new or progression of metastases at follow-up, where "equivocal" lesions are considered negative. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive, therefore, sensitivity is a proportion of responsive lesions to the total number of lesions analyzed. | Follow-up CIM was only available for 12 of the 17 participants. 92% of the lesions detected via 18F-DCFBC PET were marked as true positive. | Posted | Number | 95% Confidence Interval | proportion of responsive lesions | up to 1 year |
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| 17 |
| 0 |
| 17 |
| 4 |
| 17 |
| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Blood in stool | Gastrointestinal disorders | Non-systematic Assessment |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| Combined CIM (BS and CECT) |
|