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| ID | Type | Description | Link |
|---|---|---|---|
| RAD5689-22-BED-IIT-439 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| STUDY00004720 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| NCI-2023-01322 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Blue Earth Diagnostics | INDUSTRY |
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This phase II trial evaluates Fluorine-18 radiohybrid prostate-specific membrane antigen (18F- rhPSMA)-7.3 positron emission tomography (PET)/computed tomography (CT) scans with and without furosemide for the reduction of bladder activity in patients with prostate cancer that has come back (recurrent) based on elevated levels of prostate-specific antigen (PSA) in the blood (biochemical) after prostate surgery (prostatectomy). Furosemide is a diuretic substance that increases the urine flow into the bladder, thereby decreasing the level of radioactivity within the bladder, which may help to see any abnormal areas that could be masked by the radioactivity within the bladder. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, rhPSMA ligand. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Adding furosemide to 18F-rhPSMA 7.3 PET/CT scans may help to better detect and treat patients with biochemically recurrent prostate cancer.
PRIMARY OBJECTIVE:
I. To determine if administering 20 mg furosemide intravenously (IV) at the time of radiotracer injection significantly reduces bladder activity compared with the same patient scanned without furosemide as internal control.
SECONDARY OBJECTIVES:
I. To compare detection rates of recurrent disease in blinded interpretations between the furosemide and non-furosemide 18FrhPSMA-7.3 PET/CT scans, with patients serving as their own internal controls.
II. To compare reader confidence in identifying prostate bed and other recurrent lesions on a 18F-rhPSMA-7.3 PET/CT with furosemide compared with 18F-rhPSMA-7.3 PET/CT without furosemide.
OUTLINE:
Patients receive 18F-rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT) | Experimental | Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bladder Activity as Measured by Bladder Standardized Uptake Value (SUV) Mean | Change in bladder SUV mean will be assessed using a paired t-test, or using a non-parametric equivalent such as a Wilcoxon signed rank test. Descriptively, change in bladder SUV mean will be reported for those administered 20 mg furosemide intravenously (IV) at the time of radiotracer injection first (group A), and those administered 20mg furosemide IV at the time of radiotracer injection second (group B). | Up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bladder and Renal Activity (Kidney SUV) | Kidney SUV - Change in bladder and renal activity will be assessed using paired t-tests, or using non-parametric equivalents such as a Wilcoxon signed rank tests. Descriptively, bladder and renal activity will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B). |
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Inclusion Criteria:
Exclusion Criteria:
- Inability to undergo 18F-rhPSMA PET-CT, contraindications to furosemide or urinary incontinence
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| Name | Affiliation | Role |
|---|---|---|
| Charles V. Marcus, MBBS | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| Emory University Hospital/Winship Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39848765 | Derived | Lawal IO, Mushtaq A, Jani AB, Rupji M, Dhere VR, Patel SA, Bilen MA, Patel PR, Sebastian NT, Switchenko JM, Schuster DM, Marcus C. Diuresis During 18F-Flotufolastat (rhPSMA-7.3) PET/CT Improves Recurrence Detection After Prostatectomy: A Prospective Phase II Trial. J Nucl Med. 2025 Feb 3;66(2):230-237. doi: 10.2967/jnumed.124.268574. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A - Complete 18F-rhPSMA-7.3 PET/CT #1 with furosemide followed by without furosemide . | Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| V1 (1-30 days after consent/screening) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2024 |
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| F18-rhPSMA-7.3 | Other | Given IV |
|
|
| Positron Emission Tomography | Procedure | Undergo PET/CT scan |
|
|
| Computed Tomography | Procedure | Undergo PET/CT scan |
|
|
| Up to 2 weeks |
| Change in Bladder and Renal Activity (Bladder Volume, ML) | (Bladder Volume, ML) - Change in bladder and renal activity will be assessed using paired t-tests, or using non-parametric equivalents such as a Wilcoxon signed rank tests. Descriptively, bladder and renal activity will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B). | Up to 2 weeks |
| Recurrent Disease Rate | Defined as presence of unequivocal soft tissue radiotracer uptake that is characteristic of malignancy in the prostate bed and/or surrounding soft tissues and within pelvic lymph nodes. Recurrent disease rates will be compared (furosemide versus non-furosemide flotufolastat F-18 radiohybrid prostate-specific membrane antigen (18F-rhPSMA)-7.3 positron emission tomography (PET) scans using McNemar's tests. Rates will be reported, along with 95% exact confidence intervals using the Clopper-Pearson method. Descriptively, recurrent disease rate will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B). | Up to 2 weeks |
| Reader Confidence Score | The readers' confidence in identifying prostate bed, pelvic and retroperitoneal nodal disease and other recurrence on 18F-rhPSMA-7.3 PET/computed tomography (CT) with furosemide compared with the 18F-rhPSMA-7.3 PET/CT without furosemide will be scored using a 5-point Likert scale ( 1 - Definitely benign, 2- probably benign, 3 - equivocal, 4 - probably malignant, 5 - definitely malignant). This analysis will be descriptive, with summary statistics reported with and without furosemide. Variables will be summarized using frequencies and percentages. In our analysis, 1,2 (no) will be considered benign while 3,4,5 malignant (yes). A high Likert score indicates that the reader is confident that the finding on the imaging is cancer (worse outcome), while a low score indicates no cancer (better outcome). All tests will be two-sided with an alpha level of 0.05, unless otherwise noted. Statistical analysis will be conducted using SAS 9.4. | 1 Month |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| Emory Johns Creek Hospital | Johns Creek | Georgia | 30097 | United States |
| FG001 |
| Group B - Complete 18F-rhPSMA-7.3 PET/CT #1 without furosemide followed by with furosemide. |
Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans without and with furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan |
| COMPLETED |
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| NOT COMPLETED |
|
| V2 (2-7days after PET/CT #1) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT) | Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Change in Bladder Activity as Measured by Bladder Standardized Uptake Value (SUV) Mean | Change in bladder SUV mean will be assessed using a paired t-test, or using a non-parametric equivalent such as a Wilcoxon signed rank test. Descriptively, change in bladder SUV mean will be reported for those administered 20 mg furosemide intravenously (IV) at the time of radiotracer injection first (group A), and those administered 20mg furosemide IV at the time of radiotracer injection second (group B). | Posted | Mean | Standard Deviation | SUV | Up to 2 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Bladder and Renal Activity (Kidney SUV) | Kidney SUV - Change in bladder and renal activity will be assessed using paired t-tests, or using non-parametric equivalents such as a Wilcoxon signed rank tests. Descriptively, bladder and renal activity will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B). | Posted | Mean | Standard Deviation | SUV | Up to 2 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Bladder and Renal Activity (Bladder Volume, ML) | (Bladder Volume, ML) - Change in bladder and renal activity will be assessed using paired t-tests, or using non-parametric equivalents such as a Wilcoxon signed rank tests. Descriptively, bladder and renal activity will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B). | Posted | Mean | Standard Deviation | ML | Up to 2 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Recurrent Disease Rate | Defined as presence of unequivocal soft tissue radiotracer uptake that is characteristic of malignancy in the prostate bed and/or surrounding soft tissues and within pelvic lymph nodes. Recurrent disease rates will be compared (furosemide versus non-furosemide flotufolastat F-18 radiohybrid prostate-specific membrane antigen (18F-rhPSMA)-7.3 positron emission tomography (PET) scans using McNemar's tests. Rates will be reported, along with 95% exact confidence intervals using the Clopper-Pearson method. Descriptively, recurrent disease rate will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B). | Posted | Number | Participants | Up to 2 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | Reader Confidence Score | The readers' confidence in identifying prostate bed, pelvic and retroperitoneal nodal disease and other recurrence on 18F-rhPSMA-7.3 PET/computed tomography (CT) with furosemide compared with the 18F-rhPSMA-7.3 PET/CT without furosemide will be scored using a 5-point Likert scale ( 1 - Definitely benign, 2- probably benign, 3 - equivocal, 4 - probably malignant, 5 - definitely malignant). This analysis will be descriptive, with summary statistics reported with and without furosemide. Variables will be summarized using frequencies and percentages. In our analysis, 1,2 (no) will be considered benign while 3,4,5 malignant (yes). A high Likert score indicates that the reader is confident that the finding on the imaging is cancer (worse outcome), while a low score indicates no cancer (better outcome). All tests will be two-sided with an alpha level of 0.05, unless otherwise noted. Statistical analysis will be conducted using SAS 9.4. | Posted | Number | participants | 1 Month |
|
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 | Complete 18F-rhPSMA-7.3 PET/CT #1 with furosemide Study Visit 1 (1-30 days after consent/screening) | Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | Complete 18F-rhPSMA-7.3 PET/CT #1 without furosemide Study Visit 2 (2-7days after PET/CT #1) | Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Complete 18F-rhPSMA-7.3 PET/CT #1 without furosemide Visit 1 (1-30 days after consent/screening) | Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans without furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan | 0 | 10 | 0 | 10 | 1 | 10 |
| EG003 | Complete 18F-rhPSMA-7.3 PET/CT #1 with furosemide Study Visit 2 (2-7days after PET/CT #1) | Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with furosemide IV on study. Furosemide: Given IV F18-rhPSMA-7.3: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan | 0 | 10 | 0 | 10 | 0 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising at injection site | General disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Schuster | Emory University | 4047781900 | dschust@emory.edu |
| Jul 14, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 26, 2024 | Jul 14, 2025 | ICF_001.pdf |
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| 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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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D009682 | Magnetic Resonance Spectroscopy |
| D014965 | X-Rays |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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|
|
| Units | Counts |
|---|---|
| Participants |
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