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Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard).
Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4).
Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments.
Assess quality of life changes from preoperative baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy | Experimental | 1. Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-PSMA-11 PET Scan | Diagnostic Test | Patients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension | Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles | The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery. |
| Specificity of PSMA-PET and MRI | Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard. | Pre-surgery prediction. |
| Measure | Description | Time Frame |
|---|---|---|
| 1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET | Rate of treatment changes | 60 Days |
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Inclusion Criteria:
1. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with:
Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI
Exclusion Criteria:
1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
2. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging).
3. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38785259 | Derived | Bahler CD, Tachibana I, Tann M, Collins K, Swensson JK, Green MA, Mathias CJ, Tong Y, Yong C, Boris RS, Brocken E, Hutchins GD, Sims JB, Hill DV, Smith N, Ferari C, Love H, Koch MO. Comparing Magnetic Resonance Imaging and Prostate-Specific Membrane Antigen-Positron Emission Tomography for Prediction of Extraprostatic Extension of Prostate Cancer and Surgical Guidance: A Prospective Nonrandomized Clinical Trial. J Urol. 2024 Aug;212(2):290-298. doi: 10.1097/JU.0000000000004032. Epub 2024 May 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PSMA-PET and MRI in Men Scheduled for Prostatectomy | Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo PSMA PET and MRI. There were 100 prostate lobes examined with 2 lobes per patient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PSMA-PET and MRI in Men Scheduled for Prostatectomy | Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo PSMA PET and MRI. There were 100 prostate lobes examined with 2 lobes per patient. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension | Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles | Men diagnosed with prostate cancer often seek surgical treatment. Surgical treatment--radical prostatectomy--is currently guided by clinical parameters (PSA, pathology) and MRI imaging. These men often have considerable concerns about the balance of cancer control and quality of life after the surgery. There were 100 prostate lobes examined with 2 lobes per patient. One patient was enrolled but did not complete study procedures. | Posted | Number | 95% Confidence Interval | percentage | The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery. | prostate lobes | prostate lobes |
|
1 day, the day of imaging.
Patient were monitored during injection of the (Ga68)PSMA-11 and afterwards for at least 60minutes.
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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 | PSMA-PET and MRI in Men Scheduled for Prostatectomy | Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo PSMA PET and MRI. There were 100 prostate lobes examined with 2 lobes per patient. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Lehman, RN, Senior Research Leader | Indiana University, Department of Urology | 317-948-9575 | jgeck@iu.edu |
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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 | Mar 29, 2022 | May 16, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2022 | May 16, 2023 | 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 |
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68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results informs treatment decisions versus the treatment decisions with only MRI knowledge.
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Two separate radiologists (one from Nuclear Medicine and one from MRI) will read images in a blinded fashion and provide their findings for the surgeons to use in treatment planning.
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| PSA | Median | Inter-Quartile Range | ng/mL |
|
| Gleason Grade-group, final pathology | This is pathology. Prostate cancer uses Gleason grading system, which is organized as the Grade group as follows: 3+3 = 1, 3+4 = 2, 4+3 = 3, 4+4 = 4, 4+5 = 5, Grade group 1 indicates a lower grade cancer. | Number | participants |
|
| Pathologic stage (T) | T-stage: pT2 (organ confined), pT3a (extra-prostate extension), pT3b (Seminal vesicle invasion), pT4 (outside invasion) | Number | participants |
|
| Pathologic stage (N) | This measure reports the total number of participants with positive lymph nodes. This is also referred to as pathologic N-stage. The N-stage indicates the number of total patients who had positive lymph nodes. | Count of Participants | Participants |
|
Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery There were 100 prostate lobes examined with 2 lobes per patient. |
| OG001 | MRI in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy | Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo imaging with MRI in addition to PSMA-PET. There were 100 prostate lobes examined with 2 lobes per patient. |
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|
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| Primary | Specificity of PSMA-PET and MRI | Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard. | Posted | Number | 95% Confidence Interval | Percentage | Pre-surgery prediction. | prostate lobes | prostate lobes |
|
|
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| Secondary | 1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET | Rate of treatment changes | Posted | Number | participants | 60 Days |
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| 0 |
| 51 |
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| 51 |
| 0 |
| 51 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |