68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery

Study Overview
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Brief Summary
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This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer, and reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.

Detailed Description
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OBJECTIVES: To evaluate 68Ga-PSMA-11 PET/MRI for detection of tumor metastases in patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. To assess sensitivity (positive predictive value) and specificity (negative predictive value) of 68Ga-PSMA-11 PET/MRI for the detection of regional nodal metastases compared to pathology at radical prostatectomy. OUTLINE: Participants will receive 68Ga-PSMA-11 intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection. After completion of study, patients are followed up at 24 to 48 hours.

Official Title
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68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer

Conditions
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Stage II Prostate Adenocarcinoma, Stage III Prostate Adenocarcinoma

Intervention / Treatment
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* Drug: 68Ga-PSMA-11
* Procedure: Magnetic resonance imaging (MRI)
* Procedure: Positron Emission Tomography (PET)


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Biopsy-proven prostate adenocarcinoma Planned prostatectomy with lymph node dissection Intermediate- to high-risk disease (as determined by elevated prostate-specific antigen (PSA) [PSA > 10], T stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors) Karnofsky performance status of ≥ 50 [or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent] Diagnostic CT or MRI performed within 90 days of the research PET Able to provide written consent ExCLUSION CRITERIA Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal ablation techniques (HiFu) Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery Metallic implants (contraindicated for MRI)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-PSMA PET/MRI<br>Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection. | Drug: 68Ga-PSMA-11<br>* Undergo 68Ga-PSMA-11 PET/MRI<br>* Other names: Heidelberg compound;Procedure: Magnetic resonance imaging (MRI)<br>* Undergo 68Ga-PSMA-11 PET/MRI<br>* Other names: NMRI;Procedure: Positron Emission Tomography (PET)<br>* Undergo 68Ga-PSMA-11 PET/MRI<br>* Other names: Proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes | 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect regional nodal and distant metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. The data will be analyzed by imaging interpretation. Each participant will be interpreted as either positive or negative for the presence of metastatic disease by 68Ga-PSMA PET/MRI, as assessed by imaging interpretation. The outcome will be expressed as the number of participants with metastatic disease, as identified by PET/MRI, a number without dispersion. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes | Participants that undergo prostatectomy will be evaluated for prostate cancer metastasis to the lymph nodes as determined by histopathology. Each participants will be interpreted as either positive or negative for the presence of metastatic disease by histopathology. The outcome will be expressed as the number of participants with metastatic disease, as identified by histopathology, a number without dispersion. | 1 Day | 
| Sensitivity of 68Ga-PSMA-11 PET/MRI | 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), sensitivity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, sensitivity means the 2 assessments are in agreement that the participant truly has (ie, true-positive) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is detected (true-positive), a number without dispersion. | 1 Day | 
| Specificity of 68Ga-PSMA-11 PET/MRI | 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), specificity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, specificity means the 2 assessments are in agreement that the participant does not (ie, true-negative) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is not detected (true-negative), a number without dispersion. | 1 Day |