Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

Study Overview
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Brief Summary
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The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

Detailed Description
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Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.

Official Title
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Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Ga-68 labeled PSMA-11 PET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathological proven prostate adenocarcinoma. Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy). Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and, Confirmatory persistent PSA greater than 0.2 ng/mL Post-radiation therapy -ASTRO-Phoenix consensus definition Nadir + greater than or equal to 2 ng/mL rise in PSA Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent). Age > 18. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: Investigational therapy for prostate cancer. Unable to lie flat, still or tolerate a PET scan. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer. Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).

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: Ga-68 labeled PSMA-11 PET<br>PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. | Drug: Ga-68 labeled PSMA-11 PET<br>* Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.<br>* Other names: Ga-68 labeled HBED-CC PSMA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation | PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method. | 1 month | 
| Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation | PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up | PPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI. | 1 month | 
| PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up | PPVs on a per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI. | 1 month | 
| Sensitivity on a Per-patient Basis | Sensitivity, on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method. | 1 month | 
| Sensitivity on a Per-region Basis | Sensitivity, on a per-region basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method. | 1 month | 
| Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value | Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-<0.5; 0.5-<1.0; 1.0-<2.0; 2.0-<5.0, and ≥5.0). | 1 month | 
| Inter-reader Agreement Per-region | Inter-reader reproducibility for positivity at region level was reported using the Fleiss' Kappa test for multiple readers. Kappa value varies from 0 (no agreement) to 1 (perfect agreement). | 1 month | 
| Percentage of Participants With Change in Clinical Management | Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET. | Up to 1 year | 
| Safety Assessment - Heart Rate | Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated. | 1 day | 
| Safety Assessment - Blood Pressure | Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated. | 1 day |