Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging 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 its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

Official Title
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Gallium-68 PSMA-11 PET Imaging 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 Histopathologically proven prostate adenocarcinoma. Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy). Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP. Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy Nadir + greater than or equal to 2 ng/mL rise in PSA Karnofsky performance status of > 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 Unable to lie flat, still or tolerate a PET scan. Concomitant investigational therapy. Patient undergoing active treatment for non-prostate malignancy, 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 |
| --- | --- | --- |
| True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. | 1 Day | 
| True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. | 1 Day | 
| True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. | 1 Day | 
| True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Predictive Value (PPV) for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. | 1 Day | 
| PPV for Detection of Tumor Location in Visceral Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in visceral tissue as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. | 1 Day | 
| PPV for Detection of Tumor Location in Bone Metastasis Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer metastasized in the bone as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. | 1 Day | 
| PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. | 1 Day | 
| True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. | 1 Day | 
| True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. | 1 Day | 
| True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. | 1 Day | 
| True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only | The true positive rate or detection rate is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. | 1 Day | 
| PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy | 1 Day | 
| PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the visceral tissue as confirmed by by histopathology/biopsy | 1 Day | 
| PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the bone tissue as confirmed by by histopathology/biopsy | 1 Day | 
| PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy | 1 Day | 
| Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value | Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA value (0.2- <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - <5.0, >=5.0) will be summarized in tabular format for participants with PSMA positive disease, independent of pathology, imaging or clinical follow-up. | 1 Day | 
| Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment | Detection rates (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior cancer treatment (Prostatectomy, Radiation, or Prostatectomy plus Radiation) will be summarized in tabular format. | 1 Day | 
| Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT) | Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior use of ADT as a cancer treatment (Prior treatment with ADT, No prior treatment with ADT) will be summarized in tabular format. | 1 Day | 
| Percent of Participants With a Change in Clinical Management | Impact of 68Ga-PSMA-11 PET on clinical management in patients with biochemical recurrence (BCR) was measured using Pre-PET (Q1), post-PET (Q2), and post-treatment (Q3) questionnaires sent to referring physicians recording site of recurrence and intended (Q1 to Q2 change) and implemented (Q3) therapeutic and diagnostic management. Percentage of participants with a change in clinical management will be reported using descriptive statistics based on qualitative physician responses from the change in management surveys. | Up to 6 months | 
| Rate of Inter-reader Reproducibility for Positivity | Inter-reader reproducibility for positivity at the patient level will be reported using the Fleiss' Kappa test for multiple readers | 1 Day | 
| Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events | All grade 3 and above adverse events will be recorded using the NCI CTCAE v4.0. The Investigator will assign attribution of the possible association of the event with use of the investigational drug. | Up to 30 days |