68Ga PSMA PET for Patients With Biochemical Recurrence of Prostate Cancer

Study Overview
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Brief Summary
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This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker. To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

Detailed Description
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This study evaluates PSMA-HBED-CC labelled with Gallium-68, abbreviated 68Ga PSMA. This is a radiotracer that attaches to receptors in the membrane of prostate cancer cells. The 68Ga PSMA is identified using a positron emission tomography (PET) scanner. It is believed that 68Ga PSMA will identify prostate cancer more precisely than normal imaging methods (MRI, CT, or ultrasound). Imaging is key to successful treatment - disease must be identified to be treated. Men who have biochemical recurrence of prostate cancer are invited to test 68Ga PSMA. Participants undergo the 68Ga PSMA PET scan before further treatment. Clinical information, including any MRI, CT, or ultrasound imaging and biopsy/surgery information, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging. The study team will collect this information for about 1 year after the PSMA scan. Depending on findings, participants may be invited back for a second 68Ga PSMA scan. This is done if the first scan showed positive lymph nodes or soft tissue metastases but a surgery or biopsy result does not. The results from these scans will be shared with the participant. Results will also be entered into the participant's medical record and shared with the treating oncologists.

Official Title
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68Ga PSMA-HBED-CC PET in Patients With Biochemical Recurrence

Conditions
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Prostatic Cancer Recurrent, Prostatic Cancer Metastatic, Prostate Cancer, Prostatic Neoplasm, Prostatic Neoplasms, Castration-Resistant

Intervention / Treatment
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* Drug: Ga-68 PSMA-HBED-CC PET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically proven prostate adenocarcinoma Rising PSA after definitive therapy with prostatecomy or radiation therapy (external beam or brachytherapy) If post-radical prostatecomy, PSA > 0.2 ng/mL measured > 6 weeks post-operative and confirmed persistent PSA > 0.2 ng/mL (AUA recommendation for biochemical recurrence) If post-radiation therapy, PSA that is ≥ 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence) Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations) No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion) Karnofsky performance status (KPS) ≥ 50 (ECOG/WHO of 0, 1, or 2) Ability to understand and willingness to provide informed consent Exclusion Criteria: Cannot receive furosemide History of Stevens Johnson syndrome History or diagnosis of Paget's disease Malignancy other than current disease under study Allergy to sulfa or sulfa-containing medications Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

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 scan<br>Ga-68 PSMA-HBED-CC PET | Drug: Ga-68 PSMA-HBED-CC PET<br>* Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.<br>* Other names: Gallium-68 PSMA-HBED-CC PET scan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine sensitivity on a per-subject basis of 68Ga PSMA PET scans for detection of tumor location | Sensitivity will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available. | Up to 12 months after 68Ga PSMA PET scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine positive predictive value on a per-subject and per-region basis of 68Ga PSMA PET scans for detection of tumor location | Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available. | 3 and 12 months after 68Ga PSMA PET scan | 
| Evaluate adverse events of 68Ga PSMA PET scan | Adverse events will be determined through clinical assessment and categorized by CTCAE 4.03 | through 24 hours post-injection of 68Ga PSMA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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68Ga-PSMA-11, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga PSMA-HBED-CC