68Ga PSMA in Preprostatectomy Patients

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 are scheduled to undergo a prostatectomy are invited to test 68Ga PSMA. Participants undergo the 68Ga PSMA PET scan before the prostatectomy. Information from the prostatectomy, including any MRI, CT, or ultrasound imaging, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging. Depending on the prostatectomy 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 the surgery/biopsy results do 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 in Intermediate to High-Risk Preprostatectomy Patients

Conditions
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Prostate Cancer, Prostatic Neoplasm, Prostatic Neoplasms, Castration-Resistant, Prostatic Neoplasm of Uncertain Behavior

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: Biopsy-proven prostate adenocarcinoma Intermediate to high-risk disease, defined as one of the following factors: PSA > 10, T2b or greater, or a Gleason score of 7 or greater A PSA level resulted within the past 2 months Planned prostatectomy with lymph node dissection Karnofsky performance status (KPS) greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu) Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations Ability to understand and the willingness to provide informed consent. Exclusion Criteria: Cannot receive furosemide Allergy to sulfa or sulfa-containing medications History of Stevens-Johnson syndrome Known Paget's disease 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 |
| --- | --- | --- |
| Diagnostic accuracy of 68Ga PSMA PET scans for detection of regional pelvic nodal metastases | Sensitivity, specificity, positive, and negative predictive value of 68Ga PSMA PET scan for regional pelvic nodal metastases using pathological results from the prostatecomy | Within 3 months of prostectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of 68Ga PSMA PET scans for detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases. | Sensitivity, specificity, positive, and negative predictive value of 68Ga PSMA PET scan using biopsy results, imaging, and clinical follow-up information. | at 3 and 12 months post-prostatecomy | 

 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