68 Ga-PSMA for High Risk Prostate Cancer

Study Overview
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Brief Summary
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This is a prospective, single-center, open-label pilot study of 68GA-PSMA-11 given at a single time prior to PET/CT imaging in men with localized high risk prostate cancer or biochemical recurrence. The imaging agent (68 Ga-PSMA 11 will be administered on an outpatient basis. It will be administered prior to the PET/CT imaging. The objective is to evaluate the distribution of 68GA-PSMA-11 in tissues and to determine if this alters the planned clinical management.

Detailed Description
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This is a prospective, open label, single-center, single-arm, pilot diagnostic accuracy study to evaluate the tissue distribution of 68Ga-PSMA Positron Emission Tomography (PET)/CT in 80 patients with high risk localized prostate cancer or biochemical recurrence. Subjects will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection. All patients will be closely monitored with vital signs (blood pressure and heart rate), before and 2 hours following radiotracer administration. Patients will receive a phone call 2 days following PET/CT to assess for adverse events. To minimize bias, all PET/CT images will be interpreted by a board-certified radiologist. The radiologist evaluating the images will be blinded to the final outcome, such as the histopathology of any biopsies and the outcome of subsequent imaging. Patients with study-defined high-risk features who are eligible and scheduled for radical prostatectomy will undergo 68Ga-PSMA-11 PET/CT injection. The results of the 68Ga-PSMA-11 PET/CT may alter patient management in one of several ways, including the decision to not pursue surgical extirpation (e.g. in the event of extensive distant metastasis) in favor of systemic therapy. It is also possible that the extent of surgical resection may be altered, such as non-regional pelvic or retroperitoneal lymph node dissection. The alteration in planned surgical treatment from standard of care will be recorded as a secondary-end point.

Official Title
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Comparison of 68 Ga-PSMA Positron Emission Tomography (PET)/CT to Conventional Imaging in Men With High Risk Prostate Cancer

Conditions
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Prostate Cancer, High Risk

Intervention / Treatment
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* Drug: 68Ga-PSMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male aged 21 years or older Ability to understand and provide written informed consent All patients must have histopathological proven adenocarcinoma of the prostate ECOG performance status 0-1 No evidence of other malignancy (except squamous or basal cell skin cancers) Consent to use acceptable form of birth control following the imaging period (condoms for a period of seven days after injection if sexually active) A. Inclusion criteria specific for the pre-prostatectomy group: Untreated prostate Cancer with high-risk features, as defined as having at least one of the following criteria: i. PSA ≥ 20.0 ng/mL ii. ISUP Gleason Grade Group 3, 4 or 5 iii. Clinical stage T3 B. Inclusion criteria specific for biochemical recurrence: (i) Histopathological proven prostate adenocarcinoma (ii)Rising PSA after definitive therapy with prostatectomy or radiation (therapy (external beam or brachytherapy). Post radical prostatectomy (RP), PSA greater than or equal to 0.2 ng/ml measured more than 6 weeks after RP. Post-radiation therapy, PSA that is equal to or greater than 2 ng/ml rise above PSA nadir Exclusion Criteria: Unable to tolerate a PET/CT (e.g. unable to lie flat) Recent history of a secondary malignancy in the past year, excluding non-melanoma skin cancer (non-metastatic) Known allergic reactions to 68-Ga, or gadolinium-based contrast agents. Treatment with another investigational drug or other intervention 2 years. Patient has any medical, psychological or social condition that, in opinion of the investigator will make difficult for the participant to tolerate study intervention.

Ages Eligible for Study
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Minimum Age: 21 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
Interventional Model Description: All subjects will receive the Investigational Product.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68 Ga PSMA<br>Comparison between the results of 68 Ga-PSMA PET/CT to conventional imaging (bone scan, CT) in men with high risk prostate cancer. | Drug: 68Ga-PSMA<br>* All subjects enrolled in the study will receive a single IV dose of 3-7 mCi of 68 Ga-PSMA (study drug) followed by PET/CT imaging for detection of tumor location.<br>* Other names: 68 Ga-PSMA 11;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Lymph Node Involvement | Number of patients with cTxNoMo (clinically localized disease) found on final histological examination to have lymph node involvement as determined by 68GA-PSMA-11 PET/CT. | 18 months | 
| Proportion of Patients Which Clinical Management Was Altered | Number of patients in which 68GA-PSMA-11 PET/CT altered the planned clinical management. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness | Uptake intensity detected on PET/CT in the prostate and outside of the prostate | 18 months | 
| Number of Patients With Suspicious Lesions | Number of patients in which 68Ga-PSMA 11 PET/CT showed suspicious lesions that are were not seen in standard diagnostic modalities of bone scan, CTs or MRI. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSMA, 68 Ga