Clinical Application of 68Ga-PSMA PET in Prostate Cancer

Study Overview
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Brief Summary
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Prostate cancer is the 7th leading cause of cancer death for men in Taiwan. It is important to identify the extent of disease extent to deliver adequate treatment, either for primary staging or in recurrence. However, conventional imaging techniques including computed tomography, bone scintigraphy, and immunoscintigraphy with 111In-capromab pendetide are not sensitive or specific enough to detect metastatic or recurrent disease. Although more widely applied, magnetic resonance still relies on size and shape criteria. 68Ga-PSMA is a new novel positron emission radiotracer which several preliminary data has shown to be effective of detecting recurrent or metastatic prostate cancer. These studies are confined to a small retrospective European population. In this study we aim to synthesize the novel tracer, find the usefulness of 68Ga-PSMA PET in detecting prostate cancer, including primary staging and recurrence, explore the relationship between imaging and clinical parameters, and seek the possibility of 68Ga-PSMA PET to predict tumor nature and prognosis.

Detailed Description
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Prostate cancer is the 7th leading cause of cancer death for men in Taiwan. It is important to identify the extent of disease extent to deliver adequate treatment, either for primary staging or in recurrence. However, conventional imaging techniques including computed tomography, bone scintigraphy, and immunoscintigraphy with 111In-capromab pendetide are not sensitive or specific enough to detect metastatic or recurrent disease. Although more widely applied, magnetic resonance still relies on size and shape criteria. 68Ga-PSMA is a new novel positron emission radiotracer which several preliminary data has shown to be effective of detecting recurrent or metastatic prostate cancer. These studies are confined to a small retrospective European population. In this study we aim to synthesize the novel tracer, find the usefulness of 68Ga-PSMA PET in detecting prostate cancer, including primary staging and recurrence, explore the relationship between imaging and clinical parameters, and seek the possibility of 68Ga-PSMA PET to predict tumor nature and prognosis.

Official Title
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Clinical Application of 68Ga-PSMA PET in Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Ga-68 PSMA PET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed prostate cancer Exclusion Criteria: Patients with known malignancy in other organs. Patients with severe claustrophobia or unstable vital sigh Other serious comorbidities evaluated by primary investigator

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 99 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>men with high or intermediate risk localized disease who are about to undergo definitive surgery or radiotherapy | Diagnostic Test: Ga-68 PSMA PET<br>* Ga-68 PSMA PET<br>|
| 2<br>men with rising PSA after local definitive treatments | Diagnostic Test: Ga-68 PSMA PET<br>* Ga-68 PSMA PET<br>|
| 3<br>m0CRPC with a PSA >1.0 or 2.0 | Diagnostic Test: Ga-68 PSMA PET<br>* Ga-68 PSMA PET<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | initial staging compared to pathology, clinical and follow-up result | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Ga-68 PSMA PET