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Clinical Application of 68Ga-PSMA PET in Prostate Cancer

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National Taiwan University

Status

Unknown

Conditions

Prostate Cancer

Treatments

Diagnostic Test: Ga-68 PSMA PET

Study type

Observational

Funder types

Other

Identifiers

NCT03650946
201508052MIND

Details and patient eligibility

About

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.

Full description

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.

Enrollment

150 estimated patients

Sex

Male

Ages

40 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

1
Description:
men with high or intermediate risk localized disease who are about to undergo definitive surgery or radiotherapy
Treatment:
Diagnostic Test: Ga-68 PSMA PET
2
Description:
men with rising PSA after local definitive treatments
Treatment:
Diagnostic Test: Ga-68 PSMA PET
3
Description:
m0CRPC with a PSA \>1.0 or 2.0
Treatment:
Diagnostic Test: Ga-68 PSMA PET

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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