Clinical Application of 68Ga-PSMA PET in Prostate Cancer

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: Ga-68 PSMA PET

• Registration Number: NCT03650946
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-05
• Study Start: 2018-08
• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-08-27
• Last Update Submitted: 2018-08-27
• Study First Posted: 2018-08-29
• Last Update Posted: 2018-08-29
• Primary Completion: 2019-07
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

• Histologically confirmed prostate cancer

Read More

Exclusion Criteria

• Patients with known malignancy in other organs.
• Patients with severe claustrophobia or unstable vital sigh
• Other serious comorbidities evaluated by primary investigator

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	1 year	initial staging compared to pathology, clinical and follow-up result

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan