Clinical Application of 68Ga-PSMA PET in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Clinical Application of 68Ga-PSMA PET in Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03650946
• Other study ID #: 201508052MIND
• Status: Recruiting
• Start date: August 2018
• Est. completion date: July 30, 2021

Study information

• Verified date: May 2018
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 30, 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Ga-68 PSMA PET
Ga-68 PSMA PET

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	initial staging compared to pathology, clinical and follow-up result	1 year