Clinical Application of 68Ga-PSMA PET in Prostate Cancer

NCT ID: NCT03650946

Last Updated: 2018-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-31

Study Completion Date

2021-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

men with high or intermediate risk localized disease who are about to undergo definitive surgery or radiotherapy

Ga-68 PSMA PET

Intervention Type DIAGNOSTIC_TEST

Ga-68 PSMA PET

2

men with rising PSA after local definitive treatments

Ga-68 PSMA PET

Intervention Type DIAGNOSTIC_TEST

Ga-68 PSMA PET

3

m0CRPC with a PSA \>1.0 or 2.0

Ga-68 PSMA PET

Intervention Type DIAGNOSTIC_TEST

Ga-68 PSMA PET

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ga-68 PSMA PET

Ga-68 PSMA PET

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ching Chu Lu

Role: primary

+886-2-23123456 ext. 65477

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201508052MIND

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

68 Ga-PSMA for High Risk Prostate Cancer
NCT04614363 COMPLETED PHASE1/PHASE2
Ga-68-PSMA-11 in High-risk Prostate Cancer
NCT03362359 COMPLETED PHASE1/PHASE2
68Ga-XACP3 PET/CT in Prostate Cancer
NCT07242014 RECRUITING NA