The Effectiveness of 18F-fluorocholine Positron Emission Tomography (PET) in Detecting, Staging and Following-up Prostate Cancer
NCT ID: NCT01089881
Last Updated: 2010-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2008-01-31
2010-12-31
Brief Summary
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Detailed Description
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Prostate cancer is a leading cause of cancer death for male in Taiwan. Although 18F-FDG PET has been shown to be an effective tool in diagnosing many malignancies, previous studies have shown that 18F-FDG is not a suitable PET tracer for detecting prostate cancer. Choline is one of the components of phosphatidylcholine, an essential element of phospholipids in the cell membrane. Some malignant cells show their ability to actively incorporate choline to produce phosphocholine and phosphatidylcholine to facilitate tumor cell duplication. The efficacy of 18F-fluorocholine (18F-FCH) for localizing primary or metastatic prostate cancer has been recently reported in limited studies.
Purpose:
This study will be conducted to delineate the effectiveness of 18F-FCH PET in (1) differentiating benign prostate hypertrophy (BPH) from prostate cancer, (2) staging prostate cancer, (3) following-up patients with prostate cancer after initial curative therapy.
Patients and Methods:
This study will include
1. Group 1: 50 patients with BPH
2. Group 2: 50 patients with newly diagnosed prostate cancer and
3. Group 3: 50 patients who have received curative treatment for prostate cancer and are suspicious of recurrence/metastases because of a persistent increase in their serum PSA.
18F-FCH whole-body PET will be performed for each patient
Expected Results:
To evaluate the effectiveness of 18F-FCH in the diagnosis, staging and follow-up of prostate cancer.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group 1
patients with BPH
No interventions assigned to this group
Group 2
patients with newly diagnosed prostate cancer
No interventions assigned to this group
Group 3
patients who have received curative treatment for prostate cancer and are suspicious of recurrence/metastases because of a persistent increase in their serum PSA.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Age above 35 years old
2. Histologically confirmed BPH
3. Informed consent signed
Group 2: 50 patients with newly diagnosed prostate cancer and
1. Age above 35 years old
2. Histologically confirmed prostate cancer
3. Informed consent signed
Group 3: 50 patients who have
1. Age above 35 years old
2. Histologically confirmed prostate cancer and had received curative treatment for prostate cancer
3. suspicious of recurrence/metastases because of a persistent increase in their serum PSA
4. Informed consent signed
Exclusion Criteria
35 Years
90 Years
MALE
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University Hospital
Principal Investigators
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Yu Hong Jeng, M.D
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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200706006M
Identifier Type: -
Identifier Source: org_study_id
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