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

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

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

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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. 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.

Detailed Description

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Background:

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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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

Group 1: 50 patients with BPH

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

* Patients with other known malignancies will be excluded.
Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Hong Jeng, M.D.

Role: CONTACT

886-2-23123456 ext. 62134

Facility Contacts

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Yu-Hong Jeng, M.D.

Role: primary

886-2-23123456 ext. 62134

Other Identifiers

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200706006M

Identifier Type: -

Identifier Source: org_study_id

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