The Effectiveness of 18F-fluorocholine Positron Emission Tomography (PET) in Detecting, Staging and Following-up Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

The Effectiveness of 18F-fluorocholine PET in Detecting, Staging and Following-up Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01089881
• Other study ID #: 200706006M
• Status: Recruiting
• Phase: N/A
• First received: March 17, 2010
• Last updated: March 18, 2010
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: National Taiwan University Hospital
• Contact: Yu-Hong Jeng, M.D.
• Phone: 886-2-23123456
• Email: Yhj5251[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

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,