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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01089881
First received: March 17, 2010
Last updated: March 18, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effectiveness of 18F-fluorocholine PET in Detecting, Staging and Following-up Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 150
Study Start Date: January 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
patients with BPH
Group 2
patients with newly diagnosed prostate cancer
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   35 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  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.
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089881

Contacts
Contact: Yu-Hong Jeng, M.D. 886-2-23123456 ext 62134 Yhj5251@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei,, Taiwan, 10043
Contact: Yu-Hong Jeng, M.D.     886-2-23123456 ext 62134     Yhj5251@ntu.edu.tw    
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yu Hong Jeng, M.D National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Hong-Jeng Yu, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01089881     History of Changes
Other Study ID Numbers: 200706006M
Study First Received: March 17, 2010
Last Updated: March 18, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
prostate cancer
18F-fluorocholine
PET
recurrence
metastases

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013