Clinical trial NCT01089881: The Effectiveness of 18F-fluorocholine Positron Emission Tomography (PET) in Detecting, Staging and Following-up Prostate Cancer
Official title: The Effectiveness of 18F-fluorocholine PET in Detecting, Staging and Following-up Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: prostate cancer
18F-fluorocholine
PET
recurrence
metastases
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-03-19
Enrollment: 150
Sex: MALE
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei,
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu Hong Jeng, M.D
role: PRINCIPAL_INVESTIGATOR
References: