Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer

Prostate Cancer Clinical Trial

— ChoPEN  

Official title:

Evaluation of the Incidence of Choline-PET Detected Nodal Metastases Among Newly Diagnosed Prostate Cancer Patients With Presumed Absence of Nodal and Distant Metastases.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01769950
• Other study ID #: Choline-Prostate-1
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2013
• Last updated: January 15, 2013
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2013
• Source: Bangalore Institute of Oncology
• Contact: Sridhar P Susheela, MD, DNB
• Phone: 9008482284
• Email: sridhar1973[@]ymail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Nodal involvement among patients with prostate cancer is known to be a poor prognostic factor. Traditionally, the presence or absence of nodal disease in patients with prostate cancer is ascertained with the use of anatomical imaging methods such as computed tomography (CT) and magnetic resonance imaging (MRI).

However, the sensitivities of CT and MRI for the detection of pelvic nodal disease is rather low, with reports placing the value to lie between 50-80%.

Positron emission tomography (PET) with the use of carbon-11 or fluorine-18 tagged choline (Choline-PET) is an approach which is known to deliver a high sensitivity for the imaging of prostate cancer disease burden in the primary, nodal and the metastatic areas.

The investigators in this prospective trial intend to utilize Choline-PET among all newly diagnosed patients of prostate cancer who are presumed to be non-N1 (absence of nodal disease on conventional imaging) and non-M1 (absence of metastatic disease on conventional imaging).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Consenting patients

• Diagnosed prostate cancer

Exclusion Criteria:

• Metastatic disease at presentation

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Choline-PET
Carbon-11 or Fluorine-18 PET-CT will be acquired with a scanner with integrated PET and CT scanning ability at the time of diagnosis. It must be however noted that Choline-PET will not be considered as an alternative to magnetic resonance imaging (MRI). In fact, all patients will undergo MRI too.

Locations

Country	Name	City	State
India	HealthCare Global- Bangalore Institute of Oncology	Bengaluru	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Bangalore Institute of Oncology

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Detection of extra-pelvic non-nodal metastases	Evidence of extra-pelvic non-nodal metastases detected by Choline-PET scan will be recorded.	Eligible participants will undergo a Choline-PET scan before the initiation of any cancer specific treatments, that is within a time frame of one week from the time of diagnosis	No
Primary	Detection of Choline-PET detected nodal metastases	At the time of diagnosis of prostate cancer, the investigators intend to utilize Choline-PET scan to gain evidence of nodal metastatic disease with a motive to assess for a potentially higher sensitivity than with the use of conventional imaging methods such as CT or MRI.	Eligible participants will undergo a Choline-PET scan before the initiation of any cancer specific treatments, that is within a time frame of one week from the time of diagnosis	No
Secondary	Comparison of Choline-PET and CT for the detection of nodal metastatic disease	For each enrolled patient, the information regarding nodal metastatic disease gained from Choline-PET scan will be compared with CT scan data.	Eligible participants will undergo a Choline-PET scan before the initiation of any cancer specific treatments, that is within a time frame of one week from the time of diagnosis	No
Secondary	Comparison of Choline-PET and MRI for the detection of nodal metastatic disease	For each enrolled patient, the information regarding nodal metastatic disease gained from Choline-PET scan will be compared with MRI scan data.	Eligible participants will undergo a Choline-PET scan before the initiation of any cancer specific treatments, that is within a time frame of one week from the time of diagnosis	No