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Clinical Trials/NCT01769950
NCT01769950
Unknown
Not Applicable

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

Bangalore Institute of Oncology1 site in 1 country120 target enrollmentJanuary 2013
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Bangalore Institute of Oncology
Enrollment
120
Locations
1
Primary Endpoint
Detection of Choline-PET detected nodal metastases
Last Updated
13 years ago

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
February 2014
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Bangalore Institute of Oncology
Responsible Party
Principal Investigator
Principal Investigator

Sridhar P Susheela

Principal Investigator

Bangalore Institute of Oncology

Eligibility Criteria

Inclusion Criteria

  • Consenting patients
  • Diagnosed prostate cancer

Exclusion Criteria

  • Metastatic disease at presentation

Outcomes

Primary Outcomes

Detection of Choline-PET detected nodal metastases

Time Frame: 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

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.

Secondary Outcomes

  • Comparison of Choline-PET and MRI for the detection of nodal metastatic disease(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)
  • Comparison of Choline-PET and CT for the detection of nodal metastatic disease(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)

Study Sites (1)

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