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

January 15, 2013 updated by: Sridhar P Susheela, Bangalore Institute of Oncology

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Karnataka
      • Bengaluru, Karnataka, India, 560027
        • Recruiting
        • HealthCare Global- Bangalore Institute of Oncology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Consenting patients
  • Diagnosed prostate cancer

Exclusion Criteria:

  • Metastatic disease at presentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Choline-PET arm
Every eligible patient will be scanned with Choline-PET at the time of diagnosis of prostate cancer. MRI will also be obtained as it is the current standard of care. CT scan will be obtained as part of the same procedure while procuring the Choline-PET scan with PET-CT dual imaging hardware.
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.
Other Names:
  • Choline PET-CT
  • Choline PET/CT
  • Carbon-11 Choline PET
  • Fluorine-18 Choline PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Choline-PET and CT for the detection of nodal metastatic disease
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
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
Comparison of Choline-PET and MRI for the detection of nodal metastatic disease
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
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of extra-pelvic non-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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangalore Institute of Oncology

Investigators

  • Study Chair: Ajaikumar Basavalingaiah, MD, HealthCare Global- Bangalore Insititute of Oncology
  • Study Director: Kumar G Kallur, MD, HealthCare Global- Bangalore Institute of Oncology
  • Study Director: Swaroop Revannasiddaiah, MD, HealthCare Global- Bangalore Institute of Oncology
  • Study Director: Sandeep Muzumder, MD, HealthCare Global- Bangalore Institute of Oncology
  • Study Director: Govindarajan Mallarajapatna, MD, HealthCare Global- Bangalore Institute of Oncology
  • Study Director: Raghunath S Krishnappa, MS, DNB, HealthCare Global- Bangalore Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

January 10, 2013

First Submitted That Met QC Criteria

January 15, 2013

First Posted (Estimate)

January 17, 2013

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Choline-Prostate-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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