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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Bangalore Institute of Oncology
Sponsor:
Information provided by (Responsible Party):
Sridhar P Susheela, Bangalore Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01769950
First received: January 10, 2013
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention
Prostate Cancer
Other: Choline-PET

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Bangalore Institute of Oncology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    For each enrolled patient, the information regarding nodal metastatic disease gained from Choline-PET scan will be compared with CT scan data.

  • 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 ] [ Designated as safety issue: No ]
    For each enrolled patient, the information regarding nodal metastatic disease gained from Choline-PET scan will be compared with MRI scan data.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Evidence of extra-pelvic non-nodal metastases detected by Choline-PET scan will be recorded.


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consenting patients
  • Diagnosed prostate cancer

Exclusion Criteria:

  • Metastatic disease at presentation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769950

Contacts
Contact: Sridhar P Susheela, MD, DNB 9008482284 ext 91 sridhar1973@ymail.com
Contact: Swaroop Revannasiddaiah, MD 8971862565 ext 91 swarooptheone@gmail.com

Locations
India
HealthCare Global- Bangalore Institute of Oncology Recruiting
Bengaluru, Karnataka, India, 560027
Contact: Swaroop Revannasiddaiah, MD    8971862565 ext 91    swarooptheone@gmail.com   
Contact: Sridhar P Susheela, MD    9008482284 ext 91    sridhar1973@ymail.com   
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Sridhar P Susheela, Principal Investigator, Bangalore Institute of Oncology
ClinicalTrials.gov Identifier: NCT01769950     History of Changes
Other Study ID Numbers: Choline-Prostate-1
Study First Received: January 10, 2013
Last Updated: January 15, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Bangalore Institute of Oncology:
Choline PET
Choline PET-CT
Positron emission tomography
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014