Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer (ChoPEN)
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Choline-PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Choline PET, Choline PET-CT, Positron emission tomography, Prostate cancer
Eligibility Criteria
Inclusion Criteria:
- Consenting patients
- Diagnosed prostate cancer
Exclusion Criteria:
- Metastatic disease at presentation
Sites / Locations
- HealthCare Global- Bangalore Institute of OncologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Choline-PET arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01769950
First Posted
January 10, 2013
Last Updated
January 15, 2013
Sponsor
Bangalore Institute of Oncology
1. Study Identification
Unique Protocol Identification Number
NCT01769950
Brief Title
Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangalore Institute of Oncology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Choline PET, Choline PET-CT, Positron emission tomography, Prostate cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Choline-PET arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Choline-PET
Other Intervention Name(s)
Choline PET-CT, Choline PET/CT, Carbon-11 Choline PET, Fluorine-18 Choline PET
Intervention Description
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.
Primary Outcome Measure Information:
Title
Detection of Choline-PET detected nodal metastases
Description
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.
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
Secondary Outcome Measure Information:
Title
Comparison of Choline-PET and CT for the detection of nodal metastatic disease
Description
For each enrolled patient, the information regarding nodal metastatic disease gained from Choline-PET scan will be compared with CT scan data.
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
Title
Comparison of Choline-PET and MRI for the detection of nodal metastatic disease
Description
For each enrolled patient, the information regarding nodal metastatic disease gained from Choline-PET scan will be compared with MRI scan data.
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
Other Pre-specified Outcome Measures:
Title
Detection of extra-pelvic non-nodal metastases
Description
Evidence of extra-pelvic non-nodal metastases detected by Choline-PET scan will be recorded.
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
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consenting patients
Diagnosed prostate cancer
Exclusion Criteria:
Metastatic disease at presentation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sridhar P Susheela, MD, DNB
Phone
9008482284
Ext
91
Email
sridhar1973@ymail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Swaroop Revannasiddaiah, MD
Phone
8971862565
Ext
91
Email
swarooptheone@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajaikumar Basavalingaiah, MD
Organizational Affiliation
HealthCare Global- Bangalore Insititute of Oncology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kumar G Kallur, MD
Organizational Affiliation
HealthCare Global- Bangalore Institute of Oncology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Swaroop Revannasiddaiah, MD
Organizational Affiliation
HealthCare Global- Bangalore Institute of Oncology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sandeep Muzumder, MD
Organizational Affiliation
HealthCare Global- Bangalore Institute of Oncology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Govindarajan Mallarajapatna, MD
Organizational Affiliation
HealthCare Global- Bangalore Institute of Oncology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Raghunath S Krishnappa, MS, DNB
Organizational Affiliation
HealthCare Global- Bangalore Institute of Oncology
Official's Role
Study Director
Facility Information:
Facility Name
HealthCare Global- Bangalore Institute of Oncology
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Swaroop Revannasiddaiah, MD
Phone
8971862565
Ext
91
Email
swarooptheone@gmail.com
First Name & Middle Initial & Last Name & Degree
Sridhar P Susheela, MD
Phone
9008482284
Ext
91
Email
sridhar1973@ymail.com
12. IPD Sharing Statement
Learn more about this trial
Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer
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