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

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Other: Choline-PET	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
Intervention Model:	Single Group Assignment
Masking:	None (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.
Study Start Date :	January 2013
Estimated Primary Completion Date :	January 2014
Estimated Study Completion Date :	February 2014

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.
2. 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.

Other Outcome Measures:

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes 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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	January 17, 2013
Last Update Posted:	January 17, 2013
Last Verified:	January 2013

Keywords provided by Sridhar P Susheela, 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; Gastrointestinal Agents; Lipid Regulating Agents; Nootropic Agents