Clinical trial NCT01769950: Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer
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
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Choline PET
Choline PET-CT
Positron emission tomography
Prostate cancer
Lead sponsor: Bangalore Institute of Oncology
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 120
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: Inclusion Criteria:

* Consenting patients
* Diagnosed prostate cancer

Exclusion Criteria:

* Metastatic disease at presentation

Primary outcomes:
measure: Detection of Choline-PET detected nodal metastases
timeFrame: 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 outcomes:
measure: Comparison of Choline-PET and CT for the detection of nodal metastatic disease
timeFrame: 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
measure: Comparison of Choline-PET and MRI for the detection of nodal metastatic disease
timeFrame: 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 outcomes:
measure: Detection of extra-pelvic non-nodal metastases
timeFrame: 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
Locations:
city: Bengaluru
country: India
facility: HealthCare Global- Bangalore Institute of Oncology
state: Karnataka
Study officials:
affiliation: HealthCare Global- Bangalore Insititute of Oncology
name: Ajaikumar Basavalingaiah, MD
role: STUDY_CHAIR
affiliation: HealthCare Global- Bangalore Institute of Oncology
name: Kumar G Kallur, MD
role: STUDY_DIRECTOR
affiliation: HealthCare Global- Bangalore Institute of Oncology
name: Swaroop Revannasiddaiah, MD
role: STUDY_DIRECTOR
affiliation: HealthCare Global- Bangalore Institute of Oncology
name: Sandeep Muzumder, MD
role: STUDY_DIRECTOR
affiliation: HealthCare Global- Bangalore Institute of Oncology
name: Govindarajan Mallarajapatna, MD
role: STUDY_DIRECTOR
affiliation: HealthCare Global- Bangalore Institute of Oncology
name: Raghunath S Krishnappa, MS, DNB
role: STUDY_DIRECTOR
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