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

Bangalore Institute of Oncology

Status: Unknown

Conditions: Prostate Cancer

Treatments: Other: Choline-PET

Study type: Interventional

Funder types: Other

Identifiers

NCT01769950

Choline-Prostate-1

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consenting patients
• Diagnosed prostate cancer

Exclusion criteria

• Metastatic disease at presentation

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Choline-PET arm

Experimental group

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.

Treatment:

Other: Choline-PET