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

Evaluation of the Incidence of Choline-PET Detected Nodal Metastases Among Newly Diagnosed Prostate Cancer Patients With Presumed Absence of Nodal and Distant Metastases.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01769950
Acronym
ChoPEN
Enrollment
120
Registered
2013-01-17
Start date
2013-01-31
Completion date
2014-02-28
Last updated
2013-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Choline PET, Choline PET-CT, Positron emission tomography, Prostate cancer

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).

Interventions

OTHERCholine-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.

Sponsors

Bangalore Institute of Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion criteria

* Consenting patients * Diagnosed prostate cancer

Exclusion criteria

* Metastatic disease at presentation

Design outcomes

Primary

MeasureTime frameDescription
Detection of Choline-PET detected nodal metastasesEligible 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 diagnosisAt 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

MeasureTime frameDescription
Comparison of Choline-PET and CT for the detection of nodal metastatic diseaseEligible 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 diagnosisFor 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 diseaseEligible 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 diagnosisFor each enrolled patient, the information regarding nodal metastatic disease gained from Choline-PET scan will be compared with MRI scan data.

Other

MeasureTime frameDescription
Detection of extra-pelvic non-nodal metastasesEligible 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 diagnosisEvidence of extra-pelvic non-nodal metastases detected by Choline-PET scan will be recorded.

Countries

India

Contacts

Primary ContactSridhar P Susheela, MD, DNB
sridhar1973@ymail.com9008482284
Backup ContactSwaroop Revannasiddaiah, MD
swarooptheone@gmail.com8971862565

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026