ChoPEN: Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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:
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Outcome Measures
Primary Outcome Measures
- Detection of Choline-PET detected nodal metastases [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
- Comparison of Choline-PET and CT for the detection of nodal metastatic disease [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.
- Comparison of Choline-PET and MRI for the detection of nodal metastatic disease [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
- Detection of extra-pelvic non-nodal metastases [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
Criteria
Inclusion Criteria:
-
Consenting patients
-
Diagnosed prostate cancer
Exclusion Criteria:
- Metastatic disease at presentation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HealthCare Global- Bangalore Institute of Oncology | Bengaluru | Karnataka | India | 560027 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Choline-Prostate-1