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Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer (ChoPEN)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Sridhar P Susheela, Bangalore Institute of Oncology.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Bangalore Institute of Oncology
Information provided by (Responsible Party):
Sridhar P Susheela, Bangalore Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01769950
First received: January 10, 2013
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
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 | Intervention |
|---|---|
| Prostate Cancer | Other: Choline-PET |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
U.S. FDA Resources
Further study details as provided by Sridhar P Susheela, Bangalore Institute of Oncology:
Primary Outcome Measures:
- 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:
- 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.
- 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:
- 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.
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769950
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769950
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
| 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 |
| Study First Received: | January 10, 2013 |
| Last Updated: | January 15, 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 |
ClinicalTrials.gov processed this record on June 23, 2017