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

NCT01769950 | Unknown DMC

• 1 other identifier: Choline-Prostate-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Detection of Choline-PET detected nodal metastases

  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.

  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 (2)

• 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

• 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

Other Outcomes (1)

• 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

Study Arms (1)

Choline-PET arm

EXPERIMENTAL

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

Interventions

Choline-PET OTHER

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.

Also known as: Choline PET-CT, Choline PET/CT, Carbon-11 Choline PET, Fluorine-18 Choline PET

Choline-PET arm

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting patients
• Diagnosed prostate cancer

You may not qualify if:

• Metastatic disease at presentation

Sponsors & Collaborators

• Bangalore Institute of Oncology: lead

Study Sites (1)

HealthCare Global- Bangalore Institute of Oncology

Bengaluru, Karnataka, 560027, India

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ajaikumar Basavalingaiah, MD

  HealthCare Global- Bangalore Insititute of Oncology

  STUDY CHAIR

• 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 DIRECTOR

Central Study Contacts

Sridhar P Susheela, MD, DNB

CONTACT

9008482284; sridhar1973@ymail.com

Swaroop Revannasiddaiah, MD

CONTACT

8971862565; swarooptheone@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 17, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

IN (1)