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A Pilot Study of F-18 Sodium Fluoride PET/CT for Metastatic Burden Qualification in Prostate Cancer


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Neoplasm

Thank you

Trial Information

A Pilot Study of F-18 Sodium Fluoride PET/CT for Metastatic Burden Qualification in Prostate Cancer


Background:

- Evaluating response to therapy in prostate cancer is limited by the inability to
quantify bony metastatic disease

- F-18 sodium fluoride (NaF) is a PET radiopharmaceutical which localizes in regions of
bony turnover, and was the 1st bone scan agents (prior to Tc-99m MDP availability)

- Today's high sensitivity PET cameras can image the distribution of F-18 NaF as a whole
body volume and permit quantification of uptake over time. The addition of
co-registered CT increases the diagnostic accuracy for detection of metastatic disease

Primary Objective:

-To evaluate the feasibility of using NaF PET/CT to quantitatively measure the extent of
bony metastatic disease in patients with prostate cancer in patients

- To determine the intra-patient reproducibility of F-18 NaF PET/CT

- To explore the relationship between the biodistribution changes in F-18 NaF PET/CT
parameters and the clinical response

Eligibility:

- Participant must have pathology proven adenocarcinoma of the prostate.

- Participant must have

- a history of PSA > 10ng/mL or a history of PSA doubling time of less than or equal
to 6 months, and no known bone metastatic involvement on standard of care imaging
(Tc-99m MDP bone scan, CT etc).

OR

--any PSA level and known bone metastatic disease on standard of care imaging (Tc-99m MDP
bone scan, CT etc.)

- Participant must be 18 years or older and have ECOG Performance grade of 0 to 2

- Ability to provide informed consent. All subjects must sign a document of informed
consent indicating their understanding of the investigational nature and risks of the
study before any protocol related studies are performed.

Design:

This is a pilot, 2-arm, open label study of patients with prostate cancer. One arm will
accrue patients with known bone metastases and the second will accrue patient at risk of
developing bone metastases (30 patients per group; total enrollment 60 patients). As it is
possible that there will be different rates of bone lesion detection dependent on hormone
responsiveness of the tumors, further stratification (castrate sensitive vs. castrate
resistant tumor) may be performed to evaluate for predominant trends. All participants will
undergo a static F-18 NaF imaging session at baseline, at 4-8 months, and at 10-14 months
following enrollment (3 sessions over 1-year). Half of the participants (15 in each group)
will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in
order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over
a 1-year period. The change in bone uptake of F-18 NaF will be measured, reproducibility
determined, and preliminary comparisons with clinical response will be made.

Inclusion Criteria


- INCLUSION CRITERIA:

Participants must have a clinical course consistent with prostate cancer and have
available documentation of prostate adenocarcinoma from either the NCI or from an outside
pathology laboratory.

Participant must have:

- A history of PSA of > 10ng/mL or a history of PSA doubling time of less than or equal to
6 months, and no known bone metastatic involvement on standard of care imaging (Tc-99m MDP
bone scan, CT etc)

OR

- Any PSA level and known bone metastatic disease on standard of care imaging (Tc-99m MDP
bone scan, CT etc).

Ability to provide informed consent. All subjects must sign a document of informed consent
indicating their understanding of the investigational nature and risks of the study before
any protocol related studies are performed.

ECXLUSION CRITERIA:

Participants with severe claustrophobia unresponsive to oral anxiolytics.

Subjects weighing greater than 350 lbs (weight limit for scanner table), or unable to fit
within the imaging gantry.

Subjects with any medical condition or other circumstances that, in the opinion of the
Investigator, would significantly decrease obtaining reliable data, achieving study
objectives or completing the study.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Karen A Kurdziel, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institutes of Health Clinical Center (CC)

Authority:

United States: Federal Government

Study ID:

110021

NCT ID:

NCT01240551

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Prostate Neoplasm
  • Imaging
  • Bone Metastasis
  • Bone Scan
  • Radiopharmaceutical
  • Pet Scan
  • Prostate Cancer
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892