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F-18 Sodium Fluoride in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01240551
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : December 24, 2014
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Karen Kurdziel, M.D., National Institutes of Health Clinical Center (CC)

Study Description
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Brief Summary:

Background:

- Sodium fluoride (NaF) is a common compound that is found in various foods and can be used to increase bone strength. When this compound is added to a small dose of radiation (F-18), it collects in the bones, with higher amounts in areas where the bone is rapidly changing, such as the site of a healing fracture or a tumor. By giving F-18 NaF before a combined positron emission tomography/ computed tomography (PET/CT) scan, researchers hope to be able to better measure the changes in the bone that may indicate that a certain type of cancer (such as prostate cancer) has spread to the bones.

Objectives:

  • To evaluate the effectiveness of F-18 NaF in imaging studies to measure bone tumors and their change over time and compare with clinical course, in individuals with prostate cancer.
  • To determine the smallest amount of change in the bone tumors that F-18 NaF can accurately measure.

Eligibility:

- Men at least 18 years of age who have been diagnosed with prostate cancer and have had imaging studies to determine whether the cancer has spread to their bones. Both patients with and without known bone involvement will be enrolled.

Design:

  • Participants will be screened with a physical examination, medical history, and imaging studies, and will provide baseline blood samples to evaluate kidney function.
  • For the study, participants will have two F-18 NaF PET/CT scans on separate days for baseline. These repeat scans will be used to determine the amount of change that is due to the imaging process alone (i.e. not due to the disease getting better or worse. Participants will receive a dose of F-18 NaF intravenously, and will have PET/CT scanning over the body (mid ear to upper thighs) over 1 hour, the body followed by a complete whole-body PET/CT scan at approximately 2 hours after F-18 NaF injection. Participants will be watched closely for side effects from the F-18 NaF until the scans are done, and will be asked to drink plenty of water to void the F-18 NaF from the body after the scans.
  • As a followup study, participants will have two more F-18 NaF PET/CT scans, one 4 to 8 months after the first scans and then one 10 to 14 months after the first scans. Participants will provide additional blood samples before the followup scans.

Condition or disease Intervention/treatment Phase
Prostate Neoplasm Drug: F-18 NaF Phase 2

Detailed Description:

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 (methylene diphosphonate) 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 (prostate specific antigen) 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 (Eastern Cooperative Oncology Group) 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of F-18 Sodium Fluoride PET/CT for Metastatic Burden Qualification in Prostate Cancer
Actual Study Start Date : November 30, 2010
Actual Primary Completion Date : May 31, 2013
Actual Study Completion Date : May 31, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Mets via NaF-18 PET/CT
Patients with known bone metastases (i.e. mets).
 Drug: F-18 NaF
All participants will undergo a static F-18 NaF PET/CT 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.
Active Comparator: No-Mets via NaF-18 PET/CT
Patients with no clinical evidence of bone metastases
 Drug: F-18 NaF
All participants will undergo a static F-18 NaF PET/CT 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Present or Not Present Bone Metastasis [ Time Frame: Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument. ]
    Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: date treatment consent signed to date off study, approximately 52.5 months ]
    Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Participants must have a clinical course consistent with prostate cancer and have available documentation of prostate adenocarcinoma from either the National Cancer Institute (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.

EXCLUSION 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240551


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Karen A Kurdziel, M.D. National Cancer Institute (NCI)
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Karen Kurdziel, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01240551    
Other Study ID Numbers: 110021
11-C-0021
First Posted: November 15, 2010    Key Record Dates
Results First Posted: December 24, 2014
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized patient images and associated Prostate Specific-Antigen (PSA) and Gleason Scores.
Time Frame: Indeterminate. Following completion of data analysis de-identified images, PSA and Gleason Scores will be made available on the Cancer Imaging Program's "The Cancer Imaging Archive (TCIA)".
Access Criteria: Open to public.
URL: https://wiki.nci.nih.gov/pages/viewpage.action?pageId=39291472

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Kurdziel, M.D., National Institutes of Health Clinical Center (CC):
Imaging
Bone Metastasis
Bone Scan
 Radiopharmaceutical
Pet Scan
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases