F-18 Sodium Fluoride in Prostate Cancer

NCT01240551 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 11002111-C-0021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Neoplasm

Keywords

Imaging; Bone Metastasis; Bone Scan; Radiopharmaceutical; Pet Scan; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Present or Not Present Bone Metastasis

  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.

  Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  date treatment consent signed to date off study, approximately 52.5 months

Study Arms (2)

Mets via NaF-18 PET/CT

ACTIVE COMPARATOR

Patients with known bone metastases (i.e. mets).

Drug: F-18 NaF

No-Mets via NaF-18 PET/CT

ACTIVE COMPARATOR

Patients with no clinical evidence of bone metastases

Drug: F-18 NaF

Interventions

F-18 NaF DRUG

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.

Mets via NaF-18 PET/CT; No-Mets via NaF-18 PET/CT

Eligibility Criteria

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

You may qualify if:

• 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)
• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487.

  PMID: 18309951 BACKGROUND

• Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.

  PMID: 15470213 BACKGROUND

• Grant FD, Fahey FH, Packard AB, Davis RT, Alavi A, Treves ST. Skeletal PET with 18F-fluoride: applying new technology to an old tracer. J Nucl Med. 2008 Jan;49(1):68-78. doi: 10.2967/jnumed.106.037200. Epub 2007 Dec 12.

  PMID: 18077529 BACKGROUND

• Kurdziel KA, Shih JH, Apolo AB, Lindenberg L, Mena E, McKinney YY, Adler SS, Turkbey B, Dahut W, Gulley JL, Madan RA, Landgren O, Choyke PL. The kinetics and reproducibility of 18F-sodium fluoride for oncology using current PET camera technology. J Nucl Med. 2012 Aug;53(8):1175-84. doi: 10.2967/jnumed.111.100883. Epub 2012 Jun 22.

  PMID: 22728263 RESULT

Related Links

• NIH Clinical Center Detailed Web Page

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

Results Point of Contact

• Title: Dr. Karen Kurdziel
• Organization: National Cancer Institute

kurdziek@mail.nih.gov

301-443-0622

Study Officials

• Karen A Kurdziel, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2010
• First Posted: November 15, 2010
• Study Start: November 30, 2010
• Primary Completion: May 31, 2013
• Study Completion: May 31, 2013
• Last Updated: November 6, 2017
• Results First Posted: December 24, 2014

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)