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F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study


Phase 0
18 Years
N/A
Open (Enrolling)
Male
Bone Metastases, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer

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Trial Information

F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study


PRIMARY OBJECTIVES:

I. To evaluate the sensitivity and specificity of whole-body fluorine F 18 sodium fluoride
PET/CT scan in detecting bone metastases in patients with high-risk prostate cancer using
bone scan as the reference standard.

II. To evaluate the sensitivity and specificity of whole-body MRI in detecting bone
metastases in patients with high-risk prostate cancer using bone scan as the reference
standard.

OUTLINE:

Patients undergo technetium Tc 99m methylene diphosphonate bone scan, fluorine F 18 sodium
fluoride PET/CT scan, and whole-body MRI for the detection of bone metastases. Patients with
discordant imaging results (negative bone scan and positive PET/CT scan and/or MRI) undergo
additional imaging at 6, 12, 18, and 24 months.


Inclusion Criteria:



- Histologically confirmed primary prostate cancer

- At high risk for bone metastases based on rising PSA levels despite
androgen-deprivation therapy, PSA > 10 ng/mL, and/or PSA doubling time of ≤ 10 months

- ECOG performance status 0-1

- No uncontrolled concurrent illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situations that would limit compliance with study
requirements

- No known contraindications to MRI such as presence of MRI-incompatible devices (e.g.,
pacemakers and certain aneurysm clips), severe claustrophobia, or any other condition
that would preclude proximity to a strong magnetic field

- No patients who are unable to tolerate or who have a life-threatening allergy to
technetium Tc 99m methylene diphosphonate or fluorine F 18 sodium fluoride

- At least 7 days since prior and no concurrent other investigational therapeutic
agents

- No other investigational agents for > 7 days after completion of study treatment

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Uptake of fluorine F 18 sodium fluoride on PET/CT scan

Outcome Description:

Determine if increased uptake of 18F-fluoride on PET/CT scan is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard.

Outcome Time Frame:

Up to 24 months

Safety Issue:

No

Principal Investigator

Mukesh Harisinghani

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02972

NCT ID:

NCT00956163

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Bone Metastases
  • Recurrent Prostate Cancer
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114