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Fluorine F 18 Sodium Fluoride PET/CT and Whole Body and Axial MRI in Finding Metastases in Patients With Recurrent Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01967862
First received: October 18, 2013
Last updated: August 21, 2017
Last verified: August 2017
  Purpose
This phase II trial studies how well fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance imaging (MRI) work in finding metastases in patients with recurrent prostate cancer. New imaging techniques, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI, may be more effective than standard CT and bone scan in finding metastatic prostate cancer.

Condition Intervention Phase
Recurrent Prostate Cancer Procedure: computed tomography Procedure: bone scan Procedure: 3-Tesla magnetic resonance imaging Procedure: diffusion-weighted magnetic resonance imaging Radiation: fluorine F 18 sodium fluoride Procedure: positron emission tomography Other: laboratory biomarker analysis Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: F18 NaF PET/CT and Whole Body and Axial MRI for the Detection of Metastases in Patients With Biochemical Recurrence of Prostate Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Percent of patients with negative standard scans and positive on the newer scans [ Time Frame: Up to 6 months ]
    Will be estimated with a 95% confidence interval (CI) half-width of less of 15%.


Secondary Outcome Measures:
  • Percent of eligible patients with negative, indeterminate and positive CT scan/bone scan and targeted X-rays if done [ Time Frame: Up to 6 months ]
    The percent positive for metastatic disease can be estimated with a 95% CI half-width of less than 13%.

  • Proportion of patients with biochemically recurrent PC in whom recurrence in the prostate bed can be visualized using MRI in the absence of detection using CT scan [ Time Frame: Up to 52 weeks ]
  • Presence of metastatic disease detected using WB/axial MRI and/or fluorine F 18 sodium fluoride PET/CT [ Time Frame: Up to 52 weeks ]
    Will be correlated with the predicted 6-year probability of progression-free survival based on the Memorial Sloan Kettering Cancer Center salvage RT PC nomogram, and with PSA level at baseline.

  • Ability of axial MRI to identify sites of disease [ Time Frame: Up to 52 weeks ]
  • Ability of WB MRI to identify sites of disease [ Time Frame: Up to 52 weeks ]
  • Relative contribution of fluorine F 18 sodium fluoride PET/CT [ Time Frame: Up to 52 weeks ]
  • Relative contribution of MRI [ Time Frame: Up to 52 weeks ]

Estimated Enrollment: 56
Study Start Date: December 2013
Estimated Study Completion Date: August 18, 2018
Estimated Primary Completion Date: August 18, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT)
Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.
Procedure: computed tomography
Undergo CT
Other Name: tomography, computed
Procedure: bone scan
Undergo bone scan
Procedure: 3-Tesla magnetic resonance imaging
Undergo axial MRI
Other Names:
  • 3-Tesla MRI
  • 3T MRI
Procedure: diffusion-weighted magnetic resonance imaging
Undergo WB MRI
Other Name: diffusion-weighted MRI
Radiation: fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET/CT
Other Names:
  • 18 F-NaF
  • F-18 NaF
Procedure: computed tomography
Undergo fluorine F 18 sodium fluoride PET/CT
Other Name: tomography, computed
Procedure: positron emission tomography
Undergo fluorine F 18 sodium fluoride PET/CT
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the proportion of patients with biochemically-recurrent prostate cancer (PC) in whom imaging with whole body (WB)/axial MRI and F-18 NaF (fluorine F 18 sodium fluoride) PET/CT results in detection of metastatic disease not visualized on CT scan and bone scan.

SECONDARY OBJECTIVES:

I. To estimate the percent of eligible patients with negative, indeterminate and positive CT scan/bone scan and targeted X-rays if done.

II. To determine the proportion of patients with biochemically-recurrent PC in whom recurrence in the prostate bed can be visualized using MRI in the absence of detection using CT scan.

III. To correlate the presence of metastatic disease detected using WB/axial MRI and/or F-18 NaF PET/CT with the predicted 6-year probability of progression-free survival based on the Memorial Sloan Kettering Cancer Center salvage radiation therapy (RT) PC nomogram, and with prostate-specific antigen (PSA) level at baseline.

IV. To compare the role of axial MRI of the spine to WB/axial MRI with respect to their ability to identify sites of disease. Similarly, to evaluate the relative contribution of F-18 NaF PET and WB/axial MRI.

OUTLINE:

Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.

After completion of study, patients are followed up at 4-6 months and periodically until week 52.

  Eligibility

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

Inclusion Criteria:

  • History of prior radical prostatectomy for prostate cancer
  • Two PSA values >= 0.2 ng/mL at least 4 weeks after prostatectomy
  • Patients who have started radiographic evaluation and underwent CT scan and/or bone scan prior to registration to the study will be able to participate under a late registration provision, provided that the more modern scans (WB/axial MRI and F-18 NaF PET/CT) can be completed within 8 weeks after CT scan and bone scan

Exclusion Criteria:

  • Patients with known metastatic disease
  • PSA recurrence not verified by elevated PSA as discussed in the eligibility section
  • Patients who initiated androgen deprivation therapy or other systemic therapy (chemotherapy, immunotherapy, targeted therapy) for PSA recurrence; nutritional supplements used for treatment of PSA recurrence will be allowed
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967862

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
City of Hope South Pasadean
South Pasadena, California, United States, 91030
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Przemyslaw Twardowski City of Hope Medical Center
  More Information

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01967862     History of Changes
Other Study ID Numbers: 13365
NCI-2013-01924 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
13365 ( Other Identifier: City of Hope Medical Center )
Study First Received: October 18, 2013
Last Updated: August 21, 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 21, 2017