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 currently recruiting participants.
Verified December 2013 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01967862
First received: October 18, 2013
Last updated: December 18, 2013
Last verified: December 2013
  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) works in finding metastases in patients with recurrent prostate cancer. Diagnostic procedures, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI, may help find and diagnose metastatic prostate cancer. It is not yet known whether standard CT and bone scan is more effective than fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI in diagnosing metastatic prostate cancer.


Condition Intervention Phase
Recurrent Prostate Cancer
Stage IV 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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Presence of metastatic disease detected using WB/axial MRI and/or fluorine F 18 sodium fluoride PET/CT [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Ability of WB MRI to identify sites of disease [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
  • Relative contribution of fluorine F 18 sodium fluoride PET/CT [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
  • Relative contribution of MRI [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: December 2013
Estimated Primary Completion Date: December 2016 (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 6-year predicted 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.

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
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of prior radical prostatectomy for prostate cancer
  • Two consecutive increases of PSA and an absolute PSA value of >= 2.0 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 progression not verified by sequential rising 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01967862

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Przemyslaw W. Twardowski    800-826-4673    ptwardowski@coh.org   
Principal Investigator: Przemyslaw W. Twardowski         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Przemyslaw Twardowski City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01967862     History of Changes
Other Study ID Numbers: 13365, NCI-2013-01924, 13365, P30CA033572
Study First Received: October 18, 2013
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Neoplasm Metastasis
Prostatic Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014