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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

Primary Purpose

Recurrent Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
computed tomography
bone scan
3-Tesla magnetic resonance imaging
diffusion-weighted magnetic resonance imaging
fluorine F 18 sodium fluoride
computed tomography
positron emission tomography
laboratory biomarker analysis
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Recurrent Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center
  • City of Hope South Pasadena

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan.
Count of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease.

Secondary Outcome Measures

Full Information

First Posted
October 18, 2013
Last Updated
August 26, 2020
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01967862
Brief Title
Fluorine F 18 Sodium Fluoride PET/CT and Whole Body and Axial MRI in Finding Metastases in Patients With Recurrent Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
September 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Other Intervention Name(s)
tomography, computed
Intervention Description
Undergo CT
Intervention Type
Procedure
Intervention Name(s)
bone scan
Intervention Description
Undergo bone scan
Intervention Type
Procedure
Intervention Name(s)
3-Tesla magnetic resonance imaging
Other Intervention Name(s)
3-Tesla MRI, 3T MRI
Intervention Description
Undergo axial MRI
Intervention Type
Procedure
Intervention Name(s)
diffusion-weighted magnetic resonance imaging
Other Intervention Name(s)
diffusion-weighted MRI
Intervention Description
Undergo WB MRI
Intervention Type
Radiation
Intervention Name(s)
fluorine F 18 sodium fluoride
Other Intervention Name(s)
18 F-NaF, F-18 NaF
Intervention Description
Undergo fluorine F 18 sodium fluoride PET/CT
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Other Intervention Name(s)
tomography, computed
Intervention Description
Undergo fluorine F 18 sodium fluoride PET/CT
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Undergo fluorine F 18 sodium fluoride PET/CT
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan.
Description
Count of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease.
Time Frame
Up to 12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cy Stein, MD, PhD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
City of Hope South Pasadena
City
South Pasadena
State/Province
California
ZIP/Postal Code
91030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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