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

Recurrent Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967862
• Other study ID #: 13365
• Secondary ID: NCI-2013-0192413
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: September 17, 2018

Study information

• Verified date: September 2018
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 17, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Recurrent Prostate Cancer

Intervention

Procedure:
• computed tomography
Undergo CT
• bone scan
Undergo bone scan
• 3-Tesla magnetic resonance imaging
Undergo axial MRI
• diffusion-weighted magnetic resonance imaging
Undergo WB MRI

Radiation:
• fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET/CT

Procedure:
• computed tomography
Undergo fluorine F 18 sodium fluoride PET/CT
• positron emission tomography
Undergo fluorine F 18 sodium fluoride PET/CT

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California
United States	City of Hope South Pasadena	South Pasadena	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months