NCT01967862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

September 17, 2020

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2018

Enrollment Period

4.8 years

First QC Date

October 18, 2013

Results QC Date

August 26, 2020

Last Update Submit

August 26, 2020

Conditions

Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

EXPERIMENTAL

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 tomographyProcedure: bone scanProcedure: 3-Tesla magnetic resonance imagingProcedure: diffusion-weighted magnetic resonance imagingRadiation: fluorine F 18 sodium fluorideProcedure: positron emission tomographyOther: laboratory biomarker analysis

Interventions

computed tomographyPROCEDURE

Undergo CT

Also known as: tomography, computed
Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT)
bone scanPROCEDURE

Undergo bone scan

Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT)
3-Tesla magnetic resonance imagingPROCEDURE

Undergo axial MRI

Also known as: 3-Tesla MRI, 3T MRI
Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT)
diffusion-weighted magnetic resonance imagingPROCEDURE

Undergo WB MRI

Also known as: diffusion-weighted MRI
Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT)
fluorine F 18 sodium fluorideRADIATION

Undergo fluorine F 18 sodium fluoride PET/CT

Also known as: 18 F-NaF, F-18 NaF
Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT)
positron emission tomographyPROCEDURE

Undergo fluorine F 18 sodium fluoride PET/CT

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT)
laboratory biomarker analysisOTHER

Correlative studies

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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope South Pasadena

South Pasadena, California, 91030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Paul Frankel, Ph.D.
Organization
City of Hope
pfrankel@coh.org
626-218-5265

Study Officials

  • Cy Stein, MD, PhD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2013

First Posted

October 23, 2013

Study Start

December 1, 2013

Primary Completion

September 17, 2018

Study Completion

September 17, 2018

Last Updated

September 17, 2020

Results First Posted

September 17, 2020

Record last verified: 2018-09

Locations

US(2)