N/A
N=54
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
Bottom Line
View on ClinicalTrials.gov: NCT01967862 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan. — 0; 0; 12; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- computed tomography (Procedure); bone scan (Procedure); 3-Tesla magnetic resonance imaging (Procedure); diffusion-weighted magnetic resonance imaging (Procedure); fluorine F 18 sodium fluoride (Radiation); positron emission tomography (Procedure); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- City of Hope Medical Center
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan. |
0; 0; 12; 17 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01967862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.