Fluorine F 18 DCFPyL PET/CT and PET/MRI in Imaging Patients with Prostate Cancer
This early phase I studies how well fluorine F 18 DCFPyL positron emission tomography (PET)/computed tomography (CT) and PET/magnetic resonance imaging (MRI) work in imaging patients with prostate cancer. Diagnostic procedures, such as fluorine F 18 DCFPyL PET/CT and PET/MRI, may more accurately diagnose prostate cancer, identify the stage of the cancer, and see if the cancer has spread to other parts of their body after treatment with hormonal therapy.
Inclusion Criteria
- SUB-STUDY I: Newly diagnosed prostate cancer pathologically proven by prostate biopsy
- SUB-STUDY I: Prostate biopsy histology grade >= Gleason 6, positive biopsy > 2 cores
- SUB-STUDY I: Patients considered as candidates for and medically fit to undergo prostatectomy
- SUB-STUDY I: At least 7 days after most recent prostate biopsy
- SUB-STUDY II: Prostate cancer pathologically proven by prostate biopsy
- SUB-STUDY II: Planned salvage external beam radiation therapy
- SUB-STUDY II: Biochemical recurrence with PSA > 0.2 ng/mL on two successive tests
- SUB-STUDY III: Prostate cancer pathologically proven by prostate biopsy
- SUB-STUDY III: Two consecutive rising PSA values
- SUB-STUDY III: Castrate-levels of testosterone (total testosterone < 50 ng/dL)
- SUB-STUDY III: Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI, ultrasound or other PET modalities
Exclusion Criteria
- SUB-STUDY I: Prior pelvic external beam radiation therapy or brachytherapy
- SUB-STUDY I: Chemotherapy for prostate cancer
- SUB-STUDY I: Androgen deprivation therapy for prostate cancer
- SUB-STUDY I: Unable to lie flat during or tolerate PET/CT
- SUB-STUDY I: Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
- SUB-STUDY I: No prostatectomy scheduled more than 12 hours post imaging
- SUB-STUDY I: Serum creatinine > 2 time the upper limit of normal
- SUB-STUDY I: Total bilirubin > 3 times the upper limit of normal
- SUB-STUDY I: Liver transaminases > 5 times the upper limit of normal
- SUB-STUDY II: Prior pelvic external beam radiation therapy or brachytherapy
- SUB-STUDY II: Chemotherapy for prostate cancer
- SUB-STUDY II: Androgen deprivation therapy for prostate cancer
- SUB-STUDY II: Unable to lie flat during or tolerate PET/CT
- SUB-STUDY II: Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
- SUB-STUDY II: Serum creatinine > 2 time the upper limit of normal
- SUB-STUDY II: Total bilirubin > 3 times the upper limit of normal
- SUB-STUDY II: Liver transaminases > 5 times the upper limit of normal
- SUB-STUDY III: Radiation therapy or start of standard of care systemic therapy (chemotherapy, androgen deprivation therapy) within 14 days prior to study PET
- SUB-STUDY III: Investigational therapy for prostate cancer less than 28 days prior to study PET imaging
- SUB-STUDY III: Unable to lie flat during or tolerate PET/CT
- SUB-STUDY III: Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
- SUB-STUDY III: Serum creatinine > 3 times the upper limit of normal
- SUB-STUDY III: Total bilirubin > 3 times the upper limit of normal
- SUB-STUDY III: Liver transaminases > 5 times the upper limit of normal
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03232164.
PRIMARY OBJECTIVES:
I. To evaluate the performance of fluorine F 18 DCFPyL (18F-DCFPyL) prostate-specific membrane antigen (PSMA)-based PET and multi-parametric MRI (MP-MRI) with diffusion weighted imaging (DWI) and gadolinium dynamic contrast-enhanced (DCE) using a dedicated PET/MRI scanner to detect clinically significant larger volume high-grade primary prostate cancer based on prostatectomy step-section pathology correlation. (Sub-study #1)
II. To evaluate the performance of 18F-DCFPyL PSMA-based PET for localization of the site of recurrent prostate cancer in men with biochemical recurrence after definitive prostatectomy with planned salvage external-beam radiation therapy (EBRT). (Sub-study #2)
III. To compare the detectability of metastatic prostate cancer using 18F-DCFPyL PET obtained from PET/CT and PET/MRI compared to conventional imaging modalities (CIM) (bone scan and CT) in men with androgen-resistant prostate cancer. (Sub-study #3)
SECONDARY OBJECTIVES:
I. Evaluate the performance of 18F-DCFPyL PET and MRI whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy). (Sub-study #1)
II. Correlate 18F-DCFPyL PET standardized-uptake values (SUV) and MRI parameters with PSMA expression by prostatectomy pathology IHC. (Sub-study #1)
III. Evaluate the specificity of 18F-DCFPyL PET for differentiating primary prostate cancer versus non-malignant prostate lesions (benign prostatic hyperplasia [BPH], prostatitis). (Sub-study #1)
IV. Comparison of whole body low-dose CT and whole body MRI derived PET SUV-quantitation. (Sub-study #1)
V. Comparison of whole body 18F-DCFPyL PET with pelvic MR-MRI and whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy). (Sub-study #2)
VI. Evaluate the performance of dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI for differentiation of urine versus recurrent malignancy in the prostatectomy bed. (Sub-study #2)
VII. Evaluate the contribution of whole body MRI DWI obtained from PET/MRI to improve the diagnostic performance of 18F-DCFPyL PET/CT and PET/MRI for metastatic prostate cancer lesion detection. (Sub-study #3)
VIII. Assess the quantitative accuracy of PET-derived standardized uptake value (SUV)-based parameters in 18F-DCFPyL PET obtained from PET/MRI versus PET/CT. (Sub-study #3)
IX. Assess the quantitative reproducibility of 18F-DCFPyL PET/CT derived-SUV values in normal organ and metastatic tumor lesions. (Sub-study #3)
OUTLINE: Patients are assigned to 1 of 3 sub-studies.
SUB-STUDY I: Patients with newly diagnosed prostate cancer receive 18F-DCFPyL intravenously (IV) and then undergo PET/CT scan over 20-30 minutes followed immediately by a PET/MRI scan over 45 minutes. Patients also receive gadolinium IV and undergo PET/MRI scan over 30 minutes.
SUB-STUDY II: Patients with biochemical recurrence receive 18F-DCFPyL and undergo PET/CT followed by PET/MRI, and receive gadolinium followed by PET/MRI as in Sub-study I.
SUB-STUDY III: Patients with androgen-resistant metastatic prostate cancer receive 18F-DCFPyL IV and then undergo PET/CT scan over 20-30 minutes followed immediately by a PET/MRI scan over 60 minutes. Patients may also receive 18F-DCFPyL IV and then undergo PET/CT scan over 20-30 minutes 3-7 days later.
After completion of study treatment, patients are followed up at 1-3 days.
Trial PhasePhase O
Trial Typediagnostic
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorSteve Yoon-Ho Cho
- Primary IDUW16062
- Secondary IDsNCI-2017-01643, 2016-0883
- ClinicalTrials.gov IDNCT03232164