PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer
Status
RECRUITING
Phase
EARLY_PHASE1
Age
≥ 18 Years
Enrollments
136Conditions
Prostate Cancer, Prostate NeoplasmDrugs
18F-DCFPyL PETSummary
The overall goal of this research is to validate and develop a non-invasive imaging biomarker of prostate cancer detection, progression, and recurrence. Development of such a biomarker may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing for selection of an appropriate risk adaptive therapy.
Detailed Description
The investigators propose to evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL, for detection of primary and metastatic prostate cancer. 18F-DCFPyL PET demonstrates very high tumor-to-background and tumor specific uptake which may allow for a more sensitive and accurate method for detection of early tumor recurrence and metastatic disease as compared to current PET radiotracers and current standard-of-care imaging including 99mTc-methylene diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI).
Primary Objectives: The investigators propose to evaluate this PET agent for four different prostate cancer clinical scenarios.
1. detection of clinically significant high-grade prostate cancer and initial staging
2. detection of sites of recurrence in the setting of biochemical recurrence after definitive prostatectomy
3. detection of advanced androgen-resistant metastatic prostate cancer, and
4. detection of clinically significant prostate cancer in very low to intermediate risk primary prostate cancer
Secondary Objectives:
* 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).
* Correlate 18F-DCFPyL PET standardized-uptake values (SUV) and MRI parameters with PSMA expression by prostatectomy pathology IHC.
* Evaluate the specificity of 18F-DCFPyL PET for differentiating primary prostate cancer versus non-malignant prostate lesions (BPH, prostatitis).
* Comparison of whole body low-dose CT and whole body MRI derived PET SUV-quantitation.
* 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.
* 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.
* Assess the quantitative accuracy of PET-derived standardized uptake value (SUV)-based parameters in 18F-DCFPyL PET obtained from PET/MRI versus PET/CT.
* Assess the quantitative reproducibility of 18F-DCFPyL PET/CT derived-SUV values in normal organ and metastatic tumor lesions.
* Evaluate the ability of 18F-DCFPyL PET to improve detection of clinically significant primary prostate cancer in men with very low to intermediate risk prostate cancer under active surveillance or watchful waiting.
Update: As of July 2022 verification, the investigators are no longer enrolling into sub-studies 1 and 2.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Cancer Connect
- 800-622-8922
- [email protected]
Principal Investigator
- Steve Y Cho, MD
Eligibility Criteria
Inclusion Criteria:
* Prostate cancer pathologically proven by prostate biopsy (newly diagnosed for Sub-Study 1 and 4)
* Prostate biopsy histology grade ≥ Gleason 1, 6, 3+4, or 4+3; positive biopsy >2 cores
* Any PSA permitted
* Two consecutive rising PSA values (Sub-Study 3 only)
* Castrate-levels of testosterone - total testosterone < 50 ng/dL (Sub-Study 3 only)
* Patients considered as candidates for and medically fit to undergo prostatectomy
* At least 7 days after most recent prostate biopsy
* Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI, ultrasound or other PET modalities (Sub-Study 3 only)
* New diagnosis of prostate cancer undergoing additional biopsy evaluation (Sub--Study 4 only)
* Karnofsky performance status of at least 70 (Sub-Study 4 only)
* General health and anatomy suitable to undergo transrectal ultrasound-MRI fusion biopsy of the identified lesions and standard 12 core sextent biopsy (Sub-Study 4 only)
Exclusion Criteria:
* Prior pelvic external beam radiation therapy or brachytherapy
* Chemotherapy for prostate cancer
* Androgen deprivation therapy for prostate cancer
* Investigational therapy for prostate cancer (Sub-Study 3 Only)
* Unable to lie flat during or tolerate PET/CT
* 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.
* No prostatectomy scheduled more than 12 hours post imaging (Sub-Study 1 only)
* Serum creatinine > 2 time the upper limit of normal
* Total bilirubin > 3 times the upper limit of normal
* Liver Transaminases > 5 times the upper limit of normal
Study Plan
18F-DCFPyL PET
EXPERIMENTAL
Four separate substudies evaluating 18F-DCFPyL PET imaging of prostate cancer in four prostate cancer clinical scenarios under the following subheadings: (1) primary prostate cancer, (2) biochemical recurrence post-prostatectomy prior to radiation therapy, (3) androgen-resistant metastatic disease and (4) detection of clinically significant prostate cancer in low to intermediate risk primary prostate cancer
DRUG:
18F-DCFPyL PETDescription:
18F-DCFPyL PET demonstrates very high tumor-to-background and tumor specific uptake which may allow for a more sensitive and accurate method for detection of early tumor recurrence and metastatic disease as compared to current PET radiotracers and current standard-of-care imaging including 99mTc-methylene diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI).
Outcome Measures
Primary Outcome Measures
18F-DCFPyL PSMA-based PET and multi-parametric MRI with DWI for Sub-Study 1: Primary Prostate Cancer
Evaluate 18F-DCFPyL PSMA-based PET for localization for Sub-Study 2: Biochemical Recurrence
Compare detectability of 18F-DCFPyL for Sub-Study 3: Metastatic Androgen-Resistant Prostate Cancer
Sub-Study 4: Rate of positive cancer detection using PET/MRI directed MRI/transrectal ultrasound (TRUS) fusion biopsy with and without additional PSMA PET information
Secondary Outcome Measures
Sub-study 1: Detection of local-nodal and distant metastatic disease (PET
Sub-Study 1: Correlation of 18F-DCFPyL PET and MRI
Sub-Study 1: Specificity of 18F-DCFPyL
Sub-Study 1: Low-dose CT versus MRI derived PET SUV
Sub-Study 2: Detection of local-nodal and distant metastatic disease (pelvic)
Sub-Study 2: Dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI
Sub-Study 3: Contribution of whole body MRI DWI
Sub-Study 3: Quantitative accuracy
Sub-Study 3: Quantitative reproducibility
Sub-study 4: Positive Detection Rate of Prostate Cancer via biopsy on PSMA PET versus mpMRI alone in very low to intermediate risk groups active surveillance and watchful waiting patients
Sub-study 4: Detection rate of clinically significant prostate cancer in men with directed MRI/US biopsy
Sub-study 4: Detection Rate of Prostate Cancer vs False Positive Findings via Biopsy
Sub-study 4: Number of Participants who change treatment and surgical management plans after inclusion of PSMA-based PET directed biopsy
Sub-study 4: Correlation of PET and MRI parameters for PET and/or MRI positive lesions to biopsy histopathology, cancer grade group, PSA and other clinical parameters
Sub-study 4: Change in Gleason Score
Timeline
Last Updated
August 30, 2024Start Date
July 27, 2017Today
January 23, 2025Completion Date ( Estimated )
December 31, 2024
Sponsors of this trial
Lead Sponsor
University of Wisconsin, Madison
RECRUITING 
21 - 64 Years