Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT03619655
- Brief Summary
The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT.
- Detailed Description
The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT. The study will consist of 3 cohorts, and a subset of the patients in cohort C will participate in a test-retest study, where the baseline SPECT/CT will be repeated.
SPECT CT will be performed in all cohorts.
Cohort A will evaluate SPECT CT by comparison to a Positron Emission Tomography (PET) scan using NaF.
Cohort B will evaluate SPECT CT by comparison to 18F-DCFPyL PET/CT.
Cohort C will evaluate SPECT CT by comparison to Whole Body Magnetic Resonance Imaging (WB-MRI).
Eligible subjects will be enrolled in a non-randomized manner per the treating physician discretion.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 3
Males ≥18 years of age. Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
Histologically confirmed adenocarcinoma of the prostate. Metastatic castration-resistant prostate cancer (mCRPC) with Bone metastases as manifested by one or more lesions on bone scan.
Documented castrate level of serum testosterone (≤50 ng/dl).
Documented progressive mCRPC based on at least one of the following criteria:
- PSA progression defined as 25% increase over baseline value or nadir.
- Radiographic progression for soft tissue lesions as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and/ or radiographic progression for bone lesions as determined by radionuclide bone scan using the consensus guidelines of the PCWG3 criteria.
Planning to receive first line novel hormonal therapy with Abiraterone or Enzalutamide for the first time for mCRPC within 4 weeks of documented progression. Baseline scans will be obtained prior to starting new therapy.
Subjects who are unable to give valid informed consent Subjects who are unwilling or unable to undergo an SPECT, PET or MR exam, including subjects with contra-indications to MR exams.
Subjects with prior Enzalutamide and Abiraterone for mCRPC Subjects with prior taxane chemotherapy for mCRPC Subjects administered any radioisotope within five physical half-lives or any IV X-ray contrast medium within 24 hours or any high density oral contrast medium (oral water contrast is acceptable) within 5 days prior to study drug injection.
Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
Patients with a history reaction to gadolinium contrast agent. For cohort C, patients with renal failure (eGFR < 60ml/min/1.73m2) or patients on dialysis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description "Cohort B" - SPECT CT and 18F-DCFPyL PET/CT 18F-DCFPyL PET/CT Intervention 1: SPECT CT Intervention 2: 18F-DCFPyL PET/CT "Cohort B" - SPECT CT and 18F-DCFPyL PET/CT SPECT CT Intervention 1: SPECT CT Intervention 2: 18F-DCFPyL PET/CT "Cohort A" - SPECT CT and NaF PET SPECT CT Intervention 1: SPECT CT Intervention 2: NaF PET "Cohort A" - SPECT CT and NaF PET 18F-NaF PET/CT Intervention 1: SPECT CT Intervention 2: NaF PET "Cohort C" - SPECT CT and WB-MRI SPECT CT Intervention 1: SPECT CT Intervention 2: WB-MRI "Cohort C" - SPECT CT and WB-MRI WB-MRI Intervention 1: SPECT CT Intervention 2: WB-MRI
- Primary Outcome Measures
Name Time Method Accuracy for Prediction of Progression Free Survival as determined by Quantitative bone SPECT indices (QBSIs) Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years QBSI will be measured on SPECT scans at pre-defined intervals. A lower QBSI would mean likelier progression free survival.
- Secondary Outcome Measures
Name Time Method Reproducibility of the QBSIs using test-retest studies in 12 patients 5 years Reproducibility measured by difference in QBSI between test-retest in 12 patients, as defined by the protocol. A smaller difference in QBSI reflects greater reproducibility.
Ability of QBSPECT to detect recurrence of metastatic disease as determined by QBSI in 60 patients. Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years QBSI will be measured on QBSPECT images obtained at the same time as standard-of-care bone scans. A higher QBSI would predict earlier recurrence of metastasis.
Accuracy of NaF PET/CT as determined by difference in QBSI from SPECT versus QBSI from NaF PET/CT in 20 patients Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years Difference in QBSI from SPECT versus NaF PET/CT. A smaller difference in the measured QBSI would reflect a higher accuracy of Na18F PET/CT. These images will be acquired within 32 hours of the bone scintigraphy scans at the pre-defined time points, per protocol.
Accuracy of PSMA PET/CT as determined by difference in QBSI from SPECT versus QBSI from PSMA PET/CT in 20 patients Baseline, 6 months post-treatment, assessed up to 5 years Difference in QBSI from SPECT versus PSMA PET/CT. A smaller difference in the measured QBSI would reflect a higher accuracy of PSMA PET/CT. These images will be acquired within 32 hours of the bone scintigraphy scans at the pre-defined time points, per protocol.
Correlation of QBSI from SPECT/CT to restricted diffusion obtained from whole body MRI 5 years Ratio of QBSI obtained from SPECT imaging to quantitative biomarkers of restricted diffusion (diffusion-weighted imaging) obtained from a WB-MRI protocol.
Trial Locations
- Locations (2)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States