Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy
Status and phase
Conditions
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Study type
Funder types
Identifiers
Details and patient eligibility
About
The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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.
Exclusion criteria
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
3 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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