Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy
The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT.
• 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.