Prospective CiRculating prOstate Cancer Predictors in HighEr Risk mCRPC studY

Inclusion Criteria

• •1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Pure small cell or neuroendocrine tumors of the prostate are not permitted.
• •2. Clinical or radiographic evidence of metastatic disease.
• •3. Planned therapy with either enzalutamide and/or abiraterone acetate within the coming 6 weeks
• •4. Castrate levels of testosterone (\<50 ng/dl) at most recent assessment and/or documented ongoing Androgen Deprivation Therapy for at lease three months.
• •5. Evidence of disease progression on or following most recent therapy as evidenced by at least one of the following:
• •* Radiographic evidence of disease progression as defined by one or more new bone scan lesions that is not consistent with flare/healing, or growth of soft tissue/visceral metastases to greater than one centimeter (cm) in longest diameter (2 cm shortest diameter for lymph nodes).
• •* Clinical progression as defined by the treating physician (such as pain progression)
• •* Consecutive PSA rises meeting PSA progression criteria as determined by PCWG2 criteria (increase that is \>25% and \>2 ng/mL above the nadir, and which is confirmed by a second value 3 or more weeks later)
• •6. At least two of the following high risk features during screening for rapid disease progression:
• •1. Anemia with a hemoglobin \<12.0 g/dl
• •2. Elevated alkaline phosphatase above the institution upper limit of normal
• •3. High lactate dehydrogenase (LDH) above the upper limit of normal
• •4. Prior therapy with enzalutamide, abiraterone acetate, or orteronel. Patients are not permitted if they are continuing on the same therapy or restarting a therapy that they have been exposed to in the past.
• •5. Presence of visceral metastasis on imaging
• •6. Presence of clinically significant pain requiring opioid analgesia
• •7. Patients with a Cellsearch CTC \> 5 cells per 7.5 mL whole blood (if available as standard of care) are eligible without additional high risk features
• •8. PSA doubling time under 3 months on most recent therapy
• •9. Radiographic progression at entry based on new lesion(s) in bone, soft tissue, or visceral metastases
• •7. Age \> 18 years.
• •8. Ability to understand and the willingness to sign a written informed consent document.