Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer

This is a single-arm observational longitudinal study in of patients with metastatic
castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and
other symptoms. The study aims to address several key methodological questions that will
inform the design of future clinical trials with symptom endpoints in this population,
including: the definition of "clinically meaningful" pain; criteria for concluding a
clinically meaningful pain reduction; criteria for concluding clinically meaningful pain
progression; reliable methods quantifying analgesic use (given that "equianalgesic tables"
and "point scoring systems" are generally considered unreliable by pain researchers and
regulatory agencies , , ); ideal recall periods for pain questions; tradeoffs of different
frequencies of symptom reporting; symptom trajectories over time; and associations of pain
scores with other metrics used in prostate cancer research (imaging, PSA values, circulating
tumor cells, etc).

Inclusion Criteria:

- The subject must be ≥ 18 years old on the day of consent.

- The subject is able to understand written and spoken English

- The patient must have histologically or cytologically confirmed prostate
adenocarcinoma.

- The subject must have castration-resistant prostate cancer (CRPC)

- The subject must have metastatic disease involving bone, seen on radiographic imaging
(bone scan, CT scan, PET scan, or MRI).

- The subject must be in a castrate state (e.g., currently receiving androgen
deprivation therapy or have had an orchiectomy).

- The subject must be starting any line treatment post-androgen deprivation/antiandrogen
therapy, such as the following: chemotherapy (e.g., docetaxel, paclitaxel,
carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100;
ketoconazole; sipuleucel-T; Radium 223.

- The subject owns or has regular access to a telephone (cellular or land line).

- The subject is willing and able to self-report pain and analgesic use via an automated
telephone system.

- The subject is willing and able to provide informed consent.

Exclusion Criteria:

- The subject has small cell or predominantly neuroendocrine differentiated prostate
tumor.