E. David Crawford, MD: Safety and Tolerability Issues

CASE 1: Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Bernie H. is a 75-year-old retired restaurant manager from Queens, New York, who now lives part time in Boca Raton, Florida. He and his wife enjoy boating and fishing.

His prior medical history is notable for mild COPD, which is well controlled with salbutamol, and for arthritis, with total knee replacement in 2007

In 2004, he presented to his PCP with symptoms of nocturia × 3. A suspicious digital rectal examination and elevated PSA of 9 mg/mL was noted

12 core biopsies revealed prostate adenocarcinoma of Gleason grade 7 (4 + 3) in 6 of 12 cores on the right side; he was treated with brachytherapy and a short course of 4 months of ADT. Within 6 months, his PSA had declined to undetectable levels (<.02 ng/mL). No further PSA testing was performed until 2011

In December 2011, the patient&rsquo;s PSA was noted to be 12 ng/mL.

Patient was asymptomatic at the time; however, a pelvic CT scan showed an enlarged right iliac lymph node measuring 2.3 cm &times; 2.2 cm; biopsy of the lesion was consistent with prostate adenocarcinoma

Bone scan at the time was negative

The patient was started on ADT with 3 months of depot leuprolide and bicalutamide, and his PSA reached a nadir of <.02 ng/mL; testosterone level was <10 ng/mL

The patient was asymptomatic, and PSA was monitored every 3 months. His PSA slowly rose from the nadir over the next 4 years in spite of ADT

His liver function tests were unremarkable

By March of 2015, the patient had experienced 2 consecutive rises in PSA, first to 16 ng/mL, and then to 27 ng/mL; his testosterone level was <20 ng/dL.

CT scan again detected enlargement of the prior iliac lymph node to 2.5 cm &times; 2.4 cm, and Bernie&rsquo;s physician confirmed a diagnosis of mCRPC in 2 additional lymph nodes

The patient remains asymptomatic, and his oncologist has ascertained progression of his disease

• A bone scan was not performed, because the patient wanted to return home as soon as possible
• Bernie and his wife are driving back to New York in their RV in late April. He wants to keep his cancer in check, but is concerned about side effects disrupting their trip