ASCO Provisional Clinical Opinion: Second-Line Hormonal Therapy for Chemotherapy-Naive Castration-Resistant Prostate Cancer

As reported by Katherine S. Virgo, PhD, MBA, of Emory University, and colleagues in the Journal of Clinical Oncology, ASCO has issued a provisional clinical opinion on second-line hormonal therapy for chemotherapy-naive castration-resistant prostate cancer. The provisional clinical opinion applies to men who range from asymptomatic with only biochemical evidence of disease to those who documented metastases but few symptoms.

The provisional clinical opinion was based on an expert panel and consensus panel review of six phase III randomized controlled trials and expert consensus opinion. The expert panel was co-chaired by Dr. Virgo and Eric A. Singer, MD, of Rutgers Cancer Institute of New Jersey.

The key elements of the provisional clinical opinion are summarized/reproduced here. Except where noted, the opinions are based on formal consensus of the expert and consensus panels.

Key Points

  • Men who develop castration-resistant prostate cancer despite castrate levels of testosterone should be maintained in a castrate state indefinitely.
  • No data support the use of second-line hormonal therapies for chemotherapy-naive men with M0 castration-resistant prostate cancer who are at a low risk of developing metastases. (Low risk is defined as low prostate-specific antigen [PSA] and slow PSA doubling time.)
  • For chemotherapy-naive patients at high risk of developing metastases (rapid PSA doubling time or velocity), second-line hormonal therapies that lower PSA values or slow the rate of rise may be offered, preferably in a clinical trial setting where available, after a discussion with the patient about limited scientific evidence, potential harms, benefits, costs, and patient preferences.
  • Abiraterone acetate [Zytiga] plus prednisone or enzalutamide [Xtandi] should be offered for second-line hormonal treatment after first-line hormonal treatment failure for chemotherapy-naive men who develop castration-resistant prostate cancer and have radiographic evidence of metastases (M1a/M1s castration-resistant prostate cancer), because these agents have been shown to significantly increase radiographic progression–free and overall survival. [Provisional clinical opinion type: evidence based (three randomized controlled trials); strength of provisional clinical opinion: strong]
  • A PSA evaluation every 4 to 6 months should be performed for men who develop castration-resistant prostate cancer and have no radiographic evidence of metastases (M0 castration-resistant prostate cancer) and a slow PSA doubling time or velocity. If PSA levels are rising, checking serum testosterone levels should be considered.
  • A PSA evaluation every 3 months is recommended for men who develop castration-resistant prostate cancer with a rapid PSA doubling time, velocity, or radiographic evidence of metastases (M1 castration-resistant prostate cancer).
  • When imaging is performed for men with castration-resistant prostate cancer, a bone scan and either computed tomography or magnetic resonance imaging of the abdomen and pelvis should be offered. Of note is that sodium fluoride positron-emission tomography (18-F–labeled positron-emission tomography) imaging is only approved in the United States for the diagnosis of recurrent prostate cancer among men with an elevated PSA level after treatment. The use of this technique is otherwise limited to patients who participate in clinical trials and prospective registries. Whole-body magnetic resonance imaging to detect oligometastatic disease and radiotracers and imaging agents such as c-11 choline, prostate-specific membrane antigen, and 18-F–flucicovine currently are considered investigational for chemotherapy-naive patients with castration-resistant prostate cancer.
  • Radiographic imaging is not indicated for men with castration-resistant prostate cancer and a rising PSA unless treatment selection would be altered on the basis of radiographic findings or if symptoms potentially attributable to prostate cancer develop or worsen (eg, bone pain). Routine surveillance radiographic restaging also is not indicated, with the exception of patients for whom PSA is not a reliable marker of disease.
  • Palliative care should be offered to all chemotherapy-naive men with M1 castration-resistant prostate cancer, particularly those who exhibit symptoms or decreased quality of life.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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