“Each year more patients present with prostate cancer at increasingly younger ages and with earlier-stage disease, resulting in the potential for longer survival time, longer-term hormonal therapy, and a heightened risk of developing biochemical recurrence after treatment. It seems clear that clinicians need to broaden the definition of “advanced” prostate cancer to include recent knowledge that will influence the form and timing of treatment as well as the monitoring of disease progression.” [Rev Urol. 2004;6 (suppl 8):S10-S17]

This comment from 2004 seems more prescient today than ever. It is now estimated that one in six men will get prostate cancer, the majority of them after age 65. Prostate cancer is the second-leading cause of cancer death in men, after lung cancer.

The prostate cancer market is large and utilizes all therapy modalities, including surgery, radiation, brachytherapy, hormone therapy, immunotherapy, chemotherapy, and supportive-care agents, such as bone-resorption and remodeling products. Understanding this market requires knowledge of the lengthy disease process, stratification of patients who are at high risk of recurrence, and careful analysis of the two specialty groups who most often treat this disease: urologists and oncologists.

The selection of initial therapy in men with prostate cancer incorporates many pieces of information to stratify the patient’s risk of disease progression as low, intermediate, or high.

Eighty percent of men who present with clinically localized disease and receive definitive therapy will have a biochemical recurrence or systemic failure (Klein et al, JCO 2005). While the definition of high-risk disease can be interpreted in different ways, it is widely agreed that prostate-specific antigen (PSA) value and Gleason score are foundations of accurate risk stratification. Brand teams and marketers need to have as much information as possible to appropriately reach the audience that is primarily treating and monitoring high-risk prostate cancer patients.

Urologists remain the front line in treatment of prostate cancer, regardless of disease stratification. They routinely perform disease surveillance via PSA testing at intervals based upon the disease stratification at diagnosis. Urologists perform prostatectomies, orchiectomies, refer patients to radiation oncologists, and typically prescribe initial androgen-deprivation therapy.

Biochemical recurrence – defined as a rising PSA level after initial therapy – is the most common presentation of advanced prostate cancer. This early warning of advanced disease presents a dilemma for clinicians. Which therapy to start and for what interval can be confounding when taking into account patient age, comorbid conditions, costs, and length of additional therapy. Brand teams need to address and account for these subtleties within the high-risk prostate cancer market.

The pattern and timing of referral from urologist to oncologist is poorly understood but remains critical in determining patient eligibility for subsequent therapies, including the bone-resorption agents (bisphosphonates and RANK ligand inhibitors), immunotherapy, and chemotherapy.

Pathologic fractures related to bone metastasis are a hallmark of disease progression in prostate cancer patients. These fractures seriously impact patients’ quality of life and overall survival. The bisphosphonate market, which includes osteoporosis as well as metastatic bone disease, is valued at $2 billion a year and is dominated by Zometa (zoledronic acid). The recent launch of the RANK ligand inhibitor denosumab, with its superior data, will impact this market; however, it will face cost/benefit obstacles.

The recent approvals of abiraterone, sipuleucel-T, and cabazitaxel are bright spots for treatment of hormone-refractory prostate cancer. These promising new therapies are currently carrying course-of- treatment price tags ranging from $20,000 to $90,000. All have shown survival data in this extremely-difficult-to-treat patient population. Medicare will foot the bulk of the bill for these therapies; abiraterone is an oral agent and will fall under Medicare Part D.

Prostate cancer therapy is undergoing a renaissance. New therapies, better screening, and patient risk stratification are helping men live longer with a better quality of life. Brand teams need to be aware of which specialty groups are managing these patients, and at what point specific local and targeted therapies are clinically appropriate for use.

 

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