Summary

Prostate cancer (PC) is a type of cancer that affects the prostate gland of the male reproductive system, and is the most common non-cutaneous malignant cancer in men. Internationally, it is the sixth-largest cancer-related cause of death in men. Those aged over 50 are at the greatest risk of developing PC, with advanced age being the primary risk factor for the disease.

Most cases of PC (95%) are classed as adenocarcinomas, a type of cancer that arises in the cells of glands. Around 4% of cases display transitional cell morphology, and originate from the urothelial lining of the prostatic urethra. In rare cases prostate cancer may present with neuroendocrine morphology, and can arise from neuroendocrine stem cells present in the prostate. PC begins with the conversion of normal semen-secreting prostate gland cells into cancerous cells. In 75% of cases these start developing in the peripheral zone of the prostate – the site closest to the rectum.

PC is often asymptomatic, which can lead to a lack of diagnosis in the early stages of the disease, rendering treatment less effective once a diagnosis is made. If symptoms are present or if a diagnosis has been made during a physician’s examination, depending on the stage of the disease, the cancer may be treated through surgical removal of cancerous cells, radiation therapy, or a combination of both.

The PC market consists of therapies for both hormone-sensitive and castration-resistant forms of the disease. The options available for the two forms are notably different, with hormonal therapies used in the hormone-sensitive stage, and chemotherapy or targeted therapies used in the castration-resistant stage. Castration-resistant PC relates to both symptomatic and asymptomatic forms of the disease that no longer respond to hormonal therapy.

Hormonal therapies are widely used across multiple stages of hormone-sensitive disease, and the goal is to halt PC growth stimulated by testosterone. There are two methods used to treat PC through targeting hormones. The first is androgen deprivation therapy (ADT) using gonadotropin releasing hormone (GnRH) agonists and antagonists, and the second is androgen receptor (AR) blockage, using compounds termed anti-androgens.

The differences between many of these products are relatively nuanced, and must be understood fully by companies seeking to position a novel drug in this market. This tabular heatmap framework, designed to provide an easily digestible summary of these clinical characteristics, provides detailed information on all late-stage clinical trial results for products in the PC market and late-stage pipeline. These are split along lines of therapy, and are therefore reflective of the treatment algorithm.

All safety and efficacy endpoints reported in these trials are displayed, for both the drug and comparison groups. In addition, key study characteristics such as the size, composition and patient segment of the study population are provided. These results are presented in a visually accessible, color-coded manner in order to maximize ease of use.

The accompanying text provides a detailed analysis of the clinical benchmarks set by the current market landscape, and the anticipated changes to these benchmarks, and to the treatment algorithm, as a result of the late-stage pipeline.

Scope

- What are the clinical characteristics of currently approved therapies for PC, in terms of specific safety and efficacy parameters?
- What are the key unmet needs in this indication, and which clinical safety and efficacy parameters are most closely linked to them?
- Which novel classes of therapy are expected to emerge in the treatment of PC?
- Which targets do these therapies act upon?
- Which sub-types of patients could potentially benefit from these new products?

Reasons to buy

- Understand the current clinical landscape by considering the treatment options available for each patient segment.
- Visually compare the currently approved treatments available at each line of therapy, based on the most important efficacy and safety parameters tested in clinical trials.
- Assess the current late-stage pipeline, in terms of the likely positioning of each product and the implications for the clinical landscape at each line of therapy.
- Understand the relative strengths and weaknesses of the studies used to gather these data.
- Build up a nuanced understanding of the clinical benchmarks set by these products, and consider how the current late-stage pipeline will affect these benchmarks.
- Assess your own pipeline programs in light of these benchmarks in order to optimally position them and maximize uptake by clinicians.