Plain language summary of the results from the TALAPRO-2 study: Talazoparib plus enzalutamide versus placebo plus enzalutamide for patients with advanced prostate cancer.

WHAT IS THIS SUMMARY ABOUT?: This summary describes the results from the TALAPRO-2 research study (also known as a clinical trial). The TALAPRO-2 study tested the combination of two medicines called talazoparib plus enzalutamide. This combination of medicines was used as the first treatment for adult patients with metastatic castration-resistant prostate cancer. The combination of talazoparib plus enzalutamide was compared with a placebo plus enzalutamide. WHAT IS METASTATIC CASTRATION-RESISTANT PROSTATE CANCER?: Metastatic castration-resistant prostate cancer is a type of cancer that starts in the prostate and has spread to other parts of the body. Castration-resistant means that the cancer continues to grow even when testosterone levels in the blood are reduced to very low levels. Taking medicines to lower testosterone levels in the blood is a standard treatment for men with advanced prostate cancer. WHAT ARE THE AIMS OF THE TALAPRO-2 TRIAL?: TALAPRO-2 looked at if combining talazoparib plus enzalutamide would increase the length of time patients lived before their cancer got worse or they died compared with a placebo plus enzalutamide. Researchers looked at how treatment affected the size and number of tumors and the length of time before patients needed to change to a new cancer medicine. Researchers also looked at any side effects patients had during the study. WHAT ARE THE KEY TAKEAWAYS?: A total of 805 patients with metastatic castration-resistant prostate cancer took part in the study. Compared with patients who took a placebo plus enzalutamide, the group of patients who took talazoparib plus enzalutamide had a 37% reduced risk of their cancer getting worse or dying. Some patients had tumors that at the start of the study could be measured with scans. Sixty-two percent of patients who took talazoparib plus enzalutamide had their tumors decrease or shrink to the point that they could no longer be seen on scans versus 44% of patients who took a placebo plus enzalutamide. Patients who took talazoparib plus enzalutamide were more likely to have a longer time before they needed to change to a new cancer medicine. The most common side effects of talazoparib plus enzalutamide were low levels of red blood cells (66% of patients) and neutrophils (36% of patients), and excessive tiredness or exhaustion (34% of patients).Clinical Trial Registration: NCT03395197 (TALAPRO-2) (ClinicalTrials.gov).

Enzalutamide in metastatic hormone-sensitive prostate cancer: A plain language summary of the ARCHES and ENZAMET follow-up studies.

WHAT IS THIS SUMMARY ABOUT?: This summary includes information from the ARCHES and ENZAMET follow-up studies. Both studies looked at enzalutamide treatment for people with metastatic hormone-sensitive prostate cancer (known as mHSPC). In ARCHES, researchers compared the medications enzalutamide + androgen deprivation therapy (known as ADT) with placebo + ADT. In ENZAMET, researchers compared enzalutamide + ADT with standard treatment + ADT. Some people in ENZAMET also took enzalutamide with docetaxel (a chemotherapy treatment). In both studies, researchers wanted to find out if enzalutamide helps people with mHSPC live longer. WHAT ARE THE KEY TAKEAWAYS?: In both studies, researchers found that people with mHSPC who took enzalutamide lived longer than people who did not. People who took enzalutamide also lived longer without their cancer getting worse. The results were mostly similar in groups of people dependingon when and where their cancer was found. Researchers did not find any new safety concerns. WHAT WERE THE MAIN CONCLUSIONS?: People with mHSPC may benefit from long-term treatment with enzalutamide + ADT. They may also benefit from taking enzalutamide with other treatments, like docetaxel. It may be better for people with mHSPC to have enzalutamide treatment before their cancer gets worse, rather than waiting. These people and their doctors should carefully consider the benefits and risks of each treatment to make a joint decision for treating mHSPC.Clinical Trial Registration: NCT02677896 (ARCHES), NCT02446405 (ENZAMET) (ClinicalTrials.gov).

Economic burden of illness associated with localized prostate cancer in the United States.

Aim: Prior studies have established the economic burden of prostate cancer on society. However, changes to screening, novel therapies and increased use of active surveillance (AS) create a need for an updated analysis. Methods: A deterministic, decision-analytic model was developed to estimate medical costs associated with localized prostate cancer over 10 years. Results: 10-year costs averaged $45,957, $99,445 and $188,928 for low-, intermediate- and high-risk patients, respectively. For low-risk patients, AS 10-year costs averaged $33,912/patient, whereas definitive treatment averaged $49,667/patient. Despite higher failure rates in intermediate-risk patients, AS remained less costly than definitive treatment, with 10-year costs averaging $90,614/patient and $99,394/patient, respectively. Conclusion: Broader incorporation of AS, guided by additional prognostic tools, may mitigate this growing economic burden.

Health economic impact of a biopsy-based cell cycle gene expression assay in localized prostate cancer.

Background: Prior studies have established that broader incorporation of active surveillance, guided by additional prognostic tools, may mitigate the growing economic burden of localized prostate cancer in the USA. This study sought to further explore the potential of a particular gene expression-based prognostic tool to address this unmet need. Materials & methods: A deterministic, decision-analytic model was developed to estimate the economic impact of the Prolaris® test on a US commercial health plan. Results & conclusion: When adopted in patients classified by the American Urological Association as low or intermediate risk, the assay was projected to reduce costs by $1894 and $2129 per patient over 3 and 10 years, respectively, largely through the increased use of active surveillance.

Tissue-based multigene expression tests for pretreatment prostate cancer risk assessment: current status and future perspectives.

Prostate cancer is a highly prevalent disease with ample spectrum of aggressiveness and treatment options. Low-risk disease can be safely managed by nonintervention strategies, such as active surveillance; however, accurate risk assessment is warranted. Molecular tests have been developed and validated to complement standard clinicopathological parameters and help to improve risk stratification in prostate cancer. Herein, we review selected tissue-based assays, including genomic prostate score, cell cycle progression score and genomic classifier, with particular emphasis on their role in patient risk assessment in a pretreatment setting, in view of their current or potential utilization in active surveillance.

The emerging role of obesity, diet and lipid metabolism in prostate cancer.

Obesity is associated with an increased risk of a number of serious medical conditions, including cancer. As far as prostate cancer is concerned, obesity is associated with an increased risk of high-grade tumors, which is possibly related to lower androgen levels. Diet may also affect prostate cancer risk since countries with a higher dietary fat intake also present higher prostate cancer mortality rates. Interestingly, prostate cancer is associated with a number of metabolic alterations that may provide valuable diagnostic and therapeutic targets. This review explores the available clinical as well as biological evidence supporting the relationship between obesity, diet, alteration in metabolic pathways and prostate cancer.

Prognostic outlier genes for enhanced prostate cancer treatment.

AIM: To review the current landscape of outlier genes in the field of prostate cancer. METHODS: A comprehensive review was performed. RESULTS: Prostate cancer continues to be a significant worldwide health issue. In the era of personalized medicine, more emphasis is being placed on the ability to determine the timing, intensity and type of treatment, according to each patient's unique disease. Several commercial tests are available to determine the risk of aggressive prostate cancer based on genomic biomarkers and gene expression. Outlier genes represent a form of cancer classification that focuses on bimodal expression of a gene in a specific subset of patients. Outlier genes identified in prostate cancer include TMPRSS2-ERG, SPINK1, ScHLAP1, NVL, SMC4 and SQLE. CONCLUSION: Classifying patient prostate cancers by outlier genes may allow for individualized cancer therapies and improved cancer therapy outcomes.

Focal therapy as primary treatment for localized prostate cancer: definition, needs and future.

Focal therapy (FT) may offer a promising treatment option in the field of low to intermediate risk localized prostate cancer. The aim of this concept is to combine minimal morbidity with cancer control as well as maintain the possibility of retreatment. Recent advances in MRI and targeted biopsy has improved the diagnostic pathway of prostate cancer and increased the interest in FT. However, before implementation of FT in routine clinical practice, several challenges are still to overcome including patient selection, treatment planning, post-therapy monitoring and definition of oncologic outcome surrogates. In this article, relevant questions regarding the key steps of FT are critically discussed and the main available energy modalities are analyzed taking into account their advantages and unmet needs.

Imaging biobanks in oncology: European perspective.

Imaging biobanks as defined by the European Society of Radiology are "organised databases of medical images, and associated imaging biomarkers (radiology and beyond), shared among multiple researchers, linked to other biorepositories". Oncologic imaging biobanks are developed mainly for research purposes. These biobanks may be developed in academic centers, or with the support of industry. The awareness of their importance is gradually increasing in the oncologic community. It is difficult to determine which oncologic domain of research will benefit from the implementation of imaging biobanks. One of the most foreseeable applications could be the correlation between imaging phenotype and genotype. For this reason imaging biobanks should be embedded in wider biobanks networks, as for example the European-based Biobanking and BioMolecular resources Research Infrastructure.

Multiparametric MRI of the prostate gland: technical aspects.

With recent technological advancements, multiparametric MRI (mpMRI) has evolved into an important tool in the detection, localization and staging of prostate cancer. Optimization of image quality is paramount to mpMRI technique. While PI-RADS version 2 established guidelines for minimum technical parameters, there is no uniformity in mpMRI protocols across institutions. This review will discuss the key sequences that comprise a mpMRI exam. Technical factors that affect image quality, such as pre-exam patient preparation, magnet field strength, endorectal coil utilization and sequence parameters will also be examined. Several emerging technologies with potential to aid in the maturation of mpMRI will be introduced.