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A pioneering prostate cancer study

For some patients, no treatment is best. Weighing the risks and benefits of watchful waiting.

To treat or not to treat? For many men with prostate cancer—particularly those with very early cancers or health issues that limit life expectancy—the answer is far from simple. 

To help patients and their physicians make the right decisions, the OHDSI Center’s Asieh Golozar is co-leading a study called PIONEER. Launched in 2019 by the European Network of Excellence for Big Data in Prostate Cancer, it involves researchers from 20 countries. 

According to Golozar, nearly 250,000 newly diagnosed patients in the U.S. each year must decide what treatment, if any, to pursue, depending on the stage of their disease and their age, overall health, and quality-of-life concerns. Some will choose surgery, radiation, hormonal therapy, or chemotherapy. These options can save and prolong lives but can have serious side effects, including infertility and impotence. 

Others, however, can safely postpone treatment. Younger men whose cancers are caught early or appear slow growing can forgo therapy and its side effects for years. Instead, they can undergo close monitoring, also known as “active surveillance,” until such time as their disease progresses. 

Golozar is particularly interested in yet another set of patients—men who may be best off forgoing treatment altogether. These are older and frailer. “Since these men are expected to die of other causes, the goal for them is to preserve quality of life by avoiding curative treatment,” she says. Their best option may be a strategy known as “watchful waiting.” 

Watchful waiting involves palliative interventions, which alleviate symptoms if and when they develop. “The goal is to spare men from overtreatment and unnecessary suffering,” Golozar says. But there’s a problem: Evidence about this population is limited, and there is “no good way to know” which men should go this route. 

Early in 2021, Golozar led a five-day study-a-thon to investigate the selection criteria, natural history, and outcomes of patients managed with watchful waiting. Members of the global OHDSI and EHDEN (European Health Data and Evidence Network) communities met virtually to identify data and map a strategy. 

Golozar led one group in characterizing patients and their diseases. She’s leading another to develop a prediction tool to sort out those individuals best suited for watchful waiting versus active surveillance. That effort draws on artificial intelligence expertise from Northeastern’s Institute for Experiential AI. 

Findings set to be published soon could have far-reaching impact. “We have the power of Big Data, standardized analytics, and a global network working to solve a high-priority question for clinicians and patients,” Golozar says. 

We have the power of Big Data, standardized analytics, and a global network working to solve a high-priority question for clinicians and patients. 

Asieh Golozar
Director of Clinical Research, OHDSI Center

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