PCF-funded investigators believe a whole-food, plant-based diet may make a big difference for men who are overweight before they even start androgen deprivation therapy (ADT) – a form of treatment that lowers a man’s androgen levels and, itself, is linked to weight gain. (Read more about the study here.)
Although the main endpoint of the study is weight loss – “a simple thing to measure,” notes Weill Cornell medical oncologist David Nanus, M.D. – “there’s a lot more to it.” Nanus is Principal Investigator of this study, along with medical oncologists Channing Paller, M.D., of Johns Hopkins, and Mark Stein, M.D., of Columbia University.
The study’s investigators will also be looking at markers in the blood to see if the level of inflammation changes. (Inflammation is linked to many chronic illnesses, such as heart disease and even cancer.) They will measure cholesterol, and also carotenoids – pigments naturally found in plants that are “an indirect way of measuring how much fruit and vegetables you are eating; it’s a way to tell if you’re sticking to the diet or not.” Men will also complete questionnaires about their diet and quality of life.
In collaboration with PCF-funded Johns Hopkins scientist Karen Sfanos, Ph.D., the participants’ stool samples will be analyzed, looking for metabolic changes and alterations in the microbiome, the population of gut bacteria. Men in the study will also have three DEXA scans to measure bone density and body fat. Although blood and stool specimens will be taken throughout the study, “unfortunately, we can’t measure many of the blood and stool markers until the last patient has completed the study,” Nanus explains. “It has to be batch-measured – run at the same time for quality control, to make sure the standards are the same in every patient, and from patient to patient.”
That said, “we did do some preliminary analysis with the first 40 patients in the trial,” says Nanus, “and we have seen significant differences. There’s no question: we could see that patients who are in the treatment arm lose weight, feel good, and keep going longer. Not everybody loves the (prepared) food.” Some men do love it. Some men, after the six months, “will go back to including a little fish and the occasional meat, and we’re okay with that.”
One man “went off the wagon over Christmas, then went back on. He didn’t gain any weight over the holidays, and went back to the diet.” Another man, a patient of Nanus’s, came late to the diet. “He didn’t want to give up his beer.” But he also kept gaining weight. He started the whole food, plant-based diet and lost 20 pounds. “We have a number of men who just stay on the diet after the six months. It changes their lives,” and also the lives of the spouses or partners – many of whom “go on the journey with them,” he notes.
“PCF has been incredibly supportive,” says Nanus. “PCF and Michael Milken recognize that nutrition is critical, and that’s why they funded this trial.” Nanus went on the diet himself for one month with home-delivered meals – “so I’m not asking patients to do something I wouldn’t do. It did change the way I eat, and I lost 10 pounds over that month!”
Living with the effects of ADT is a challenge that didn’t even exist a couple of decades ago. “It used to be that we didn’t worry about medical issues like elevated blood sugar in our patients with metastatic prostate cancer, because the men weren’t going to live that long,” says Nanus. “Today, many men with metastatic prostate cancer are going to live for many years, so we have to address their survivorship – not just surviving cancer, but surviving with cancer.”
Nanus expects to complete enrollment in the trial this fall, and to analyze the data within the next year. If you are interested in learning more about the trial, go to clinicaltrials.gov. Note: This is an East Coast-based trial. Participants must be able to travel either to New York City or Baltimore.
