Video: VERU-944 to Improve Hot Flashes in Men With Advanced Prostate Cancer | Learn Clinical Trials

Learn Clinical Trials | Transcription

(NOTE: THIS TRIAL STOPPED RECRUITING 1/22/20)

Hi, I'm Dr. Scholz. Let's talk about clinical trials for prostate cancer.

Clinical trials are a comparison of different approaches to managing specific problems that we encounter in the prostate cancer realm. The clinical trial that I want to discuss today uses a new medicine called VERU-944 to try and reduce hot flashes in men who are taking Lupron. This problem with hot flashes is really an unsolved problem. There are a lot of different agents out there and none of them work consistently and oftentimes they have side effects that are undesirable. 

This particular trial is looking at this new agent VERU-944 in three different doses. About 120 men are going to be studied and only 30 of them will get placebo. The remaining 90 patients will all get varying doses of this new agent, VERU-944. VERU-944 is an estrogen derivative. It's a synthetic estrogen that has more targeted effects on hot flashes, but it doesn't have the same propensity for breast enlargement that is so common with the use of regular estrogen. So it's hopeful that this convenient oral agent will reduce hot flashes without creating breast enlargement. 

It's believed that hot flashes occur because of a lack of estrogen in men. People think of estrogen as a female hormone, but men have small amounts of estrogen which comes from testosterone. So when testosterone is eliminated by Lupron, estrogen levels in the blood drop as well and it's thought that that deficiency of estrogen is the problem inciting these excess hot flashes. Hot flashes occur in probably two-thirds of men who are on Lupron. They're really quite severe in about a third of men (and quite severe is defined by men who are waking up at night, can't get through the night, where the hot flashes are so uncomfortable they're really disconcerting and create anxiety in people). 

Hot flashes do respond well to things like estrogen. Estrogen patches are popular, but enlargement of the breasts is a real issue and so if that problem occurs, the treatment has to be stopped. Oral estrogens can cause problems with blood clots and therefore shouldn't be used without some sort of a blood thinner at the same time. 

Other agents are on the market like antidepressants such as Effexor and that may also help smooth out mood issues that can be a problem for men who are on Lupron, but Effexor has problems sometimes with fatigue and it can also cause some blunting of emotional response. So, it is a consideration, but Effexor only works about half the time in men that have hot flashes. 

Another popular approach, historically, is progesterone. Progesterone has hormonal effects that reduce hot flashes, but the problem with progesterone is it can be converted into testosterone and testosterone drives prostate cancer. So we've gotten away from using progesterone even though it is very effective when you give progesterone for hot flashes. 

A third medicine that has been considered for hot flashes, Neurontin (or gabapentin), was originally approved for seizure problems and it's also used for people who have neuropathy, and it will reduce hot flashes perhaps half of the time in people that take that agent. The issue with Neurontin is that as an anti-seizure medicine, it tends to cause fatigue and slowing of mentation and people often don't feel very good on it. 

So, there's a really big need for an effective agent that can reduce hot flashes without causing breast enlargement and we're hopeful that VERU-944 is that agent. So, by participating in this trial, not only can you help further the understanding on the efficacy of this medication, but it's quite likely to help with the needs that you have right now with excess hot flashes. If you'd like more information about this clinical trial, follow the instructions that will be provided on the screen.