A New Phase II Trial To Begin To Evaluate A Potential Treatment For ADT Related Hot Flashes

One almost universal experience that men on hormone therapy (ADT) experience is hot flashes.  Hot flashes are characterized by men on ADT as their having the subjective sensation of a rise in the temperature in their face and trunk along with the widening of blood vessels in the skin known as cutaneous vaso-dilatation, predominantly in the face, throat, and extremities, usually followed by profuse sweating.  Hot flashes that are related to prostate cancer ADT treatment tend to persist over time, with the same frequency and intensity throughout the entire treatment course.

Hot flashes are not the only side effect of ADT, but it is the side effect that is most complained about. Yet, there is no effective or approved treatment for hot flashes.  Mostly, men on ADT just have to take a few unapproved and not effective medications, “grin and bear it” and are told to stop complaining.

There is a new phase II clinical trial, set to begin shortly, to evaluate a new investigational drug that hopefully will treat ADT caused hot flashes.  This is a phase II trial that means that all participants will receive the investigation treatment.

The trial will evaluate an investigational treatment called VERU-944 (APP-944) for the treatment of hot flashes for men being on hormone therapy (ADT) for prostate cancer.

The announcement comes after a Pre-Investigational New Drug Application meeting was held with the U.S. Food and Drug Administration (FDA) and Veru Healthcare.

According to a press release, Robert H. Getzenberg, PhD, executive vice president for clinical development at Veru Healthcare said, “We had a very positive meeting with FDA during which we received clarification on a path forward for the clinical development of VERU-944,”

If approved the investigational treatment VERU-944 has the potential to be the first FDA approved medication for ADT related hot flashes. If it works it would be a boon for so many of us on hormone therapy.

Clinical trials like this one can provide a man with a path to receiving a treatment long before it gets approved by the FDA and for no financial cost. Given that there are no other viable treatments, if you are struggling with hot flashes, you should discuss with your doctor the possibility of participating in this trial.

According to the company, they expect to be able to begin a Phase III trial in the second half of 2018.  Of course, this schedule is directly tied to the results of this trial. 

At this moment this phase II trial is not yet listed on the government clinical trial web page, www.clinicaltrials.gov.  I suggest that you check back in a week or two if you are interested in participating.

Joel T. Nowak, MA, MSW wrote this Post.  Joel is the CEO/Executive Director of Cancer ABCs.  He is a Cancer Thriver diagnosed with 5 primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma and a rare cancer, Appendiceal Cancer.