Laura Graham, M.D., a medical oncologist at the University of Colorado Anschutz Cancer Center, is asking these questions for prostate cancer patients: When should chemotherapy be incorporated into a patient’s care? Should it be added at all? In this new clinical trial, called “Triple Switch,” she is determined to find an answer.
“One of the hardest conversations I have is whether chemotherapy should be added upfront,” Graham said in an Anschutz news release. “Right now, I can’t give good information about who the right people are to get chemotherapy or how much benefit it actually adds.”
The Triple Switch clinical trial is prioritizing metastatic castration‑sensitive prostate cancer (adenocarcinoma) patients whose prostate-specific antigen (PSA) levels do not fall to zero after standard hormone treatments of androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI).
The goal, Graham said, is to get that PSA level to zero for this specific group of patients by determining whether adding chemotherapy is effective.
“But if [patients’ PSA levels don’t drop], then maybe this treatment will help them live longer,” Dr. Graham explained. “And if it doesn’t, we want to know that, too, so we’re not adding unnecessary side effects.”
The name “Triple Switch” comes from the trio of ADT, ARPI, and docetaxel chemotherapy, which has been the standard level of care. However, this trial is asking whether chemotherapy is necessary or beneficial.
“What we still don’t know is, if you’re already doing ADT and an ARPI, how much is the chemotherapy helping?” Dr. Graham said.
Castration-sensitive prostate cancer (CSPC) is an advanced type of prostate cancer that responds to hormone therapy, specifically keeping testosterone levels as low as castration levels (removal of testicles). When the cancer is metastatic, it means it has spread beyond the prostate. CSPC is not curable, but it is treatable.
Hormones like testosterone fuel prostate cancer cells. According to Johns Hopkins Medicine, hormone therapy for prostate cancer involves “depriving the cancer cells of this fuel by either blocking the production or action of androgen hormones.”
This is typically done with ADT, which reduces testosterone production, and an ARPI, which blocks cancerous cells from utilizing the body’s testosterone.
To be included in this trial, subjects must have received six to 12 months of ADT, as well as at least four months of an ARPI.
If they still have detectable PSA levels, they are eligible to be randomly selected for one of the two trial groups. One group will continue to be treated with solely hormone therapy, while the other will undergo six cycles of docetaxel chemotherapy.
The Triple Switch trial hopes to find out if patients who receive chemotherapy, along with hormone therapy, live longer. It also aims to determine whether they experience a better quality of life and whether their PSA levels change.
Dr. Graham wants to ensure that this trial is accessible to all participants and allows for virtual follow-ups.
“If we can remove barriers — like unnecessary travel — more people can access clinical trials,” Dr. Graham said. “That means better care and better outcomes.”
While the details of this trial do not specify race or ethnicity, the results of this study could greatly impact Black men who have been diagnosed with prostate cancer.
Black men are 1.5 times more likely to be diagnosed with prostate cancer and 2.4 times more likely to die from it, according to Amar Kishan, MD, a professor of radiation oncology at the David Geffen School of Medicine at UCLA, in a news release.
However, Dr. Kishan’s 2023 UCLA study revealed that Black men are 24 percent less likely than white men to be prescribed “novel” hormone therapy treatments like ARPIs, despite them experiencing positive outcomes from the treatment and having overall higher PSA levels.
Participation from Black men for this study is imperative, as the information gathered could not only benefit them but also benefit other Black prostate cancer patients and their decisions for personalized treatment plans moving forward.
Dr. Graham emphasizes that clinical trials provide doctors with the information they need to better serve their patients.
“My job isn’t to tell someone what to do,” Graham said. “My job is to give them the right information so they can make a choice that aligns with their values. But it’s hard to do that if I don’t have the right information. I’m hoping this trial will give us that information.”
If you meet the criteria for this trial, you can view its further requirements and details here at the University of Colorado Anschutz website.
You can also find it on ClinicalTrials.gov, where it is currently recruiting. This study has 310 locations across the United States and Canada.
By subscribing, you consent to receive emails from BlackDoctor.com. You may unsubscribe at any time. Privacy Policy & Terms of Service.
