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The LIBERTAS study: Advancing health equity for sexual and gender minorities in prostate cancer research

The first oncology program at the company that is intentionally transgender-inclusive, the LIBERTAS clinical study of patients with metastatic prostate cancer provides a pioneering, foundational guide for future research in this field.

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At Johnson & Johnson, a key element of our ambition to change the trajectory of health for humanity is to ensure that all patients have access to care. But it’s important to go a step further—we can make the biggest difference when we deliver affirming, culturally relevant care.

Health outcomes differ based on healthcare experience, particularly for historically underserved and marginalized populations. Just as geography, age, race, ethnicity, genetic background and disability can impact outcomes, so too can sex, gender identity and sexuality. Lesbian, gay, bisexual, transgender, queer, intersex, asexual and all sexually and gender diverse (LGBTQIA+) people—especially transgender people—have been and continue to be excluded from clinical research studies. When determining trends or outcomes, data on intersex individuals or gender identity are not routinely collected in clinical trials.,

The diagnosis and treatment of prostate cancer illustrates why this matters: According to the National Cancer Institute, more than 288,000 people in the United States will be diagnosed with prostate cancer this year, with the disease claiming nearly 35,000 lives annually. What we understand about prostate cancer to date is almost exclusively based on cisgender men. Any person who has a prostate is at risk for prostate cancer, yet we know very little about the outcomes of prostate cancer among gender-diverse patients.

As such, Johnson & Johnson Innovative Medicine is recruiting for LIBERTAS, a Phase 3 clinical study in patients with metastatic prostate cancer. Understanding clinical risk factors and the underlying biology of prostate cancer is key to improving care and treatment options when the disease has progressed.

We want to break new ground in understanding outcomes of prostate cancer in all patients and in particular those who are nonbinary, transgender or broadly part of the LGBTQIA+ community.
Mark Wildgust
Vice President of Oncology Global Medical Affairs

LIBERTAS is the first oncology program at the company to deliberately include transgender patients. It will evaluate whether patients who reach an undetectable level of prostate specific antigens (PSA)—which are chemical biomarkers for prostate cancer—can have their cancer therapy de-escalated to improve patient quality of life without increasing the risk of poor outcomes.

“We want to break new ground in understanding outcomes of prostate cancer in all patients and in particular those who are nonbinary, transgender or broadly part of the LGBTQIA+ community,” says Mark Wildgust, Vice President of Oncology Global Medical Affairs.

The development of LIBERTAS was led by Oncology Global Medical Affairs in partnership with various functions and teams, including Global Development and Open&Out, an employee resource group representing Johnson & Johnson LGBTQIA+ community members and allies.

External collaboration was also instrumental and included a scientific and patient advocate steering committee with individuals from diverse backgrounds; a partnership with Dr. Eli R. Green from Trans-Affirming Training & Consulting, who provided the LIBERTAS team and multiple stakeholders across Janssen R&D with transgender cultural competency training; and Fenway Health, which is developing diversity training materials for the LIBERTAS investigator site staff.

The goals of a groundbreaking study

Of the 1.6 million transgender people living in the United States, more than 400,000 will be diagnosed with cancer in their lifetime. However, there is still insufficient data available about various cancers that affect this community. A study published in JAMA attempts to begin quantifying the risk of prostate cancer for transgender women, and concludes that the disease occurs in 14 out of every 10,000 transgender women per year, compared to 33 per 10,000 cisgender men.

And while there may be a lower rate of prostate cancer in transgender people, a study published in 2021 found that transgender patients may have almost double the mortality rates of cisgender males. This may be because these populations have been overlooked and underserved, and therefore less likely to receive timely or optimal treatment for prostate cancer, says Neeraj Agarwal, M.D., FASCO, professor of medicine and senior director for clinical translation at the Huntsman Cancer Institute in Utah.

With recruitment underway, the LIBERTAS study will focus on patients with newly diagnosed metastatic prostate cancer with disease that remains sensitive to blocking androgen receptor signaling. Currently, a Johnson & Johnson prostate cancer therapy is approved for this type of cancer in combination with androgen deprivation therapy (ADT).

ADT is a common treatment for patients with hormone-sensitive prostate cancer because it lowers levels of androgens to stop the growth of cancer cells. But ADT has been linked to long-term health risks and adverse side effects, such as hot flashes and cognitive impairment. Participants will be evaluated to assess whether an androgen receptor signaling inhibitor alone can keep their cancer from advancing, thereby potentially allowing patients to safely stop taking ADT. As Agarwal, who is a LIBERTAS study investigator, explains, “We want to determine if going off ADT, or not, will improve quality of life without compromising efficacy of treatment.”

With the inclusion of transgender individuals who may be receiving feminizing gender-affirming care or ADT, de-escalating therapy must be approached with deliberate care. ADT is an important therapeutic component of gender-affirming hormone therapy (GAHT) for some nonbinary and transgender women who are medically transitioning, since it suppresses testosterone and reduces the appearance of unwanted masculine secondary sex characteristics like facial hair and a deep voice.

“In the transgender community, ADT is considered lifesaving medication,” says Shir Netanel, Associate Director of Patient Advocacy and Clinical Trials Advocacy in Global Medical Affairs Oncology at Johnson & Johnson. “We had to think about how we could create an exception for this underserved patient population to allow them to enroll in the study while still achieving our scientific goal.” That exception would be to let participants remain on ADT as part of their gender-affirming care.

An illustrating of multi-colored stick figures standing in a crowd with confetti falling on them

At J&J, we are rethinking oncology clinical research protocols using inclusive language that reflects all eligible patients. Learn more here.

Working toward health equity in the long run

The LIBERTAS study is an inclusive prostate cancer clinical study protocol that has been strategically designed to include individuals of all genders, including transgender and nonbinary individuals. The protocol utilizes inclusive language and broad eligibility criteria, focusing solely on the prostate cancer diagnosis to define the patient population, irrespective of gender identity.

This pioneering protocol provides a foundational guide for future studies in this field.

In addition to gendered binary medical language, a lack of Sexual Orientation and Gender Identity (SOGI) data collection is another barrier in LGBTQIA+ research, contributing to significant health disparities. The LIBERTAS study has established the foundation to collect SOGI data across future Johnson & Johnson studies. It will serve as a model to ensure representation, while also measuring the impact of our therapies for sexual and gender minorities.

“Within clinical studies, you want as much diversity as possible. There are so many factors that affect how a drug interacts within all kinds of humans,” says Scout, Ph.D., executive director of the National LGBT Cancer Network and member of the Johnson & Johnson prostate cancer patient advocacy steering committee. “Having a preponderance of one type of human affects results. And we want to give the LGBTQIA+ population equal access to the cutting-edge treatments being studied.”

Ultimately, understanding the best treatment options for all people, including transgender people, begins with a foundation of truly inclusive clinical research studies.

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