For decades, researchers, healthcare professionals, patients and their loved ones have come together to advance treatment and care for people diagnosed with prostate cancer. Clinical studies have been the centerpiece for collaboration across the entire disease continuum, from early, localized disease to late-stage, metastatic prostate cancer. Yet, the LGBTQIA+ (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, and Asexual +) community, and especially transgender individuals, have historically been excluded from clinical research programs. At Janssen Oncology, we are rethinking clinical research protocols to ensure all eligible patients are able to participate.
The LGBTQIA+ community is a growing population that disproportionately faces a wide range of health disparities. For example, of the 1.6 million transgender people living in the United States, more than 400,000 will be diagnosed with cancer in their lifetime.1 Prostate cancer, in particular, may be even more common among transgender women and nonbinary people than case reports suggest according to more than 20 years of data from the U.S. Department of Veterans Affairs.2 Between January 2018 and July 2022, 141,661 articles were published on PubMed reporting interventional clinical study results. Of these, only 107 (0.08 percent) articles reported participation of transgender or non-binary patients with the majority of these focusing on HIV and mental health with less emphasis on other areas, including cancer.3
Health disparities may result from many factors for this community including a delay in medical care or treatment due to systemic healthcare barriers, systemic bias, marginalization, and discrimination by healthcare providers. Disparities may also result from systemic barriers in LGBTQIA+ research, including a lack of Sexual Orientation and Gender Identity (SOGI) data collection and reporting, and gendered binary medical language that excludes gender diverse patients in clinical studies.4
The lack of inclusion of SOGI data in clinical studies makes it difficult to determine if the LGBTQIA+ population is represented in clinical studies. Additionally, without SOGI data, it is unclear whether treatments, safety and outcomes are different for LGBTQIA+ patients with prostate cancer.
Moreover, the way many clinical study protocols are generally written is inherently non-inclusive. For example, terms such as sex and gender are broadly used interchangeably by the medical community,5 but it is not always clear whether protocols are referencing study participant sex assigned at birth or gender identity, which are distinctly different but equally as important for evaluating the safety and efficacy of investigational drugs being studied. For example, many prostate cancer protocols are written with language that does not reflect the fact that transgender women or non-binary individuals who are assigned male at birth can have prostate cancer. Protocol language needs to be more specific and inclusive, to ensure health equity and a comprehensive evaluation of prostate cancer risks for any patient who may be diagnosed during their lifetime – regardless of their sex and gender.
At Janssen, we are making strides to improve our ways of working to implement the more inclusive clinical study conduct described above. As a testament to this commitment, we recently initiated our first degendered and transgender-inclusive oncology clinical study protocol for LIBERTAS: A Phase 3, Open-label, Randomized, Prospective Study of an Intermittent Androgen-Deprivation Therapy (ADT) Approach with Apalutamide Monotherapy in Participants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC), which will serve as a foundational guide for future study protocols. The LIBERTAS study will collect and report SOGI data to illuminate disparities that exist for LGBTQIA+ patients with prostate cancer.
Through this study, we hope to pioneer innovative clinical research that removes barriers and ensures diverse representation in clinical studies. In addition to a comprehensive approach to ensure inclusion of LGBTQIA+ participants, the LIBERTAS study diversity plan will also address prostate cancer disparities in Black and African American people with prostate cancer, and patients with disabilities unrelated to their disease or treatments, who have also traditionally been excluded and underrepresented in cancer clinical trials.
This important effort would not be possible without strong internal partnership between the LIBERTAS study team, the Johnson & Johnson Open&Out LGBTQIA+ employee led resource group, and the Diversity, Equity, and Inclusion in Clinical Trials (DEICT) Team. External collaboration also continues to be instrumental, and includes scientific and patient advocate steering committees comprised of individuals from diverse backgrounds, a partnership with Dr. Eli R Green (He/They) 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 study will be conducted in nine countries and is expected to start enrolling in September 2023. More information can be found at Clinicaltrials.gov.
As an important example Janssen’s commitment to advancing sexual and gender minority health equity in cancer care, my hope is that this study, and our concerted efforts, will serve as a catalyst for the industry to make clinical studies more inclusive for all patients.
1 Alpert AB, Brewer JR, Adams S, Rivers L, Orta S, et. al. Addressing barriers to clinical trial participation for transgender people with cancer to improve access and generate data. J Clin Oncol. 2023 Apr 1;41(10):1825-1829. doi: 10.1200/JCO.22.01174. Epub 2022 Oct 27. PMID: 36302204; PMCID: PMC10082226.
2 Nik-Ahd F, De Hoedt A, Butler C, Anger JT, et al. Prostate Cancer in Transgender Women in the Veterans Affairs Health System, 2000-2022. JAMA. 2023 Jun 6;329(21):1877-1879. doi: 10.1001/jama.2023.6028. PMID: 37119522; PMCID: PMC10148974.
3 Round R, Gokool N, Manica G, Paschall L, er al. Improving access for and experience of transgender and non-binary patients in clinical research: Insights from a transgender patient focus group and targeted literature reviews. Contemporary Clinical Trials. Volume 131, 2023, 107243, ISSN 1551-7144. https://doi.org/10.1016/j.cct.2023.107243.
4 Kamen CS, Pratt-Chapman ML, Meersman SC, et al: Sexual orientation and gender identity data collection in oncology practice: Findings of an ASCO survey. J Oncol Pract. May 23, 2022.
5 Schabath MB, Blackburn CA, Sutter ME, et al: National survey of oncologists at National Cancer Institute–designated comprehensive cancer centers: Attitudes, knowledge, and practice behaviors about LGBTQ patients with cancer. J Clin Oncol 37:547-558, 2019.
July 20, 2023
