Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Perspective
  • Published:

Clinical

The imperative for clinical trial diversity: Perspectives in the context of prostate-specific membrane antigen-targeted imaging

Prostate Cancer and Prostatic Diseases volume 26, pages 511–515 (2023)Cite this article

Subjects

Prostate-specific membrane antigen (PSMA)-targeted scans represent an opportunity to improve prostate cancer management. Existing imaging modalities in prostate cancer, including CT/MRI scans, bone scintigraphy, and 18-Fluciclovine scans all have significant limitations in their ability to detect prostate cancer metastases [1]. Thus, PSMA-targeted scans, which use radioactive tracers to detect PSMA antigen on prostate cancer cells, generated significant excitement due to their comparatively high sensitivity and specificity for detecting prostate cancer, and ability to influence staging and management [2,3,4,5]. PSMA-targeted scans may improve patient outcomes by allowing earlier intervention for locoregional recurrence or even distant metastases, which is particularly significant in light of increasing evidence demonstrating survival benefits from metastasis-directed therapy in prostate cancer (such as the ORIOLE and STOMP trials) [6, 7]. Currently, two PSMA-targeted imaging drugs (68Ga-PSMA-11 in December 2020 and 18F-DCFPyL) have been approved by the Food & Drug Administration (FDA) for use in initial staging and workup of biochemical recurrence in patients with prostate cancer [8, 9].

However, PSMA-targeted scans raise ethical questions about equitable implementation. Compared with white patients, patients with prostate cancer from traditionally underrepresented populations (including racial and ethnic minority groups) currently experience disparities in prostate cancer incidence, diagnosis, treatment, and outcomes [10]. In the US, Black men are 1.5 times more likely to be diagnosed with prostate cancer than white men, and are more than twice as likely to die of the disease [10, 11]. These patients also experience significant disparities in access to, and quality of, treatment [12,13,14,15]. These disparities extend internationally, such that low and middle-income countries, particularly those in the Caribbean and Africa, have the highest estimated mortality rates for prostate cancer [16]. While the literature focuses largely on disparate access to prostate cancer treatment modalities, we are increasingly acknowledging how these disparities extend to diagnostic imaging [17, 18]. As such, it is important to explicitly acknowledge and address disparate access to PSMA-targeted scans to prevent perpetuating or exacerbating these existing prostate cancer disparities.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

Fig. 1: Proposed strategies to address participant diversity in prostate specific membrane antigen-associated clinical trials.

Data availability

Data sharing is not applicable to this manuscript as no new data were created or analyzed in this study.

References

  1. Turpin A, Girard E, Baillet C, Pasquier D, Olivier J, Villers A, et al. Imaging for metastasis in prostate cancer: a review of the literature. Front Oncol. 2020;10:55 https://www.frontiersin.org/article/10.3389/fonc.2020.00055.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Hofman MS, Lawrentschuk N, Francis RJ, Tang C, Vela I, Thomas P, et al. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet. 2020;395:1208–16.

    Article  CAS  PubMed  Google Scholar 

  3. Abghari-Gerst M, Armstrong WR, Nguyen K, Calais J, Czernin J, Lin D, et al. A comprehensive assessment of 68Ga-PSMA-11 PET in biochemically recurrent prostate cancer: Results from a prospective multi-center study in 2005 patients. J Nucl Med. 2021;63:567–72.

    Article  PubMed  Google Scholar 

  4. Pienta KJ, Gorin MA, Rowe SP, Carroll PR, Pouliot F, Probst S, et al. A Phase 2/3 prospective multicenter study of the diagnostic accuracy of prostate specific membrane antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY). J Urol. 2021 ;206:52–61.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Morris MJ, Rowe SP, Gorin MA, Saperstein L, Pouliot F, Josephson D, et al. Diagnostic performance of 18F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR Phase III, Multicenter Study. Clin Cancer Res. 2021;27:3674–82.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  6. Phillips R, Shi WY, Deek M, Radwan N, Lim SJ, Antonarakis ES, et al. Outcomes of observation vs stereotactic ablative radiation for oligometastatic prostate cancer: The ORIOLE Phase 2 randomized clinical trial. JAMA Oncol. 2020;6:650–9.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Ost P, Reynders D, Decaestecker K, Fonteyne V, Lumen N, De Bruycker A, et al. Surveillance or metastasis-directed therapy for oligometastatic prostate cancer recurrence: a prospective, randomized, multicenter Phase II trial. J Clin Oncol. 2018;36:446–53.

    Article  CAS  PubMed  Google Scholar 

  8. Office of the Commissioner. FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer. FDA; 2020. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-psma-targeted-pet-imaging-drug-men-prostate-cancer.

  9. Center for Drug Evaluation and Research. FDA approves second PSMA-targeted PET imaging drug for men with prostate cancer. FDA; 2021. Available from: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-second-psma-targeted-pet-imaging-drug-men-prostate-cancer.

  10. Vince RA, Jamieson S, Mahal B, Underwood W. Examining the Racial Disparities in Prostate Cancer. Urology. 2022;163:107–11.

    Article  PubMed  Google Scholar 

  11. Chowdhury-Paulino IM, Ericsson C, Vince R, Spratt DE, George DJ, Mucci LA. Racial disparities in prostate cancer among black men: epidemiology and outcomes. Prostate Cancer Prostatic Dis. 2022;25:397–402.

    Article  PubMed  Google Scholar 

  12. Jain B, Yamoah K, Lathan CS, Muralidhar V, Mahal BA, Nguyen PL, et al. Racial disparities in treatment delay among younger men with prostate cancer. Prostate Cancer Prostatic Dis. 2022;25:590–2.

    Article  PubMed  Google Scholar 

  13. Zavala VA, Bracci PM, Carethers JM, Carvajal-Carmona L, Coggins NB, Cruz-Correa MR, et al. Cancer health disparities in racial/ethnic minorities in the United States. Br J Cancer. 2021;124:315–32.

    Article  PubMed  Google Scholar 

  14. Dee EC, Arega MA, Yang DD, Butler SS, Mahal BA, Sanford NN, et al. Disparities in refusal of locoregional treatment for prostate adenocarcinoma. JCO Oncol Pract. 2021;17:e1489–501.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Dee EC, Muralidhar V, Arega MA, Kishan AU, Spratt DE, Dess RT, et al. Factors influencing noncompletion of radiation therapy among men with localized prostate cancer. Int J Radiat Oncol*Biol*Phys. 2021;109:1279–85.

    Article  PubMed  Google Scholar 

  16. Culp MB, Soerjomataram I, Efstathiou JA, Bray F, Jemal A. Recent global patterns in prostate cancer incidence and mortality rates. Eur Urol. 2020;77:38–52.

    Article  PubMed  Google Scholar 

  17. Waite S, Scott J, Colombo D. Narrowing the gap: imaging disparities in radiology. Radiology 2021;299:27–35.

    Article  PubMed  Google Scholar 

  18. Miles RC, Onega T, Lee CI. Addressing potential health disparities in the adoption of advanced breast imaging technologies. Acad Radiol. 2018;25:547–51.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Madan RA, Mena E, Lindenberg L, Choyke PL. With New Technology Comes Great Responsibility: Prostate-Specific Membrane Antigen Imaging in Recurrent Prostate Cancer. J Clin Oncol. 2022;40:3015–9.

    Article  PubMed  Google Scholar 

  20. Abraham P, Bishay AE, Farah I, Williams E, Newton IG. Reducing health disparities in radiology through social determinants of health: lessons from the COVID-19 pandemic. Acad Radiol. 2021;28:903–10.

    Article  PubMed  Google Scholar 

  21. Dee EC, Pierce LJ, Winkfield KM, Lam MB. In pursuit of equity in cancer care: Moving beyond the Affordable Care Act. Cancer 2022;128:3278–83.

    Article  PubMed  Google Scholar 

  22. Dess RT, Hartman HE, Mahal BA, Soni PD, Jackson WC, Cooperberg MR, et al. Association of black race with prostate cancer–specific and other-cause mortality. JAMA Oncol. 2019;5:975–83.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Spratt DE, Osborne JR. Disparities in castration-resistant prostate cancer trials. J Clin Oncol. 2015;33:1101–3.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Bucknor MD, Lichtensztajn DY, Lin TK, Borno HT, Gomez SL, Hope TA. Disparities in PET imaging for prostate cancer at a tertiary academic medical center. J Nucl Med. 2021;62:695–9.

    Article  CAS  PubMed  Google Scholar 

  25. Zhai Z, Zheng Y, Li N, Deng Y, Zhou L, Tian T, et al. Incidence and disease burden of prostate cancer from 1990 to 2017: Results from the Global Burden of Disease Study 2017. Cancer 2020;126:1969–78.

    Article  PubMed  Google Scholar 

  26. Czernin J, Adams T, Calais J. More unacceptable denials: now It’s PSMA-targeted PET/CT imaging. J Nucl Med. 2022;63:969–70.

    Article  PubMed  Google Scholar 

  27. Taplin SH, Anhang Price R, Edwards HM, Foster MK, Breslau ES, Chollette V, et al. Introduction: Understanding and influencing multilevel factors across the cancer care continuum. JNCI Monogr. 2012;2012:2–10.

    Article  Google Scholar 

  28. Shea L, Pesa J, Geonnotti G, Powell V, Kahn C, Peters W. Improving diversity in study participation: Patient perspectives on barriers, racial differences and the role of communities. Health Expect. 2022;25:1979–87.

    Article  PubMed  PubMed Central  Google Scholar 

  29. De Las Nueces D, Hacker K, DiGirolamo A, Hicks LS. A systematic review of community-based participatory research to enhance clinical trials in racial and ethnic minority groups. Health Serv Res. 2012;47:1363–86.

    Article  PubMed Central  Google Scholar 

  30. Baquet CR, Bromwell JL, Hall MB, Frego JF. Rural community–academic partnership model for community engagement and partnered research. Prog Community Health Partnersh. 2013;7:281–90.

    Article  PubMed  PubMed Central  Google Scholar 

  31. Johnson DA, Joosten YA, Wilkins CH, Shibao CA. Case study: community engagement and clinical trial success: outreach to African American women. Clin Transl Sci. 2015;8:388–90.

    Article  PubMed  PubMed Central  Google Scholar 

  32. Katz ML, Tatum C, Dickinson SL, Murray DM, Long-Foley K, Cooper MR, et al. Improving colorectal cancer screening by using community volunteers. Cancer 2007;110:1602–10.

    Article  PubMed  Google Scholar 

  33. Christy SM, Davis SN, Williams KR, Zhao X, Govindaraju SK, Quinn GP, et al. A community-based trial of educational interventions with fecal immunochemical tests for colorectal cancer screening uptake among blacks in community settings. Cancer 2016;122:3288–96.

    Article  PubMed  Google Scholar 

  34. Cole H, Thompson HS, White M, Browne R, Trinh-Shevrin C, Braithwaite S, et al. Community-based, preclinical patient navigation for colorectal cancer screening among older black men recruited from Barbershops: The MISTER B Trial. Am J Public Health. 2017;107:1433–40.

    Article  PubMed  PubMed Central  Google Scholar 

  35. Williams LB, Looney SW, Joshua T, McCall A, Tingen MS. Promoting community awareness of lung cancer screening among disparate populations: results of the cancer-community awareness access research and education project. Cancer Nurs. 2021;44:89.

    Article  PubMed  Google Scholar 

  36. Menendez R. S.2706 - 117th Congress (2021-2022): DIVERSE Trials Act. 2021. Available from: http://www.congress.gov/.

  37. Unger JM, Hershman DL, Till C, Minasian LM, Osarogiagbon RU, Fleury ME, et al. “When Offered to Participate”: A systematic review and meta-analysis of patient agreement to participate in cancer clinical trials. J Natl Cancer Inst. 2021;113:244–57.

    Article  PubMed  Google Scholar 

  38. Institute of Medicine (US) Committee on Routine Patient Care Costs in Clinical Trials for Medicare, Aaron HJ, Gelband H Paying for Patient Care in Clinical Trials. Extending Medicare Reimbursement in Clinical Trials. National Academies Press (US); 2000. Available from: http://www.ncbi.nlm.nih.gov/books/NBK225267/.

  39. Iagaru A, Franc B. Disparities in PET imaging of prostate cancer at a tertiary academic medical center. J Nucl Med. 2021;62:747–8.

    Article  PubMed  Google Scholar 

  40. Fact Sheet: White House Announces Initial Steps for Reignited Cancer Moonshot. The White House. Available from: https://www.whitehouse.gov/ostp/news-updates/2022/03/17/fact-sheet-white-house-announces-initial-steps-for-reignited-cancer-moonshot/.

  41. Sultan DH, Gishe J, Hanciles A, Comins MM, Norris CM. Minority use of a National Cancer Institute-Designated Comprehensive Cancer Center and Non-specialty Hospitals in Two Florida regions. J Racial Ethn Health Dispar. 2015;2:373–84.

    Article  Google Scholar 

  42. Tikkanen RS, Woolhandler S, Himmelstein DU, Kressin NR, Hanchate A, Lin MY, et al. Hospital payer and racial/ethnic mix at private academic medical centers in Boston and New York City. Int J Health Serv. 2017;47:460–76.

    Article  PubMed  PubMed Central  Google Scholar 

  43. https://nucleus.iaea.org/sites/accelerators Cyclotrons used for radionuclide production. Nucleus.

  44. Zippel C, Ronski SC, Bohnet-Joschko S, Giesel FL, Kopka K. Current Status of PSMA-radiotracers for prostate cancer: data analysis of prospective trials listed on ClinicalTrials.gov. Pharmaceuticals 2020;13:12.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  45. Calais J, Ceci F, Eiber M, Hope TA, Hofman MS, Rischpler C, et al. 18F-fluciclovine PET-CT and 68Ga-PSMA-11 PET-CT in patients with early biochemical recurrence after prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial. Lancet Oncol. 2019;20:1286–94.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

Download references

Funding

ECD is funded in part through the Cancer Center Support Grant from the National Cancer Institute (P30 CA008748).

Author information

Authors and Affiliations

  1. Harvard Medical School, Boston, MA, USA

    Hae Lin Cho

  2. Departments of Radiation Oncology and Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Subha Perni

  3. Department of Radiation Oncology, Brigham and Women’s Hospital and Dana Farber Cancer Institute, Boston, MA, USA

    Anthony V. D’Amico

  4. Department of Radiation Oncology, Moffitt Cancer Center & Research Institute, Tampa, FL, USA

    Kosj Yamoah

  5. Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA

    Edward Christopher Dee

Authors
  1. Hae Lin Cho
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Subha Perni
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Anthony V. D’Amico
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Kosj Yamoah
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Edward Christopher Dee
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

HC drafted the initial manuscript. All authors (HC, SP, AVD, KY, ECD) made substantial contributions to the preparation and revision of the manuscript and approved the final version of the manuscript.

Corresponding author

Correspondence to Hae Lin Cho.

Ethics declarations

Competing interests

KY has a consulting or advisory role with Janssen Research & Development LLC and MyCareGortithm LLC. The authors have no other conflicts of interest to declare.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Cho, H.L., Perni, S., D’Amico, A.V. et al. The imperative for clinical trial diversity: Perspectives in the context of prostate-specific membrane antigen-targeted imaging. Prostate Cancer Prostatic Dis 26, 511–515 (2023). https://doi.org/10.1038/s41391-023-00657-3

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41391-023-00657-3

Search

Advanced search

Quick links