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Open AccessUrology PracticeHealth Policy1 Jan 2025

Identification of Factors Affecting the Accrual of Black Males Into Prostate Cancer Clinical Trials in the United States

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Abstract

Introduction:

Black males have the highest incidence and mortality rates from prostate cancer of any racial group in the United States, yet are underrepresented in prostate cancer clinical trials.

Methods:

The Prostate Health Education Network surveyed its members about experiences regarding prostate cancer clinical trials and explored reasons for lack of participation. Black males residing in the United States with a diagnosis of prostate cancer were eligible to participate.

Results:

Of 480 members contacted, 115 (24.0%) completed the survey. Respondents were diverse in age, geography, education, and socioeconomic status, and 58 (50.4%) had a family history of prostate cancer; 12 of 115 (10.4%) had participated in a prostate cancer clinical trial. The most common reasons for nonparticipation (N = 89) included not being asked (55.1%) and a lack of information about risks and benefits (13.5%). No respondents cited lack of trust in the healthcare system based on personal experience, although 2 (2.2%) cited the Tuskegee study. Factors that would influence future decisions around trial participation included whether respondents (N = 99) perceived the treatment or diagnostic option to be effective for themselves (54.5%), to have the potential to advance medical science (45.5%), and to have minimal side effects (44.4%).

Conclusions:

This survey of Prostate Health Education Network members found that the principal reason for Black males not participating in prostate cancer clinical trials was that they were not being asked. This highlights an unmet need for stronger collaboration between patients, health professionals, the pharmaceutical industry, and clinical trial investigators to address barriers to Black males enrolling in prostate cancer clinical trials.

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Black males are more likely than White males to be diagnosed with prostate cancer and have the highest death rate from prostate cancer of any racial group in the United States.1 Prostate cancer may also be more aggressive in Black males, with a higher rate of metastasis at diagnosis.2,3 However, Black males are underrepresented in prostate cancer clinical trials4-6; of 59 global trials (51 phase 3/4 treatment trials, 4 phase 3/4 prevention trials, and 4 screening trials) which enrolled participants between 1987 and 2016, Black or African American males represented 6.7%, 8.5%, and 0.5% of participants, respectively, whereas White males represented 83.4%, 84.6%, and 97.5%, respectively.5

UPJ Insight

  • Study Need and Importance

  • Black males in the United States have the highest incidence and mortality rates of prostate cancer of any racial group, yet are considerably underrepresented in prostate cancer clinical trials. The Prostate Health Education Network (PHEN) surveyed its members to explore potential reasons for this.

  • What We Found

  • The survey was completed by 115 PHEN members; all were Black males residing in the United States with a diagnosis of prostate cancer and were diverse in age, geography, education, and socioeconomic status. Approximately 50% had a family history of prostate cancer, and ∼10% had participated in a prostate cancer clinical trial. The most common reason for nonparticipation in prostate cancer clinical trials was not being asked (49/89 respondents, 55%); very few respondents cited lack of trust in the health care system due to either personal experience (0%) or historical treatment of Black patients in clinical trials (2/89 respondents, 2%). Desirable characteristics that would most influence the future participation of respondents in a clinical trial included a treatment or diagnostic option that would be effective for them, the opportunity to contribute to medical science, and minimal potential side effects.

  • Limitations

  • Respondents were likely to already be knowledgeable about prostate cancer and clinical research through interactions with PHEN, so may not fully represent the wider Black population with prostate cancer.

  • Interpretation for Patient Care

  • There is a need for stronger interaction between patients, health professionals, the pharmaceutical industry, and clinical trial investigators to address barriers to Black patients enrolling in prostate cancer clinical trials. Following the findings of this survey, PHEN is now collaborating with the Prostate Cancer Clinical Trials Consortium to facilitate face-to-face group meetings between patients and clinical trial investigators (Figure).

    Figure.The Prostate Health Education Network (PHEN)–Prostate Cancer Clinical Trials Consortium (PCCTC) initiative to increase enrollment of Black patients with prostate cancer into clinical trials.

    Figure. The Prostate Health Education Network (PHEN)–Prostate Cancer Clinical Trials Consortium (PCCTC) initiative to increase enrollment of Black patients with prostate cancer into clinical trials.

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Inclusion of Black males in prostate cancer clinical trials is important to understand how cancer biology and treatment responses differ in this underserved population and ensure generalizability of clinical trial results to Black populations. Notably, improvements in some efficacy outcomes were observed in Black males vs White males in studies in prostate cancer of abiraterone acetate plus prednisone,7 sipuleucel-T,8 and radiotherapy.9 Moreover, mutations in the androgen receptor gene, BRAF, and some DNA repair genes are observed more frequently in Black males than in White males with metastatic prostate cancer, which has implications for personalized treatment.10

The Prostate Health Education Network (PHEN) in the United States surveyed approximately 11,000 Black Americans in connection with the Daddy’s Boys stage plays, which tour the country and use the story of a widowed father dealing with his fractured relationships with his sons when faced with prostate cancer, to educate Americans about the disease. Surveys were completed by audience members during the intervals of performances to gain information regarding their perspectives on prostate cancer. Approximately 40% of survey respondents were male; of these, 60% would consider participating in a prostate cancer clinical study (preventive, genetic, surveillance, screening, and treatment studies). PHEN also developed the PHENPath tool,11 an online information resource for males with prostate cancer, based on accepted guidelines in prostate cancer. PHENPath highlights therapeutic options and clinical trials for males with different stages of prostate cancer.

Despite educational tools and awareness campaigns such as those highlighted above, too few Black males participate in prostate cancer clinical trials. PHEN used insights gained from the Daddy’s Boys audience to develop a questionnaire regarding prostate clinical trial participation by Black males in the United States and surveyed its members to help understand their perspectives and reasons for participation or nonparticipation.

Materials and Methods

Eligible Participants

Black males who were members of PHEN, were residing in the United States, and had a diagnosis of prostate cancer were eligible to complete the survey.

Survey

All PHEN members (who had consented to be contacted and participate in PHEN activities) were contacted by email on January 29, 2021, regarding the survey, which was completed online and remained open until March 29, 2022. A copy of the full survey is available in the online Supplementary Appendix 1 (https://www.urologypracticejournal.com). The survey comprised 21 questions, including questions about participants’ demographic and clinical data, participation in prostate cancer clinical trials, their experiences, their reasons for participating or not participating in trials, the characteristics of a trial that may influence their future decision to participate, and which qualities they considered important in a prostate cancer clinical research team. Survey questions were developed by the authors, who are subject matter experts, and were based on interviews with, and previous pilot surveys of, attendees at the Daddy’s Boys plays and PHEN educational programs (including males with prostate cancer and their family members).

Results

Demographic and Clinical Characteristics of Survey Respondents

Of 480 PHEN members who were contacted, 115 (24.0%) completed the survey. The most common presentation at diagnosis was localized prostate cancer (Table). Respondents were diverse in terms of geographical location (Figure 1; zip code available for 90 participants), age, level of education, employment status, and income (Table); 58 (50.4%) had a known family history of prostate cancer and more than half were cancer-free when the survey was completed. Respondents came from PHEN-focus cities or states (defined as cities or states with large Black populations, representing 90%-95% of the US Black population; Supplementary Table 1, https://www.urologypracticejournal.com). The geographical distribution of survey respondents in relation to states with a high incidence of prostate cancer is shown in Figure 1.12

Table. Demographic and Clinical Characteristics of Survey Respondentsa

No. (%)
Age at prostate cancer diagnosis, y (N = 115)
 40-50 7 (6.1)
 51-65 63 (54.8)
 >65 32 (27.8)
 No response 13 (11.3)
Time since initial prostate cancer diagnosis, y (N = 115)
 1-5 23 (20.0)
 6-10 36 (31.3)
 >10 41 (35.7)
 No response 15 (13.0)
Initial stage of prostate cancer at diagnosis (N = 115)
 Localized 81 (70.4)
 Locally advanced 11 (9.6)
 Metastatic 3 (2.6)
 Other 6 (5.2)
 No response 14 (12.2)
Family history of prostate cancer (N = 115)
 Yes 58 (50.4)
 No 30 (26.1)
 Unsure 15 (13.0)
 No response 12 (10.4)
Primary prostate cancer treatment (N = 103)b
 Surgery 54 (52.4)
 Radiation therapy 38 (36.9)
 Androgen deprivation therapy 14 (13.6)
 Active surveillance 11 (10.7)
 Chemotherapy 5 (4.9)
 Immunotherapy 5 (4.9)
 Other 17 (16.5)
Current prostate cancer status (N = 115)
 Cancer-free 67 (58.3)
 Receiving treatment 21 (18.3)
 Metastatic disease 5 (4.3)
 Other 11 (9.6)
 No response 11 (9.6)
Current age, y (N = 115)
 40-50 2 (1.7)
 51-60 9 (7.8)
 61-70 41 (35.7)
 >70 48 (41.7)
 No response 15 (13.0)
Marital status (N = 115)
 Married 80 (69.6)
 Single 16 (13.9)
 Widowed 4 (3.5)
 No response 15 (13.0)
Education level (N = 115)
 High school 12 (10.4)
 College 39 (33.9)
 Postgraduate 47 (40.9)
 No response 17 (14.8)
Employment status (N = 115)
 Employed 29 (25.2)
 Retired 66 (57.4)
 Unemployed 4 (3.5)
 No response 16 (13.9)
Annual income, US$ (N = 115)
 <50,000 25 (21.7)
 50,000 to <100,000 41 (35.7)
 ≥100,000 30 (26.1)
 No response 19 (16.5)

Percentages may not add up to 100% because of rounding.

Respondents could select more than 1 option.

Figure 1.US states where survey respondents were residing. aNumbers in brackets represent the incidence rates for prostate cancer in Black males, based on the data provided by Giaquinto et al.12

Figure 1. US states where survey respondents were residing. aNumbers in brackets represent the incidence rates for prostate cancer in Black males, based on the data provided by Giaquinto et al.12

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Participation in Prostate Cancer Clinical Trials

Twelve (10.4%) of the 115 respondents had participated in a prostate cancer clinical trial. All 12 respondents reported a satisfactory experience of the trial, and 11 completed their trial. Of the males who participated, 9 (75.0%) perceived the trial as advancing medical science and 8 (66.7%) perceived the trial as providing them with an effective treatment or diagnostic option for themselves; none cited financial benefits as a reason for participating.

Five (4.3%) of the 115 respondents had applied to participate in a prostate cancer clinical trial but were not accepted; 2 respondents stated that this was because of an existing medical condition, 2 did not know the reason, and 1 stated only that he did not meet the criteria, without providing further explanation.

Of the 89 responses to the question asking why Black males had not participated in a prostate cancer clinical trial, the most common reasons were not being asked if they would consider participating (49 responses [55.1%]) and lack of information about the risks and benefits of participating (12 responses [13.5%]; Figure 2; Supplementary Table 2, https://www.urologypracticejournal.com). Only 2 respondents (2.2%) cited history with Black patients (the Tuskegee study)13 as their reason. No respondents cited lack of trust in the healthcare system based on personal experience as a reason.

Figure 2.Reasons why survey respondents had not participated in a prostate cancer clinical trial (N = 89 responses). Of the 115 participants, 93 stated they had not participated in a prostate cancer clinical trial and 26 did not provide a response when asked why they did not participate. Reasons for not participating cited under “Other” included being currently cancer-free, novel treatments not being required for the form of prostate cancer they had, an appropriate trial not being available for the form of prostate cancer they had, not being eligible for participation in a clinical trial, a perceived lack of benefit from participating in a clinical trial, the perception that clinical trials were for patients who were not already in treatment, lack of time or interest, or other commitments (such as caring for elderly relatives). These data are available to view in tabular form in Supplementary Table 2 (https://www.urologypracticejournal.com).

Figure 2. Reasons why survey respondents had not participated in a prostate cancer clinical trial (N = 89 responses). Of the 115 participants, 93 stated they had not participated in a prostate cancer clinical trial and 26 did not provide a response when asked why they did not participate. Reasons for not participating cited under “Other” included being currently cancer-free, novel treatments not being required for the form of prostate cancer they had, an appropriate trial not being available for the form of prostate cancer they had, not being eligible for participation in a clinical trial, a perceived lack of benefit from participating in a clinical trial, the perception that clinical trials were for patients who were not already in treatment, lack of time or interest, or other commitments (such as caring for elderly relatives). These data are available to view in tabular form in Supplementary Table 2 (https://www.urologypracticejournal.com).

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Key Characteristics of Prostate Cancer Clinical Trials and Research Teams That May Influence Future Trial Participation

The key characteristics of a trial that respondents (N = 99) considered may influence their future decision to participate included whether they perceived the treatment or diagnostic option to be effective for themselves (54 responses [54.5%]), the trial’s potential to advance medical science (45 responses [45.5%]), and minimal potential for side effects (44 responses [44.4%]; Figure 3, A; Supplementary Table 3, https://www.urologypracticejournal.com). The key qualities that respondents (N = 97) considered most important in a prostate cancer clinical research team included staff who take the time to explain study procedures, risks, and benefits (87 responses [89.7%]) and being confident in the skills and knowledge of staff (55 responses [56.7%], Figure 3, B; Supplementary Table 4, https://www.urologypracticejournal.com).

Figure 3.(A) Characteristics of a prostate cancer clinical trial that Black males considered would most influence their future decision to participate (N = 99). B, Qualities that participants would consider important in a prostate cancer clinical trial research team (N = 97). aFor both questions, participants were asked to choose their top 3 answers. Qualities of a prostate cancer clinical trial research team cited under “Other” (B) included “physicians who look like me” and “the top group in their specialty.” These data are available to view in tabular form in Supplementary Tables 3 and 4 (https://www.urologypracticejournal.com).

Figure 3. (A) Characteristics of a prostate cancer clinical trial that Black males considered would most influence their future decision to participate (N = 99). B, Qualities that participants would consider important in a prostate cancer clinical trial research team (N = 97). aFor both questions, participants were asked to choose their top 3 answers. Qualities of a prostate cancer clinical trial research team cited under “Other” (B) included “physicians who look like me” and “the top group in their specialty.” These data are available to view in tabular form in Supplementary Tables 3 and 4 (https://www.urologypracticejournal.com).

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Racial diversity among trial investigators was also important to patients, and physicians being of the same racial group as the patient was cited by some respondents to the survey as an important quality of a clinical research team (Figure 3, B).

Discussion

Black males remain considerably underrepresented in prostate cancer clinical trials.4-6 The results from our survey suggest that the predominant reason for Black males not enrolling in prostate cancer clinical trials is that they are not being asked to participate.

In the ongoing Partnering Around Cancer Clinical Trials study, Black and White males with prostate cancer at 2 US cancer centers are being randomized to receive either usual care or an educational intervention aimed at increasing the number of patients who decide to enroll in a prostate cancer clinical trial.14 Consistent with our findings, an analysis of video-recorded patient–physician interactions in the Partnering Around Cancer Clinical Trial study found that more Black patients than White patients had at least 1 interaction with no mention of clinical trial participation (10/18 [56%] vs 5/25 [20%]).15 However, in contrast to our findings, suspicion of the healthcare system led to fewer Black males than White males (64% vs 82%) being definitely willing to discuss participation in a trial at baseline.16

Possible reasons why healthcare providers do not ask Black males about participation in prostate cancer clinical trials include lack of awareness of suitable trials,15 incorrect assumptions that patients will be concerned about the Tuskegee study,13 or that comorbidities will preclude participation.17 The accessibility of prostate cancer clinical trial sites to patients has been shown to vary geographically,18 which may influence a healthcare provider’s decision to discuss trial participation with the patient. Geographic variation may also affect the proportion of respondents who receive care from academic medical centers involved in trials. Unfortunately, the number of respondents to our survey who had participated in a trial was too small to test for an association between probability of participation and proximity to a trial center. Moreover, it is possible that providers working in the community are concerned about potential financial implications of a patient’s care being transferred to such an academic medical center. Furthermore, it may be difficult for healthcare providers without personal experience of cancer treatment to fully appreciate what is most important to patients, and clinical trial staff may sometimes make inaccurate assessments of patients’ health literacy. We suggest that patients with prostate cancer may not feel confident in asking about clinical trial enrollment, may not fully understand the benefits of genomic testing in meeting trial inclusion criteria, or may be reluctant to ask for a second opinion from a professional who could refer them to a trial, if they feel it could jeopardize relationships with their current healthcare providers. Patients may also be reluctant to suspend their current treatment to meet eligibility criteria for a trial, especially if they do not know enough about the risks and benefits of participating.

Although our survey found that the most important characteristics for a clinical research team were staff who took the time to appropriately explain the study and in whom they had confidence of their skills and knowledge, racial diversity among trial investigators and having a physician from the same racial group were also mentioned as important qualities for some respondents. Underrepresentation of physician investigators from racial minorities has been demonstrated for clinical trials in general in the United States and is believed to affect adversely participation by patients from racial minorities.19

Limitations

These data are representative of the group surveyed, namely Black males with prostate cancer who are members of PHEN, and should be considered within this context; nonrepresentation of Black males with prostate cancer who were not PHEN members is a factor to consider in the interpretation of our survey results. Most of the respondents (70%) had localized prostate cancer at diagnosis, which may reflect greater public awareness of the importance of screening. Many respondents were likely to already be knowledgeable about prostate cancer and the need for research into new treatments through their interactions with PHEN, so may not be fully representative of the general Black population with prostate cancer. This may explain why so few respondents cited the Tuskegee study or mistrust of the healthcare system based on their experiences as a barrier to participation. Nonetheless, it is important to recognize that when offered the opportunity to join a cancer clinical trial, participation rates have been found to be similar for Black and White patients (58% of Black patients chose to enroll in a clinical trial when offered the chance compared with 55% of White patients),20 which adds weight to the key finding from our survey that Black males are not being asked to become involved in prostate cancer clinical trials often enough.

The likelihood of a respondent’s healthcare provider asking him about clinical trial participation may depend on how many trials are recruiting for his stage of prostate cancer; as of July 20, 2022, ClinicalTrials.gov listed 303, 111, and 93 trials recruiting or enrolling by invitation in metastatic, localized, and recurrent prostatic carcinoma, respectively. Clinical trial availability at the time of our survey may also differ from that at the time a respondent was diagnosed with prostate cancer. However, our sample size was insufficient to examine potential associations between the probability of trial participation and the disease stage or year of diagnosis. Furthermore, the influence of a spouse or partner on decision making about clinical trial participation was not explored.

Future Perspectives

Rencsok et al5 proposed that prostate cancer clinical trials should enroll a minimum of 22.2% non-Hispanic Black males and a maximum of 56.3% non-Hispanic White males, based on the proportions of incident prostate cancer cases accounted for by each racial group in the United States. Our survey findings led to a collaboration with the Prostate Cancer Clinical Trials Consortium on an initiative aimed at increasing enrollment of Black patients with prostate cancer into clinical trials by enabling them to meet face to face in groups with trial investigators from participating centers (Figure 4, A and B). Patients can obtain information about trials while investigators learn about patients’ decision making regarding enrollment. The meetings are open to males of all races, as we consider participation in trials to be important for all males with prostate cancer, irrespective of race.

Figure 4.Concept (A) and overview (B) of the joint Prostate Health Education Network (PHEN)–Prostate Cancer Clinical Trials Consortium (PCCTC) initiative. Figure 4, A is copyright 2021 Prostate Health Education Network and used with permission.

Figure 4. Concept (A) and overview (B) of the joint Prostate Health Education Network (PHEN)–Prostate Cancer Clinical Trials Consortium (PCCTC) initiative. Figure 4, A is copyright 2021 Prostate Health Education Network and used with permission.

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Conclusions

Our survey of Black PHEN members with prostate cancer suggested that the principal reason for lack of participation by Black males in prostate cancer trials was having not been asked if they would like to participate. Yet, increased trial participation is crucial for future generations, with approximately 50% of respondents known to have a family history of prostate cancer. We call for stronger collaboration between patients, health professionals, the pharmaceutical industry, and clinical trial investigators. Engaging target communities in discussions about the value of clinical trial enrollment is key to creating inclusive clinical trial populations and can be accomplished through outreach strategies involving, for example, church and advocacy groups. The insights gained from this survey will help address barriers to trial participation, challenge assumptions by health professionals that Black males will not trust the healthcare system or trial investigators, support health professionals constructively in effective one-to-one interactions with their patients, and reinforce that knowledge is a key part of a patient’s armory in the fight against prostate cancer.

Acknowledgments

We thank Meredith Strickland and Baldev Vasir, PhD, from PHEN for analysis of the survey data, and Jennifer Ghith from Pfizer for her initial review of the draft manuscript and insights based on the survey results.

References

Funding/Support: The development of this manuscript was proposed by PHEN to Pfizer following presentation of the results at the European Association of Urology 2021 meeting. Dr Crawford, Mr Vinson, and Mr Farrington did not receive any payment from Pfizer. However, medical writing support for manuscript development, under the guidance of the authors, was provided by Ann Gordon, PhD, and Ajay Mirakhur, MPH, of CMC AFFINITY, a division of IPG Health Medical Communications, with funding from Pfizer. Editorial support for later drafts was provided by Neil Venn, PhD, Tina Allen, BSc, and Laura McArdle, BA, of Onyx (a division of Prime, London, UK), funded by Pfizer.

Conflict of Interest Disclosures: Dr Crawford is director of Clinical Trials and Patient Education for PHEN. He is on a Pfizer prostate cancer disparity working group, part of Pfizer Oncology Patient Centric Ecosystem (POPCE), and on the American Cancer Society National Prostate Cancer Roundtable (ACS NPCRT). Mr Vinson is CEO of the Prostate Cancer Clinical Trials Consortium. Mr Farrington is founder and president of PHEN. He currently serves as a member of the National Comprehensive Cancer Network (NCCN) Prostate Cancer Treatment Guidelines Panel and the NCCN Prostate Cancer Early Detection Guidelines Panel. He also serves as a trustee of the Dana-Farber Cancer Institute and as an advisor to a number of other healthcare organizations and programs.

Ethics Statement: This study was deemed exempt from Institutional Review Board review.

Author Contributions:

Conception and design: Crawford, Farrington.

Data analysis and interpretation: Vinson, Crawford.

Drafting the manuscript: Vinson, Crawford, Farrington.

Critical revision of the manuscript for scientific and factual content: Vinson, Crawford, Farrington.

Supervision: Vinson, Crawford, Farrington.

Other: Crawford.

Data Availability: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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