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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.
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)
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
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).
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).
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.
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.
2. . Secondary prostate cancer screening outcomes by race in the Prostate, Lung, Colorectal,
and Ovarian (PLCO) screening trial. Prostate. 2018; 78(11):830-838. doi: 10.1002/pros.23540Crossref, Medline, Google Scholar
4. . PD28-01 Racial/ethnic diversity in urologic oncologic clinical trials as compared
to the National Cancer Database. J Urol. 2021; 206(Suppl 3):e520. doi: 10.1097/ju.0000000000002029.01Link, Google Scholar
7. . A prospective trial of abiraterone acetate plus prednisone in Black and White men
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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.
This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited.
The work cannot be changed in any way or used commercially without permission from
the journal.
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.
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.