Quoc-Dien Trinh, MD, MBA, is chair of the Department of Urology at the University of Pittsburgh School of Medicine and UPMC.

Quoc-Dien Trinh, MD, MBA, is chair of the Department of Urology at the University of Pittsburgh School of Medicine

The implications of these findings is that we need to strongly consider treatment intensification in all populations based on these data and specifically in the Black population."

Quoc-Dien Trinh, MD, MBA, chair of the Department of Urology at the University of Pittsburgh School of Medicine and UPMC, discussed the clinical implications of outcomes for Black patients with metastatic hormone-sensitive prostate cancer (mHSPC) treated with darolutamide (Nubequa) plus androgen deprivation therapy (ADT) in the phase 3 ARANOTE trial (NCT04736199).

Darolutamide is a second-generation androgen receptor inhibitor designed to bind directly to the androgen receptor. Prior findings from ARANOTE supported the submission of a supplemental new drug application to the FDA seeking the approval of darolutamide in combination with ADT for the treatment of patients with mHSPC.

According to Trinh, the subgroup analysis of Black patients treated during the ARANOTE trial demonstrated that darolutamide plus ADT (n = 41) reduced the risk of radiographic progression or death by 49% compared with placebo plus ADT (n = 24; HR, 0.51; 95% CI, 0.21-1.23). Median radiographic progression-free survival (rPFS) was not reached in either treatment arm, and the rPFS benefit appeared consistent across prespecified clinical subgroups, despite small sample sizes. Trinh emphasized that these findings strongly support the need for treatment intensification strategies across all patient populations, including Black patients, who have historically been underrepresented in clinical research.

Additional efficacy measures showed that patients receiving darolutamide plus ADT achieved higher rates of prostate-specific antigen (PSA) responses (<0.2 ng/mL) and delayed time to PSA progression compared with those receiving placebo plus ADT. The safety profile of darolutamide was favorable and consistent with the overall ARANOTE population, with no new safety concerns observed.

Trinh highlighted that patients, particularly from underserved populations, should be encouraged to advocate for evidence-based treatment options. He stressed that clinicians must integrate emerging data that specifically evaluate outcomes in diverse populations into routine decision-making processes to ensure equitable care.

Potential future directions include continued efforts to validate darolutamide’s benefits in real-world settings and to design prospective trials that specifically enrich for diverse patient populations, Trinh concluded.

Videos

Quoc-Dien Trinh, MD, MBA, discusses outcomes for darolutamide plus ADT in Black patients with metastatic hormone-sensitive prostate cancer. 

Dr Trinh on Outcomes for Darolutamide Plus ADT in Black Patients With mHSPC

Quoc-Dien Trinh, MD, associate professor of surgery, Harvard Medical School, and co-director, Dana-Farber/Brigham and Women's Prostate Cancer Center, discusses findings from a study examining the temporal changes in cancer tests and diagnoses in a large healthcare system in the United States during the COVID-19 pandemic. 

When examining the recovery of cancer screening tests following the first peak of the pandemic, it is not surprising that recovery did not occur equally across all disease states, as some tests are more complex than others, according to Trinh. For example, the logistics of a colonoscopy are more complicated than that of a prostate-specific antigen test, Trinh notes. For the latter, a patient can visit an affiliated center to receive a blood test; the former requires visiting the hospital to undergo an exam.

Documenting and quantifying the challenges faced to perform and recover these screening tests will help institutions understand the resources needed to address them, Trinh concludes.

Quoc-Dien Trinh, MD, discusses findings from a study examining the temporal changes in cancer tests and diagnoses in a large healthcare system in the United States during the COVID-19 pandemic. 

Dr. Trinh on the Recovery of Cancer Screening Tests Following First COVID-19 Pandemic Peak

Quoc-Dien Trinh, MD, an associate professor of surgery at Harvard Medical School; co-director of the Dana-Farber/Brigham and Women's Prostate Cancer Center; and director of the Ambulatory Clinical Operations in the Division of Urological Surgery at Brigham and Women’s Hospital, discusses the challenges of re-establishing standard surgical procedures in patients with prostate cancer following the initial wave of the 

In March 2020, many patients with indolent cancers had their surgeries safely postponed due to the COVID-19 pandemic, Trinh explains. In general, patients were understanding of this, and accepted that postponing surgery could minimize their risk of contracting or spreading the virus. 

Now, surgeries are beginning to pick back up, particularly with regard to high-priority procedures, Trinh says. 

However, according to Trinh, patients are more reluctant to undergo surgery as they do not feel ready to return to the hospital.

As such, it is important to re-establish patients’ trust and inform them of any measures that have been implemented to ensure their safety in the operating room, Trinh concludes. 

Quoc-Dien Trinh, MD, discusses the challenges of re-establishing standard surgical procedures in patients with prostate cancer following the initial wave of the coronavirus disease 2019 pandemic. 



Dr. Trinh on Re-Establishing Standard Surgical Procedures in Prostate Cancer 

Quoc-Dien Trinh, MD, an associate professor of surgery at Harvard Medical School; co-director of the Dana-Farber/Brigham and Women's Prostate Cancer Center; and director of the Ambulatory Clinical Operations in the Division of Urological Surgery at Brigham and Women’s Hospital, discusses the impact of the coronavirus disease 2019 (COVID-19) pandemic on prostate cancer.

Historically, prostate cancer has been a complex disease, says Trinh​. Moreover, the COVID-19 pandemic has amplified this complexity.

Among patients who are scheduled to undergo surgery, it is necessary to weigh the risks and benefits of the intervention before any final decisions are made, ​Trinh explains.

For example, high-risk patients ​could be offer​ed alternative treatment, such as neoadjuvant androgen deprivation therapy, Trinh concludes.

Quoc-Dien Trinh, MD, discusses the impact of the coronavirus disease 2019  pandemic on prostate cancer.

Dr. Trinh on the Impact of the COVID-19 Pandemic on Prostate Cancer

Quoc-Dien Trinh, MD, an associate professor of surgery at Harvard Medical School; co-director of the Dana-Farber/Brigham and Women's Prostate Cancer Center; and director the of Ambulatory Clinical Operations in the Division of Urological Surgery at Brigham and Women’s Hospital, discusses current strategies on postponing treatment for patients with high-risk prostate cancer during the COVID-19 crisis.

A lot of literature and some internal or external guidance have been published regarding the postponement of surgery in prostate cancer, says Trinh. However, no clear guidelines inform on how to manage 1 patient versus another. The National Comprehensive Cancer Network guidelines said that patients with low- or intermediate-risk prostate cancers can have their surgeries postponed; however, high-risk patients should receive treatment sooner. Regardless, the recommendations should not be considered clear guidance supported by level 1 evidence, Trinh cautions.

Internally, at the Brigham and Women’s Hospital and Dana-Farber, guidance was crafted to help manage patients with prostate cancer while achieving some consistency among providers. Most physicians could agree that the majority of low- and intermediate-risk patients with prostate cancer can be safely postponed by 4 weeks, 8 weeks, or 12 weeks; that is what was done with the majority of cases at these institutions.

The trickier question is determining what to do for high-risk patients. In some instances, treatment can be immediately administrated as it would normally, despite the risk of COVID-19. However, this should only happen after patients are carefully counseled about the benefits and risks of doing so, says Trinh. 

Alternative plans include giving patients neoadjuvant androgen deprivation therapy, either as part of a clinical trial, such as PROTEUS, or off trial. This will minimize the potential for disease spread, while holding off on treatment because of the crisis has been considered, concludes Trinh.

Quoc-Dien Trinh, MD, discusses current strategies on the treatment of patients with high-risk prostate cancer during the COVID-19 crisis.


Dr. Trinh on Prostate Cancer Treatment During the COVID-19 Crisis

Quoc-Dien Trinh, MD, an associate professor of surgery at Harvard Medical School, co-director of the Dana-Farber/Brigham and Women's Prostate Cancer Center, and director the of Ambulatory Clinical Operations in the Division of Urological Surgery at Brigham and Women’s Hospital, discusses ​the challenges of the novel coronavirus disease 2019 (COVID-19) pandemic in prostate cancer. 

​Prior to COVID-19, prostate cancer was a challenging and complex disease, says Trinh. As such, these challenges have been amplified amid the ongoing pandemic. 

For example, visitor restrictions in the hospital have left many patients to go through their treatment alone, Trinh explains. Moreover, patients are being forced to make treatment-related decisions without additional support from their loved ones. 

Notably, the uptake of telemedicine has played a role in mitigating this challenge as patients are able to consultations at home and other family members are able to join in on the video conference, says Trinh.

​Despite this, telemedicine has created a novel challenge in the treatment of patients with prostate cancer as physical examination remains a deciding factor in whether a patient requires surgery, Trinh concludes.

Quoc-Dien Trinh, MD, discusses ​the challenges of the novel coronavirus disease 2019 pandemic in prostate cancer. 

Dr. Trinh on the Challenges of the COVID-19 Pandemic in Prostate Cancer    

Quoc-Dien Trinh, MD, an associate professor of surgery at Harvard Medical School, co-director of the Dana-Farber/Brigham and Women's Prostate Cancer Center, and director the of Ambulatory Clinical Operations in the Division of Urological Surgery at Brigham and Women’s Hospital, discusses surgical considerations for patients with in prostate cancer in light of the novel coronavirus disease (COVID-19) pandemic.

In March 2020, it was decided that elective procedures needed to be postponed, says Trinh. However, the big questions that are: What constitutes an elective surgery? Also, which cancer surgeries can be safely postponed?

In the field of prostate cancer, there was some consensus that most cases could be safely postponed by a couple of weeks. There is no controversy for low-risk patients with prostate cancer who would have been safely put on active surveillance either way, says Trinh. If for some reason it was decided that a low-risk patient should be operated on, a postponement of 1 month, 2 months, or 3 months, would not make much difference, according to Trinh. For most intermediate-risk patients with prostate cancer, postponement is also not associated with worse outcomes based on some retrospective data from different sources that have been published throughout the years. The big question is focused on what should be done for those with high-risk prostate cancer.

In some instances, some have advocated for surgery despite the potential risk. In other instances, these procedures were postponed. At Dana-Farber Cancer Institute, there has been some consideration for putting these patients on neoadjuvant androgen deprivation therapy (ADT) for several months before proceeding with surgery; this can be done either as part of a clinical trial, such as PROTEUS, or even off trial, concludes Trinh.

Quoc-Dien Trinh, MD, discusses surgical considerations for patients with prostate cancer in light of the novel coronavirus disease pandemic.

Quoc-Dien Trinh, MD

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