Ray McDermott, MB, BCh, BAO, PhD, MBA, FRCPI, a clinical professor of medical oncology at the University College Dublin, discusses preventing recurrence in patients with very high-risk prostate cancer.

Patients with very high-risk prostate cancer tend to have increased prostate-specific antigen after having undergone a radical proctectomy, says McDermott. Investigators should be looking at different treatments and methods in order to prevent recurrence. One way this can be achieved, McDermott recommends, is by identifying centers where the DASL-HiCAP trial is open and see if the patients are eligible to be treated with darolutamide (Nubeqa) plus androgen deprivation therapy and definitive or salvage radiation.

However, for patients with metastatic castration-resistant prostate cancer who harbor 

 mutations, there is a survival advantage with PARP inhibitors in the pivotal phase 3 PROfound study are exciting and great for patients, explains McDermott. The study included a smaller patient population, but results show that patients need to be tested to determine whether they have targetable mutations. As a result, patients are living longer and can avoid more toxic treatments, such as chemotherapy, concludes McDermott.

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Ray McDermott, discusses preventing recurrence in patients with very high-risk prostate cancer.

Dr. McDermott on Preventing Recurrence of High-Risk Prostate Cancer

Ray McDermott, MB, BCh, BAO, PhD, MBA, FRCPI, a clinical professor in Medical Oncology at the University College Dublin, discusses the design of the DASL-HiCAP trial in high-risk prostate cancer.

The ongoing phase 3 study is evaluating the addition of darolutamide (Nubeqa) to androgen deprivation therapy and definitive or salvage radiation in men with high-risk prostate cancer.

Participants will be randomized 1:1 to receive darolutamide for 96 weeks or placebo, McDermott says.

Patients will be stratified by factors such as pelvic nodal status, prior exposure to docetaxel, and prior prostatectomy, says McDermott.

The trial, which was initially designed in Australia, will enroll 1100 patients from the United States, Europe, Canada, Australia, and New Zealand, concludes McDermott.

Ray McDermott, MB, BCh, BAO, PhD, MBA, FRCPI, discusses the design of the DASL-HiCAP trial in high-risk prostate cancer.

Dr. McDermott on the Design of the DASL-HiCAP Trial in High-Risk Prostate Cancer 

Ray McDermott, MB, BCh, BAO, PhD, MBA, FRCPI, a clinical professor in Medical Oncology at the University College Dublin, discusses the next steps of the phase 3 DASL-HiCAP trial in high-risk prostate cancer.

The ongoing DASL-HiCAP trial is testing the addition of darolutamide (Nubeqa) to androgen deprivation therapy (ADT) and definitive or salvage radiation in men with high-risk prostate cancer. 

Although the trial is currently recruiting patients, the coronavirus disease 2019 pandemic will likely delay the full accrual process, McDermott says.

Additionally, accrual needs to commence in multiple different centers worldwide, explains McDermott. Should these sites open within 2020, the accrual process will commence for a period of about 2 years. 

As men with prostate cancer can recur years into remission, follow-up will likely take several years to determine whether the primary end point of the trial was met, McDermott concludes.

Ray McDermott, MB, BCh, BAO, PhD, MBA, FRCPI, discusses the next steps of the phase 3 DASL-HiCAP trial in high-risk prostate cancer.










Dr. McDermott on the Next Steps of the DASL-HiCAP Trial in High-Risk Prostate Cancer 

Ray McDermott, MB, BCh, BAO, PhD, MBA, FRCPI, a clinical professor in Medical Oncology at the University College Dublin, discusses the rationale for the addition of darolutamide (Nubeqa) to androgen deprivation therapy (ADT) and definitive or salvage radiation in very high-risk prostate cancer.

Two patient populations are under examination in the phase 3 DASL-HiCaP study, says McDermott. The first patient population include those who are receiving definitive treatment with radiation and ADT for very high-risk prostate cancer. The second patient population is comprised of those who have already undergone a radical proctectomy and who have a prostate-specific antigen that isn't 0, adds McDermott; these patients are eligible for salvage radiotherapy with hormones. In both of those cases it is known that with the current standard of care, despite everything that is done for these patients, a significant proportion will develop metastatic disease over the next 5 years, according to McDermott.

The rationale for the DASL-HiCaP study is to look at the addition of darolutamide, which is a novel androgen receptor blocker, to see whether the incidence of metastases developing over time can be reduced in patients with very high-risk prostate cancer, concludes McDermott.

Ray McDermott, MB, BCh, BAO, PhD, MBA, FRCPI, discusses the rationale for the addition of darolutamide to androgen deprivation therapy and definitive or salvage radiation in very high-risk prostate cancer.

Ray McDermott, MB, BCh, BAO, PhD, MBA, FRCPI

Articles

Dr. McDermott on Preventing Recurrence of High-Risk Prostate Cancer

Dr. McDermott on the Design of the DASL-HiCAP Trial in High-Risk Prostate Cancer

Dr. McDermott on the Next Steps of the DASL-HiCAP Trial in High-Risk Prostate Cancer

Dr. McDermott on Rationale for Darolutamide Plus ADT/Radiation in High-Risk Prostate Cancer