GENITOURINARY CANCERS

In the phase III SPARTAN trial, the combination of androgen receptor apalutamide and androgen deprivation therapy led to an overall survival OS benefit compared with placebo/androgen deprivation therapy in patients with nonmetastatic castration-resistant prostate cancer, based on the updated findings presented at the 2019 ESMO Congress.

Christopher Sweeney, MBBS, professor of medicine, Harvard Medical School, and physician, Dana-Farber Cancer Institute, discusses the treatment-related adverse events associated with adding enzalutamide or non-steroidal anti-androgens to testosterone suppression treatment and docetaxel in patients with metastatic hormone-sensitive prostate cancer, as seen in the ENZAMET trial.<br /> &nbsp;

Prostate Cancer

Advances in molecular profiling have driven development and use of personalized medicine approaches in oncology, enabling detection of biomarkers for predicting prognosis and treatment response and determining inheritable cancer risk.

The FDA has approved a supplemental New Drug Application for apalutamide for the treatment of patients with metastatic castration-sensitive prostate cancer.

Cabazitaxel in combination with carboplatin demonstrated an improvement in progression-free survival in comparison with cabazitaxel alone in men with metastatic castration-resistant prostate cancer. Adverse events were more common with the combination regimen, but the doublet was generally well tolerated.

Kim N. Chi, MD, discusses the safety findings for the next-generation androgen receptor inhibitor apalutamide in combination with androgen deprivation therapy in patients with metastatic castration-sensitive prostate cancer, according to findings from the phase III TITAN study. This combination was compared with placebo and ADT and presented at the 2019 ASCO Annual Meeting.

Cristina Magi-Galluzzi, MD, PhD, discussed the role of pathologists in the diagnosis and treatment decision for patients with prostate, bladder, and renal cancers.&nbsp;

In an interview with&nbsp;Targeted Oncology, John Bartlett, MD, explained the standardized cancer testing project, its relevance, and how it could be used to improve the treatment of patients with pancreatic, prostate, breast cancer.&nbsp;

Men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer who had baseline prostate-specific antigen levels &le;5.27 ng/mL demonstrated a median overall survival approaching 4 years with sipuleucel-T treatment, according to findings from the large real-world PROCEED trial.

The FDA has granted a priority review to a supplemental New Drug Application for a new indication for enzalutamide as a treatment for men with metastatic hormone-sensitive prostate cancer.

In an interview with <em>Targeted Oncology</em>, Agarwal, professor of medicine at the Huntsman Cancer Institute, University of Utah, gave an overview of the TALAPRO-2 trial and discussed its potential for changing the standard of care for patients with mCRPC.

Karim Fizazi, MD, PhD, discusses the potential role for darolutamide in combination with androgen deprivation therapy in patients with nonmetastatic castration-resistant prostate cancer.

PET imaging modalities such as fluciclovine PET, choline PET, and more recently PSMA-PET are more sensitive in the detection of both soft tissue and bone metastases. These newer modalities have the potential to better identify patients who are eligible for targeted treatment of oligometastases with radiation or treatments more appropriate for immediate systemic androgen deprivation, according to Arjun V. Balar, MD.

Olaparib demonstrated a statistically significant improvement in radiographic progression-free survival compared with enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer who have a homologous recombination repair mutation and have progressed on prior treatment with new hormonal anticancer treatments, according to early findings from the PROfound trial.

Take a look back on the FDA happenings, including approvals, fast track designations, priority reviews, and more from the month of July 2019.

Darolutamide has been approved by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer.&nbsp;

Evan Y. Yu, MD, discussed the key takeaways from the phase Ib/II KEYNOTE-365 trial, which evaluated different novel pembrolizumab (Keytruda) combinations in patients with metastatic castration-resistant prostate cancer.

Testosterone suppression with docetaxel, the standard of care for patients with metastatic hormone-sensitive prostate cancer (mHSPC), was combined with chemotherapy or enzalutamide (Xtandi) to assess the potential improvement in overall survival compared with non-steroidal anti-androgens like bicalutamide, nilutamide, and flutamide in the&nbsp;phase III ENZAMET trial.&nbsp;<br /> &nbsp;