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The phase 3 ARASTEP trial will investigate Nubeqa plus androgen-deprivation therapy in certain patients with hormone-sensitive prostate cancer.
Researchers are looking to enroll approximately 750 patients in the phase 3 ARASTEP clinical trial, which will investigate Nubeqa (darolutamide) plus androgen-deprivation therapy (ADT) for the treatment of patients with high-risk, biochemical recurrence hormone-sensitive prostate cancer who have no evidence of metastatic disease, according to a press release from Bayer, the pharmaceutical company developing Nubeqa.
Of note, the press release explained that biochemical recurrence is defined as rising prostate-specific antigen (PSA) levels with a doubling time of less than 12 months, with no evidence of metastatic disease seen on conventional imaging such as PET or CT scans.
“Many patients with rising PSA levels following surgery or radiation are at an increased risk of developing metastasis. With ARASTEP, we are optimistic about the potential to help patients at this earlier stage of the disease,” Dr. Tara Frenkl, senior vice president and head of oncology development at Bayer, said in the release.
Patients involved in the trial will be randomly assigned to one of two groups; some patients will receive 600 mg Nubeqa, daily, plus ADT while others will receive a placebo (a substance with no therapeutic value) plus ADT. The main goal of the trial is to see if there is a difference in radiological progression-free survival (time from treatment until the disease spreads or worsens), as measured by a PSMA PET/CT scan between both groups 12 months after enrollment.
The study will also look at overall survival (percentage of patients who are alive) and radiographic progression-free survival at the 24-month mark, as well as time to castration-resistant prostate cancer, complete PSA response rate and number of patients who experience side effects, according to the release.
Nubeqa is an androgen receptor inhibitor, meaning that it blocks androgen hormones, which play a role in the development and spread of prostate cancer. The drug was initially approved in July 2019 for the treatment of non-metastatic castration-resistant prostate cancer after data from the ARAMIS trial showed that Nubeqa plus ADT improved metastasis-free survival (time from diagnosis or treatment until the appearance of distant metastasis) compared with placebo plus ADT.
More recently, an expert leading the ARASENS clinical trial, which evaluated the drug in combination with ADT and docetaxel, said that Nubeqa plus ADT and docetaxel, “should be considered a new standard of care for patients with metastatic hormone-sensitive prostate cancer,” at a major oncology conference.
While Nubeqa tends to be well-tolerated, there are side effects associated with the drug, such as fatigue, muscular-skeletal discomfort, urinary tract infection, hot flush and, less commonly, hypertension (high blood pressure) or cardiovascular effects.
MORE: An Expert Discusses Nubeqa Side Effects Patients Should Know About
“Nubeqa has already demonstrated efficacy and safety in (nonmetastatic castration-resistant prostate cancer) with the phase 3 ARAMIS trial, and in (metastatic hormone-sensitive prostate cancer) with the phase 3 ARASENS trial. Our goal is to ensure that as many patients as possible benefit from this therapy; therefore, we continue to assess the potential of Nubeqa in earlier disease stages,” Frenkl said.
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