Boston, MA (September 9, 2022) – The Alliance Foundation Trials, LLC (AFT) will present data from PRESTO (AFT-19), the first trial to assess whether scaling up treatment beyond androgen deprivation therapy (ADT) by adding apalutamide with or without abiraterone acetate plus prednisone for a limited duration will prolong disease progression in patients with biochemically relapsed high-risk prostate cancer. For men whose prostate-specific antigen (or PSA) rises, a common treatment approach is to use hormone therapy (also called ADT) to control the spread of cancer. Although ADT is initially effective in lowering PSA, men often relapse and eventually the cancer becomes resistant to ADT. The trial showed that combined hormone therapy, given over a finite 12-month treatment interval, suppresses PSA levels more sustainably compared to hormone injections alone, without affecting testosterone recovery after treatment ends .
The principal investigator of the trial Rahul Aggarwal, MD (UCSF Helen Diller Family Comprehensive Cancer Center), will present late-breaking data (LBA63) from AFT-19 during a paper presentation on Sunday, September 11 at the 2022 Congress of the European Society for Medical Oncology (ESMO ) in Paris, France.
“Patients whose PSA rises rapidly after previous surgery to treat their prostate cancer are at high risk of developing distant metastases,” Dr Aggarwal said in the photo. “Hormone therapy to suppress testosterone levels is a common way to treat this disease, but treatment can be associated with side effects. So we often give hormone therapy for a fixed time interval and then stop as part of an intermittent treatment approach.
PRESTO is a randomized phase III trial that enrolled 504 patients with high-risk prostate cancer in biochemical relapse. The control group was ADT alone with treatment intensified by adding apalutamide or apalutamide and abiraterone acetate plus prednisone for up to 52 weeks. The primary PSA progression-free survival endpoint for apalutamide and apalutamide with abiraterone acetate plus prednisone showed significant improvement over ADT alone (median 24.9 months versus 20. 3 months, hazard ratio = 0.52, one-sided p-value = 0.00047 and median of 26.0 months vs 20.0 months, hazard ratio = 0.48, one-sided p-value = 0.00008, respectively) . Recovery of testosterone was similar across all three treatment arms. Grade 2 or higher adverse events were similar between arms except for higher hypertension in arm C with the addition of abiraterone acetate plus prednisone.
These results showed that more complete androgen receptor blockade with apalutamide or apalutamide and abiraterone acetate plus prednisone prolonged disease progression with a manageable side effect profile in these patients. of biochemically recurrent high-risk prostate cancer compared to ADT alone.
“Longer follow-up is needed to assess the impact of treatment on the risk of developing distant metastases,” Dr. Aggarwal concluded.
PRESTO was a collaboration between Alliance Foundation Trials and Janssen Pharmaceuticals.
“This trial has been a great example of how industry and academia can come together to move the needle in prostate cancer care,” said the chair of the genitourinary committee. Alliance. Michael J. Morris, MD, medical oncologist and chief of the prostate cancer section at Memorial Sloan Kettering Cancer Center, pictured. “The trial was designed and executed jointly, and would not have been possible without the expertise and resources of both parties.”
ClinicalTrials.gov ID: NCT03009981
IND Sponsor: Alliance Foundation Trials, LLC
Funding source: Janssen Scientific Affairs, LLC
About Alliance Foundation Trials, LLC
Alliance Foundation Trials, LLC is a research organization that develops and conducts clinical trials in cancer, in close collaboration with scientific researchers and the network of institutional members of the Alliance for Clinical Trials in Oncology, research collaborators and non-NCI funding sources. AFT seeks to realize the vision of the Alliance for Clinical Trials in Oncology to reduce the impact of cancer on people by uniting a broad community of scientists and clinicians from many disciplines committed to discovering, validating and disseminating strategies effective in the prevention and treatment of cancer. Current AFT studies are funded by a number of pharmaceutical company collaborators and the Patient-Centered Outcomes Research Institute (PCORI). For more information on AFT studies, visit www.AllianceFoundationTrials.org.
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