September is Prostate Cancer Awareness Month, and the Alliance for Clinical Trials in Oncology is highlighting the importance of clinical research in advancing better treatments and improving early detection to ultimately help prevent and cure prostate cancer.
On average, men in the United States have about a 1 in 8 chance of developing prostate cancer during their lifetime, according to the National Cancer Institute. In 2026, an estimated 331,000 men will be diagnosed with prostate cancer and about 36,000 will die from the disease.
About 60% of prostate cancers are diagnosed in men aged 65 and older. Men of African or Caribbean descent, tobacco smokers and those with a family history of prostate cancer are at higher risk of developing the disease. Although prostate cancer often has no symptoms, men who have trouble urinating, have painful urination, or find blood in their urine should talk to their doctor.
Although the risk of developing prostate cancer over a man’s lifetime is high, there is reason for hope. Thanks to advances in early detection, treatment and survivorship, the mortality rate from prostate cancer has declined by about half since 1993, reports the American Cancer Society.
That progress did not happen by chance. Clinical trials helped provide the evidence needed to discover new treatments, determine which therapies work best, improve screening and early detection, and find ways to help patients live longer and better after surviving their cancer.
The progress made over the past several decades has been made possible by the patients who participate in clinical trials, as well as the clinicians, researchers, advocates, and communities who make this research possible.
Today, the Alliance continues that research through clinical trials focused on treating prostate cancer, improving survivorship, advancing early detection, and reducing cancer risk.
Trials for People with Prostate Cancer
Alliance A031702 : A Phase II study of ipilimumab, cabozantinib, and nivolumab in rare genitourinary cancers (ICONIC)
Led by Andrea Apolo, MD, of the National Cancer Institute, this phase II trial is evaluating a combination of three anti-cancer drugs to treat rare genitourinary cancers that have spread, including primary small cell carcinoma of the prostate. Researchers are studying if combining a targeted daily pill, cabozantinib, with two intravenous immunotherapies, nivolumab and ipilimumab, can effectively shrink tumors in patients with rare cancers that often lack standardized treatment options. By pairing cabozantinib’s ability to block tumor growth enzymes and blood vessel development with checkpoint inhibitors that use the patient’s immune system to attack cancer cells, researchers aim to overcome treatment resistance in these unusual cancers.
Alliance A032102 : PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)
This phase II trial led by Rana McKay, MD, of the University of California San Diego evaluates whether using genetic profiling to match patients with metastatic prostate cancer to targeted therapies can improve treatment outcomes compared to standard treatment approaches. Participants first undergo DNA and RNA sequencing of their tumor tissue or blood sample. A molecular tumor board then evaluates the results and assigns participants into a personalized treatment arm designed to attack their cancer’s specific genetic mutations. In Arm A, participants receive valemetostat tosylate, an oral medication that inhibits EZH1 and EZH2 proteins to alter tumor gene expression and slow growth. In Arm B, participants receive intravenous carboplatin paired with cabazitaxel aimed at tumors with specific gene mutations, such as TP53, RB1, or PTEN alterations. In Arm C, participants receive one of several standard treatment options such as targeted radiopharmaceutical therapy, chemotherapy, or novel anti-androgen therapy, such as abiraterone or enzalutamide.
Alliance A032302 : Docetaxel addition in metastatic castrate-sensitive prostate cancer (ASPIRE)
Led by Deepak Kilari, MD, of Froedtert and the Medical College of Wisconsin, this phase III trial is investigating whether adding chemotherapy to current standard treatments can extend survival for men living with advanced prostate cancer. The study seeks to determine if the addition of docetaxel, an established chemotherapy drug, to hormone therapy and apalutamide (a next-generation androgen receptor inhibitor) can improve overall survival in men with newly diagnosed advanced prostate cancer. The trial’s primary endpoint is overall survival, but researchers are also conducting genetic analyses to see if patients with mutations in TP53, PTEN or RB1—genes associated with more aggressive disease—derive greater benefit from the intensified treatment.
Alliance A032304 : Radioligand efficacy comparison by initial PSA-response outcome in metastatic CRPC with Lutetium 177 Lu PSMA RLT (RECIPROCAL)
Led by Thomas Hope, MD, of the University of California San Francisco, and Deaglan McHugh, of Memorial Sloan Kettering Cancer Center, this phase III study explores whether doctors can optimize the timing of targeted radiation therapy to minimize side effects while preserving efficacy in men with advanced prostate cancer. The current standard of care for men with metastatic castration-resistant prostate cancer includes Lutetium-177 Prostate Specific Membrane Antigen (PSMA) targeted Radioligand Therapy (RLT), a targeted radiation therapy attached to a drug molecule and injected into the bloodstream. While PSMA RLT improves survival, it can cause side effects, such as dry mouth, fatigue and gastrointestinal issues. In this trial, researchers want to see if treatment after the first two doses of lutetium 177 Lu PSMA RLT can be delayed until there is evidence of disease activity. This may be an effective way to improve quality of life without decreasing lifespan in patients with advanced prostate cancer.
Alliance A222302 : Distance-based exercise to preserve function and prevent disability (DEFEND)
Kathryn Schmitz, PhD, MPH, of UPMC Hillman Cancer Center and Jennifer Ligibel, MD, of Dana-Farber Cancer Institute lead the DEFEND study that is exploring whether a structured exercise program delivered entirely through telehealth can help patients receiving chemotherapy maintain physical function, reduce fatigue, and prevent disability. The trial reflects an important part of cancer care beyond treating the tumor—helping patients remain active and maintain quality of life during treatment.
Research for Prostate Cancer Survivors
Alliance A211901 : Reaching rural cancer survivors who smoke using text-based cessation interventions
Devon Noonan, PhD, MPH, FNP-B, of Duke University School of Nursing, leads Project Reach, a Phase III trial evaluating a text-based smoking cessation intervention for cancer survivors living in rural communities. Because smoking can affect cancer outcomes and overall health, the trial aims to identify accessible ways to help cancer survivors stop smoking.
Research Focused on Prevention and Early Detection
Alliance A212102 : Blinded reference set for multicancer early detection blood tests
Marie Wood, MD, of the University of Colorado School of Medicine, leads this study to collect and store blood and tissue samples from people with and without cancer to help evaluate and advance tests designed to detect multiple cancers earlier. Prostate cancer is among the cancers represented in this research.
Alliance A232301CD : An enhanced eHealth and chatbot-enabled delivery model for clinical genetic services in community AYA cancer patients
Angela Bradbury, MD, of the University of Pennsylvania Abramson Cancer Center leads the AYA Access Study exploring whether online genetic education and at-home genetic testing can make genetic risk information more accessible to adolescents and young adults (AYA) with a history of cancer. The study addresses barriers that can prevent young adults from accessing genetic services.
Continuing Progress
During Prostate Cancer Awareness Month, the Alliance recognizes the patients and survivors who participate in clinical trials, the families and advocates who support them, and the clinicians and researchers who dedicate their expertise to advancing cancer care.
Every clinical trial adds to what we know. Every participant helps move science forward. And every discovery brings us closer to a future where fewer people are diagnosed with prostate cancer and more people survive it.
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The Alliance for Clinical Trials in Oncology is a national leader in advancing cancer research, uniting more than 26,000 cancer specialists at 112 main institutions and 1,400 affiliates across the U.S. and Canada. As part of the National Clinical Trials Network and a leading research base for the NCI Community Oncology Research Program, the Alliance conducts pioneering, practice-changing clinical trials that improve outcomes and reshape standards of care. Our work has led to multiple FDA approvals, influenced national guidelines, and produced hundreds of high-impact publications. More than 40,000 participants have taken part in Alliance studies, and our growing biospecimen repository now includes more than 1.5 million samples, collected over the past 30 years. Learn more at allianceforclinicaltrialsinoncology.org.