Alliance for Clinical Trials in Oncology highlights key role of clinical research in advancing men's cancer care

Every November, millions worldwide grow mustaches and join Movember, a global movement launched in 2003 to spark conversations about men's health, including prostate cancer, testicular cancer, and mental health. The initiative encourages men to challenge stigmas, prioritize their health, stay current with recommended screenings, and seek medical attention when symptoms arise.

Supporting Movember's mission, the Alliance for Clinical Trials in Oncology is highlighting the critical role of clinical research in advancing men's cancer care. Through greater awareness, early detection, and access to promising treatments, the Alliance aims to help improve outcomes for men with cancer and support their physical and mental well-being throughout survivorship.

With support from the National Cancer Institute, the Alliance develops and conducts clinical trials that move cancer research forward. Currently, eight ongoing studies are exploring ways to improve the detection and treatment of men's cancers, including prostate and testicular cancer, as well as enhance quality of life and support for patients and their loved ones after treatment. 

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. 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, MD, 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 treatment efficacy 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-BC, of Duke University School of Nursing, leads Project Reach, a phase III trial evaluating a text-based smoking cessation intervention for cancer survivors who smoke cigarettes and live 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 Movember, 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.