• Patients were nine times more likely to have little to no cancer remaining in the prostate after surgery, with a 20% reduction in the risk of developing metastasis or death
• Data selected to open the plenary presentation at ASCO 2026 and published in The New England Journal of Medicine
CHICAGO, May 31, 2026 /PR Newswire/ – Johnson & Johnson (NYSE:JNJ) today announced results from the final analysis of the Phase 3 PROTEUS study showing the investigational use of apalutamide plus hormone therapy (androgen deprivation therapy, ADT), given for six months before and after prostate cancer surgery, significantly improved key short- and long-term clinical outcomes for patients with high-risk localized or locally advanced disease. The trial met both primary endpoints. Patients treated with apalutamide plus hormone therapy were nine times more likely to have little to no cancer remaining at the time of surgery compared with hormone therapy alone (8.9 percent vs. 1.0 percent; pathologic complete response/minimal residual disease). The combination also reduced the risk of developing metastasis or death by 20 percent and extended the time before patients required subsequent therapy to more than six years. These findings will be presented in a plenary session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Oral Abstract #LBA1) and published simultaneously in The New England Journal of Medicine.1,2
The unmet need with standard treatments for patients with high-risk localized prostate cancer
Surgery to remove the prostate (radical prostatectomy) is one of the standard treatments for patients with high-risk localized or locally advanced disease, alongside radiation therapy.3,4 Yet nearly half of patients who undergo curative-intent surgery will see their cancer return, requiring additional treatment and moving beyond the point where cure is possible.5,6,7 Additional therapies are often used only after the cancer has spread, missing a critical window to intervene earlier and improve long-term outcomes.8
Apalutamide blocks androgen hormones from binding to their receptor, which can help slow prostate cancer progression. It is currently approved for use in advanced prostate cancer, including cases where the disease has spread (metastatic castration-sensitive) or is no longer responding to certain hormone therapies (non-metastatic castration-resistant prostate cancer).9
Expert perspectives on the perioperative use of ERLEADA® plus hormone therapy six months before and after prostate cancer surgery
“Reducing the risk of prostate cancer recurrence and death with improved initial treatment regimens has been a longstanding unmet need for patients with localized high-risk prostate cancer,” said Mary-Ellen Taplin,* M.D., FASCO, medical oncologist at Dana-Farber Cancer Institute and Harvard Medical School, and principal investigator. “The PROTEUS trial demonstrates that adding preoperative apalutamide to androgen deprivation therapy and surgery reduced the risk of metastases or death by 20 percent. This result is most impactful as it may reduce the need for subsequent therapies and related side effects, while also increasing potential cure rates. This approach, which combines systemic therapy with surgery, is already standard in other aggressive cancers and now has proven benefit in patients with this disease.”
“For decades, surgery has been the standard approach for many patients with high-risk localized or locally advanced prostate cancer, but these data suggest it may not be enough on its own,” said Adam Kibel,† M.D., urologic surgeon and chair of the Department of Urology at Mass General Brigham. “Earlier integration of apalutamide has the potential to reshape how prostate cancer is treated by building on curative-intent surgical treatment and improving outcomes for these patients.”
About the PROTEUS study
PROTEUS (NCT03767244) is a randomized, double-blind, placebo-controlled Phase 3 study evaluating apalutamide in combination with androgen deprivation therapy (ADT) in patients with high-risk localized or locally advanced prostate cancer who are candidates for radical prostatectomy. Approximately 2,000 patients were enrolled and randomized to receive apalutamide or placebo, each in combination with ADT, administered before and after radical prostatectomy with pelvic lymph node dissection. Patients with distant metastatic disease, as determined by conventional imaging, were excluded from the study.10
Apalutamide was administered orally at 240 mg once daily. All study participants underwent protocol-defined surgery and were followed for long-term outcomes, including recurrence and progression. The dual primary endpoints of the study are pathologic complete response (pCR) and metastasis-free survival (MFS), with pCR assessed by blinded independent central pathology review and MFS assessed by blinded independent central radiology review.10
About High-Risk Localized or Locally Advanced Prostate Cancer
Approximately 330,000 people are diagnosed with prostate cancer each year in the U.S.11 Up to 40 percent of patients will be classified as high-risk.12 Despite advancements in treatment, disease recurrence remains substantial in patients with high-risk localized or locally advanced prostate cancer; up to 50 percent of patients within five years of surgery experience recurrence and carry a significant risk of disease progression and death.5,6 It’s estimated that more than 36,000 patients will succumb to prostate cancer in 2026, which reinforces the importance of choosing the best possible therapy early for patients with advanced prostate cancer.8,12
About ERLEADA®
ERLEADA® (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). ERLEADA® received U.S. Food and Drug Administration (FDA) approval for nmCRPC in February 2018 and received U.S. FDA approval for mCSPC in September 2019. To date, more than 340,000 patients worldwide have been treated with ERLEADA®.9 Additional studies are ongoing to evaluate ERLEADA® in earlier stages of prostate cancer, including high-risk localized and locally advanced disease.
The legal manufacturer for ERLEADA® is Janssen Biotech, Inc. For more information, visit www.ERLEADAHCP.com.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
*Dr. Taplin has provided consulting, advisory, and speaking services to Johnson & Johnson; she has not been paid for any media work.
†Dr. Kibel has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.
Source: Johnson & Johnson
1 Taplin, M. et. al. Perioperative (neoadjuvant and adjuvant) apalutamide (APA) + androgen deprivation therapy (ADT) vs placebo (PBO) + ADT with radical prostatectomy (RP) in high-risk localized or locally advanced prostate cancer (HR LPC/LAPC): Final analysis of the PROTEUS phase 3 study. Presented at: 2026 American Society of Clinical Oncology (ASCO); May 31, 2026; Chicago.
2 Taplin ME, Gleave M, Shore ND, et al. Perioperative Apalutamide in High-Risk Localized Prostate Cancer. N Engl J Med. 2026. doi:10.1056/NEJMoa2603878.
3 Young HH. The early diagnosis and radical cure of carcinoma of the prostate. Being a study of 40 cases and presentation of a radical operation which was carried out in four cases. 1905. J Urol. 2002;168:914-21. doi:10.1016/s0022-5347(05)64542-9
4 Cooley LF, Shore ND. Historic progression of prostatectomy techniques and associated outcomes. Transl Androl Urol. 2025;14:493-495. doi: 10.21037/tau-2025-3
5 Eiber M, et al. PHAROS, a real-world multi-country European study on patients with high-risk localised and locally advanced prostate cancer receiving radical treatment. J Clin Oncol. 2024;42:5024. DOI: 10.1200/JCO.2024.42.16_suppl.502
6 Stattin P, et al. Population-based study of disease trajectory after radical treatment for high-risk prostate cancer. BJU Int. 2024;134:96-102. doi.org/10.1111/bju.16362
7 National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: prostate cancer. Version 5.2026. Accessed May 2026. https://www.nccn.org.
8 American Cancer Society. Initial treatment of prostate cancer, by stage and risk group. Accessed May 2026. https://www.cancer.org/cancer/types/prostate-cancer/treating/by-stage.html
9 ERLEADA® U.S. Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
10 ClinicalTrials.gov. A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy (PROTEUS). Available at: https://clinicaltrials.gov/ct2/show/NCT04077463. Accessed May 2026.
11 American Cancer Society. Key statistics for prostate cancer. Accessed May 2026. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html
12 Napodano G, Ferro M, Sanseverino R. High-risk prostate cancer: A very challenging disease in the field of uro-oncology. Diagnostics (Basel). 202126;11(3):400. doi:10.3390/diagnostics11030400