Johnson & Johnson’s Phase 3 prostate cancer study shows ERLEADA® (apalutamide) before and after surgery significantly reduces risk of metastasis or death, versus hormone therapy alone, potentially shifting a decades-long treatment paradigm
Compared with patients receiving hormone therapy alone, patients were nine times more likely to have little to no cancer remaining in the prostate after surgery, with a 20 percent reduction in the risk of developing metastasis or death1
Data selected to open the plenary presentation at ASCO 2026 and published in The New England Journal of Medicine1,2
BEERSE, BELGIUM, May 31, 2026 (GLOBE NEWSWIRE) — Johnson & Johnson today announced results from the final analysis of the Phase 3 PROTEUS study showing the investigational use of ERLEADA® (apalutamide) plus hormone therapy (androgen deprivation therapy), given for six months before and after prostate cancer surgery, significantly improved key short-and long-term clinical outcomes, versus placebo plus hormone therapy, for patients with high-risk localised or locally advanced disease.1 The trial met both primary endpoints.1 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).1 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.1 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 localised prostate cancer
Surgery to remove the prostate (radical prostatectomy) is one of the standard treatments for patients with high-risk localised 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 Additional therapies are often used only after the cancer has spread, missing a critical window to intervene earlier and improve long-term outcomes.7
Expert perspectives on the perioperative use of apalutamide plus hormone therapy six months before and after prostate cancer surgery
“For many patients with high-risk localised prostate cancer, surgery alone may not be enough to prevent recurrence and disease progression, and many will ultimately go on to develop more advanced disease,” said Alberto Briganti, M.D., Professor of Urology and Urologic Surgeon at IRCCS San Raffaele Hospital, Milan.* “The PROTEUS findings signal the potential for a practice-changing shift, supporting a perioperative treatment approach that integrates apalutamide alongside curative-intent surgical treatment, with the potential to improve long-term outcomes and redefine how we manage patients with aggressive localised disease.”
“The PROTEUS study data reflect Johnson & Johnson’s long-standing commitment to transforming outcomes for patients across the prostate cancer journey. Our ambition is to continue advancing therapies into earlier lines of treatment, where intervention may have the greatest potential to alter the course of disease,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson. “By building on the established role of surgery with innovative systemic approaches, like apalutamide plus hormone therapy, we are helping drive a more proactive treatment strategy, tailored to patients’ evolving needs and ultimately aimed at delivering more durable outcomes.”
“These findings point to a new potential way of treating patients with high-risk localised or locally advanced prostate cancer,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “We are now seeing the impact of apalutamide when used earlier, alongside surgery. As the first therapy in its class to show benefit in this setting, these data reinforce apalutamide’s differentiated profile and the need to move beyond a surgery‑only approach to treating earlier and improving long‑term outcomes.”
Detailed PROTEUS study results
PROTEUS is a Phase 3 study evaluating apalutamide, an androgen receptor pathway inhibitor, combined with hormone therapy before and after surgery in patients with newly diagnosed high-risk localised or locally advanced prostate cancer (n=2109).1 The dual primary endpoints were the amount of cancer remaining at surgery (pathologic complete response/minimal residual disease, pCR/MRD) and how long patients lived without the cancer spreading (metastasis-free survival, MFS), both assessed by blinded independent central review.1
At a median follow-up of 61.7 months, apalutamide plus hormone therapy met both primary endpoints. The rate of pCR/MRD was 8.9 percent with apalutamide plus hormone therapy versus 1.0 percent with hormone therapy alone (odds ratio [OR], 10.17; 95 percent confidence interval [CI], 5.27-19.64; p<0.0001).1 Apalutamide plus hormone therapy also demonstrated a statistically significant 20 percent reduction in the risk of metastasis or death (hazard ratio [HR], 0.80; 95 percent CI, 0.67-0.96; p=0.02), with five-year rates of 78.2 percent versus 73.5 percent, respectively.1,2 Similar MFS results were observed in investigator assessments (HR, 0.74; 95 percent CI, 0.62-0.87; p=0.0004).1
Key secondary endpoints also showed statistically significant and clinically relevant improvement, reinforcing the benefit of the combination across multiple measures of disease control.1 Notably, patients receiving one year of apalutamide plus hormone therapy before and after surgery went more than six years before needing subsequent therapy, compared to approximately three and a half years with hormone therapy alone (74.2 vs. 41.5 months; HR, 0.65; 95 percent CI, 0.57-0.73; p<0.0001).1 Most patients also recovered adequate testosterone levels within 8.1 months.1 Additional benefits included a 29 percent reduction in the risk of disease recurrence or death (event-free survival; HR, 0.71; 95 percent CI, 0.63-0.80; p<0.0001) and improvements in time to distant metastasis (HR, 0.68; 95 percent CI, 0.55-0.83; p=0.0002).1 Improvements were also seen in MRD as assessed by residual cancer burden rates (30.6 percent vs. 11.7 percent; OR, 3.36; 95 percent CI, 2.67-4.23; nominal p<0.0001), further supporting the depth of response.1
The safety profile of apalutamide plus hormone therapy was consistent with previous studies. The most common adverse events (AEs) among patients receiving apalutamide included hot flush (63.4 percent), urinary incontinence (50.2 percent) and erectile dysfunction (41.6 percent).1,2 Grade 3 or 4 AEs occurred in 39.6 percent of patients treated with apalutamide plus hormone therapy, compared to 31.0 percent of those receiving hormone therapy alone.1,2 Discontinuations due to AEs occurred in 7.4 percent and 2.7 percent of patients, respectively.1,2 AEs of special interest were generally comparable between treatment arms, with a higher incidence of skin rash observed with apalutamide.1,2 Rates of deaths were similar between treatment arms.1,2 In the apalutamide arm, deaths were more often unrelated to prostate cancer, while in the placebo arm, deaths were more frequently associated with disease progression or metastasis.1,2
Ongoing study of apalutamide in this setting
Apalutamide is currently approved for use in advanced prostate cancer, including cases where the disease has spread (metastatic hormone-sensitive) or is no longer responding to certain hormone therapies (non-metastatic castration-resistant prostate cancer).8
Apalutamide plus hormone therapy has not yet been approved by regulatory authorities in this setting. Additional analyses from the PROTEUS study, including ongoing evaluations against current standards of care such as surgery alone, are underway to further contextualise these findings and inform future treatment approaches.
About the PROTEUS Study
PROTEUS (NCT03767244) is a randomised, double-blind, placebo-controlled Phase 3 study evaluating apalutamide in combination with androgen deprivation therapy (ADT) in patients with high-risk localised or locally advanced prostate cancer who are candidates for radical prostatectomy.1,9 Approximately 2,000 patients were enrolled and randomised to receive apalutamide or placebo, each in combination with ADT, administered before and after radical prostatectomy with pelvic lymph node dissection.1,9 Patients with distant metastatic disease, as determined by conventional imaging, were excluded from the study.1,9
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.1,9 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.1,9
About High-Risk Localised or Locally Advanced Prostate Cancer
Approximately 473,000 men were diagnosed with prostate cancer across Europe in 2022, making it the most commonly diagnosed cancer among European men.10 An estimated 15 percent of patients present with high-risk disease at diagnosis.11,12 Patients with high-risk localised or locally advanced prostate cancer remain at substantial risk of biochemical recurrence following radical prostatectomy, with reports of biochemical progression rates exceeding 50 percent at 5 years.12
About Apalutamide
Apalutamide is an orally administered, selective androgen receptor (AR) inhibitor. The European Commission (EC) has previously approved apalutamide in the following indications in Europe:8
- in adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.9
- in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
An additional Phase 3 study, ATLAS (NCT02531516), is ongoing, evaluating apalutamide in combination with radiotherapy in patients with localised high-risk or locally advanced prostate cancer.13
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using apalutamide, please refer to the Summary of Product Characteristics.8
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.
Learn more at https://innovativemedicine.jnj.com/emea/. Follow us at http://www.linkedin.com/company/jnj-innovative-medicine-emea/.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of apalutamide. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com, or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
*Prof. Alberto Briganti has served as a consultant to Johnson & Johnson; he has not been paid for any media work.
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References
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); 31 May, 2026; Chicago.
2 Taplin, M et al. Perioperative Apalutamide in High-Risk Localized Prostate Cancer. N Engl J Med. 2026. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2603878. Accessed May 2026. doi:10.1056/NEJMoa2603878.
3 Wenzel M, et al. Radical Prostatectomy Versus Radiation Therapy for Locally Advanced and Clinically Nodal Positive Prostate Cancer. Clin Genitourin Cancer. 2025;23(4):102370.
4 Qi R, Moul J. High-Risk Prostate Cancer: Role of Radical Prostatectomy and Radiation Therapy. Oncol Res Treat. 2015;38(12): 639-644.
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.
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.
7 Migliaccio, F.,et al. Salvage radiotherapy with or without hormonal therapy for biochemical recurrence after radical prostatectomy: A systematic review and meta-analysis. Prostate Cancer Prostatic Dis. 2026.
8 European Medicines Agency. ERLEADA Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en.pdf. Accessed May 2026.
9 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/study/NCT03767244. Accessed May 2026.
10 Globocan. Europe Fact Sheet, Prostate Cancer, 2022. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf. Accessed May 2026.
11 Reina Y, Villaquirán C, García-Perdomo HA. Advances in high-risk localized prostate cancer: Staging and management. Current Problems in Cancer. 2023;47(5):100993.
12 Wani M, et al. What Is New in the Management of High-Risk Localized Prostate Cancer? Cancers (Basel). 2022;14(23): 5861.
13 ClinicalTrials.gov. An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS. Available at: https://clinicaltrials.gov/study/NCT02531516. Accessed May 2026.
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