Study of JAK Inhibition in Stem-Like Prostate Cancer (JASPER): A Phase 1b/2a Multicenter Study of Ruxolitinib and Enzalutamide in Castration Resistant Prostate Cancer

This phase I/II tests the safety, side effects and best dose of ruxolitinib in combination with enzalutamide and how well it works in treating patients with prostate cancer that remains despite blocking hormone production (castration-resistant) and that has spread from where it first started to other places in the body (metastatic). Ruxolitinib, a kinase inhibitor, slows down the growth of the tumor by blocking the proteins, JAK1 and JAK2, tumors use to grow. Enzalutamide, an androgen receptor inhibitor, works by blocking the effects of androgen (a male reproductive hormone). This may help stop the growth and spread of tumor cells that need testosterone to grow. Giving ruxolitinib in combination with enzalutamide may be safe, tolerable, and/or effective in treating metastatic castration-resistant prostate cancer.

Start Date30 Jan 2026

Sponsor / Collaborator

Rogel Cancer Center: University of Michigan

[+1]

NCT07226986

/ RecruitingPhase 1/2

A Phase Ib/II Open-label, Multi-center Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With an Androgen Receptor Pathway Inhibitor (ARPI) in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter referred to as AAA617) with an androgen receptor pathway inhibitor (ARPI) in participants with metastatic castration resistant prostate cancer (mCRPC) who have failed one prior ARPI and with or without prior taxane exposure, and (b) in Phase II evaluate the preliminary efficacy of AMO959 in combination with AAA617 and ARPI in participants with mCRPC who have failed one prior ARPI, but who have not yet been exposed to taxane treatment.

Start Date16 Dec 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT07277270

/ Not yet recruitingPhase 1/2

A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors

The goal of this clinical trial is to test a new medicine called GSK5764227, which delivers a toxin directly to cancer cells to destroy them while sparing healthy cells. The study will combine GSK5764227 with standard treatments to evaluate its safety, examine how the body processes it, check if it triggers any immune responses, and assess whether it can shrink or control cancer.

Start Date08 Dec 2025

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Enzalutamide

100 Translational Medicine associated with Enzalutamide

100 Patents (Medical) associated with Enzalutamide

4,232

Literatures (Medical) associated with Enzalutamide

31 Dec 2025·CANCER BIOLOGY & THERAPY

Assessing the potential for in vivo modulation of FTH1 gene expression with small peptides to restore and enhance androgen receptor pathway inhibition in prostate cancer

Article

Author: Nicol, McKayla ; Kumar, Sateesh ; Currie, Crawford ; Framroze, Bomi ; Bjerknes, Christian

Increased levels of intratumoral free iron drive more aggressive behavior with the development of treatment resistance and spread in a range of cancers including prostate cancer (PCa). This phenotype is associated with an increase in TFRC expression and a decrease in FTH1, a profile supporting increased iron acquisition. In this study we investigated the anti-oncogenic effects of two small peptides (FT-002 and FT-005) that upregulate FTH1 expression and downregulate TFRC expression when combined with standard androgen receptor pathway inhibitors (ARPIs) in xenograft models of PCa in male athymic nude mice. The PC3 cell line was used to establish xenografts representing highly aggressive, androgen-resistant PCa and the LNCaP cell line as a model of androgen-sensitive PCa. Both peptides enhanced the anti-tumor efficacy of ARPI therapy. Efficacy was more marked with the combination of the second-generation APRI enzalutamide than the first-generation agent bicalutamide, a result consistent with known resistance mechanisms to different ARPI therapy. Further, the FT-peptide/enzalutamide combination drove tumor regression whereas enzalutamide monotherapy only slowed growth, even in the hormone-sensitive xenograft. The FT-002a-enzalutamide combination was more effective than FT-005 in reducing tumor mass and volume and modulating FTH1 and TFRC expression. The reversal by the peptides of this oncogenic expression pattern points to a reduction in the tumor free iron via increased iron storage in ferritin and a reduction in iron influx via the transferrin receptor. Peptide-mediated modulation of tumor iron metabolism may therefore offer a novel means to enhance ARPI efficacy and delay resistance in advanced prostate cancer.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of enzalutamide with androgen-deprivation therapy (ADT) versus ADT alone for the treatment of high-risk biochemically recurrent non-metastatic castration-sensitive prostate cancer in Canada

Article

Author: Aprikian, Armen ; Johnston, Karissa ; McLean, Thomas ; Chilelli, Andrew ; Li, Yuxin ; Saad, Fred ; Wywial, Ewa

AIM:

The EMBARK (NCT02319837) trial demonstrated that enzalutamide with androgen-deprivation therapy (ADT; enzalutamide combination) or without ADT (enzalutamide monotherapy) significantly improved metastasis-free survival compared with ADT alone in high-risk biochemically recurrent (BCR) non-metastatic castration-sensitive prostate cancer (nmCSPC; also known as non-metastatic hormone-sensitive prostate cancer [nmHSPC]). No new safety signals were observed during the trial. The findings of EMBARK led to Health Canada's approval of enzalutamide for this patient population. The aim of this analysis was to assess the cost-effectiveness of enzalutamide combination versus ADT alone in patients with high-risk BCR nmCSPC from the Canadian payer's perspective.

MATERIAL AND METHODS:

A semi-Markov model was created to represent the treatment and disease progression of patients with high-risk BCR nmCSPC over a 30-year horizon. Costs and outcomes were discounted at 1.5% annually. Treatment effects for high-risk BCR nmCSPC were informed by data from the EMBARK trial. Life-years (LYs), quality-adjusted life-years (QALYs), lifetime costs and incremental cost-effectiveness ratio (ICER) were estimated for enzalutamide combination and ADT alone. A one-way sensitivity analysis (OWSA) and scenario analyses were conducted to assess the robustness of results.

RESULTS:

In the base-case deterministic analysis over the modeled time horizon, enzalutamide combination accumulated 11.85 LYs and 8.96 QALYs versus 8.75 LYs and 6.24 QALYs for ADT alone. The total cost for enzalutamide combination was Canadian dollars (CAD) 166,199, compared with CAD 95,146 for ADT alone. When combining cost and clinical outcome data, enzalutamide combination was associated with an ICER of CAD 26,129 per QALY gained. The OWSA and scenario analysis results were consistent with the base-case results.

CONCLUSION:

The study findings suggest that enzalutamide combination was associated with an ICER of CAD 26,129 per QALY gained, which is within the standard Canadian thresholds for willingness-to-pay (i.e.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Healthcare resource utilization and costs among patients with metastatic castration-sensitive prostate cancer initiated on apalutamide or enzalutamide in the United States (2019–2023)

Article

Author: Khilfeh, Ibrahim ; Bilen, Mehmet A. ; Joshi, Kruti ; Rossi, Carmine ; Du, Shawn ; Lowentritt, Benjamin ; Shore, Neal D. ; Pilon, Dominic ; Wong, Gordon ; Burbage, Sabree ; Kinkead, Frederic

AIMS:

This retrospective longitudinal cohort study compared healthcare resource utilization (HRU) and costs among patients with metastatic castration (hormone)-sensitive prostate cancer who initiated apalutamide or enzalutamide, two androgen receptor pathway inhibitors (ARPIs) that have demonstrated efficacy in the treatment of advanced prostate cancer in phase 3 clinical trials.

METHODS:

Linked patient-level data from a practice-related clinical urology database and an administrative claims database in the United States (1 January 2016-31 December 2023) were used. Per-patient-per-month (PPPM) HRU and cost outcomes were compared between the apalutamide and enzalutamide cohorts during the observation period (i.e. from ARPI initiation until continuous insurance eligibility end) after inverse probability treatment weighting to balance differences in baseline characteristics.

RESULTS:

Overall, 486 patients who initiated apalutamide (mean age 70.3 years, 53.5% white, 25.4% Black, 58.1% Medicare-insured) and 601 patients who initiated enzalutamide (mean age 70.5 years, 52.9% white, 25.5% Black, 58.8% Medicare-insured) were included. Duration of continuous treatment use was 9.6 months for apalutamide and 8.6 months for enzalutamide. Despite longer continuous ARPI use among patients treated with apalutamide relative to enzalutamide, the number of inpatient admissions (rate ratio [RR] = 0.58; 95% confidence interval [CI] = 0.37, 0.86; p = 0.012), number of admission days (RR = 0.58; 95% CI = 0.19, 0.70; p = 0.004), as well as all-cause medical costs (mean monthly cost difference = -$1,845; 95% CI = -$52, -$4,908; p = 0.044) were significantly lower in the apalutamide cohort than the enzalutamide cohort during the observation period. Mean monthly all-cause pharmacy costs between the cohorts was not significantly different ($2,121; 95% CI = -2,389, 5,703; p = 0.320).

LIMITATIONS:

This study relied on administrative claims and clinical data, which may contain coding inaccuracies or omissions. While linkages between the data sources are comprehensive, any mislinkages may have led to misclassification and information bias.

CONCLUSION:

The findings of this study suggest that apalutamide may result in better economic outcomes relative to enzalutamide.

687

News (Medical) associated with Enzalutamide

08 Dec 2025

·www.globenewswire.com

Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding Agreement

Dec. 04, 2025 -- Denali Therapeutics Inc. (Nasdaq: DNLI) and Royalty Pharma plc (Nasdaq: RPRX) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa. Tividenofusp alfa is Denali’s lead investigational TransportVehicle™-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or Hunter syndrome). A Biologics License Application (BLA) for accelerated approval of tividenofusp alfa is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of April 5, 2026. “We are pleased to partner with Royalty Pharma, whose investment recognizes the value and potential of tividenofusp alfa for the Hunter community and supports our ability more broadly to realize the promise of the TransportVehicle platform,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “With these additional funds, we are well positioned to advance our development programs as we prepare for the launch of tividenofusp alfa, unlocking broad opportunities across serious diseases.” “We are delighted to partner with Denali and acquire a royalty on tividenofusp alfa, an innovative therapy that addresses a significant unmet need in the cognitive and physical manifestations of Hunter syndrome,” said Pablo Legorreta, Chief Executive Officer and Chairman of the Board of Royalty Pharma. “Denali’s technology platform delivers therapeutics across the blood-brain barrier and is a promising new approach to brain diseases. We are thrilled to establish a relationship with Denali and believe tividenofusp alfa is a potential practice-changing therapy that could transform the lives of patients with Hunter syndrome.” The transaction is subject to various closing conditions, including Denali achieving U.S. FDA accelerated approval of tividenofusp alfa. At the closing, Royalty Pharma will make an initial payment of $200 million and Royalty Pharma will be obligated to make an additional payment of $75 million upon achieving European Medicines Agency (EMA) approval of tividenofusp alfa by December 31, 2029. In exchange, Royalty Pharma will receive a 9.25% royalty on worldwide net sales of tividenofusp alfa from Denali. The royalty payments to Royalty Pharma will cease upon reaching a multiple of 3.0x, or 2.5x if achieved by the first quarter of 2039. Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier using its proprietary TransportVehicle™ platform. With a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, Denali is advancing toward its goal of delivering effective medicines to transform the lives of people living with neurodegenerative, lysosomal storage and other serious diseases. Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly – directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products, including Vertex’s Trikafta and Alyftrek, GSK’s Trelegy, Roche’s Evrysdi, Johnson & Johnson’s Tremfya, Biogen’s Tysabri and Spinraza, Servier’s Voranigo, AbbVie and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s Xtandi, Pfizer’s Nurtec ODT, and Gilead’s Trodelvy, and 18 development-stage product candidates. The content above comes from the network. if any infringement, please contact us to modify.

26 Nov 2025

·www.fiercepharma.com

Medicare unveils price reductions for 15 drugs, including Novo's semaglutide

Centers for Medicare & Medicaid Services Administrator Mehmet Oz, M.D., said that new Inflation Reduction Act-mandated Medicare prices for 15 prescription drugs "stand in stark contrast " to "counterproductive 'deals' we saw before," under the Biden administration. The U.S. has revealed price reductions for the second round of prescription drugs negotiated by the Centers for Medicare & Medicaid Services (CMS) through the Inflation Reduction Act (IRA). Headlining the list of 15 treatments that will undergo price reductions in 2027 are Novo Nordisk’s semaglutide products, Ozempic and Wegovy.The negotiated price for Ozempic is $274 per month compared to the current list price of $959. Meanwhile, the new price for higher doses of Wegovy will be $385 per month, according to a CMS document. The adjusted prices are what Medicare will pay drugmakers for the medicines.Prices for drugs on the list have been slashed by between 38% and 85%, according to CMS. The discounts will cut Medicare’s costs for the 15 drugs by 44% and save taxpayers roughly $12 billion per year from prior spending levels, the agency said.While pushing for lower drug prices through his Most Favored Nation (MFN) plan, President Donald Trump has largely downplayed the IRA as a tool for achieving them. The program was established in 2022 under President Joe Biden. Medicare price reductions go into effect at the start of next year for the initial round of 10 drugs selected for negotiations.“This year’s results stand in stark contrast to last year’s,” said CMS Administrator Mehmet Oz, M.D., in a release. “Using the same process with a bolder direction, we have achieved substantially better outcomes for taxpayers and seniors in the Medicare Part D program—not the modest or even counterproductive ‘deals’ we saw before.”Next year, another round of 15 drugs will be selected for price reductions that will go into effect in 2028. That will be followed by a round of 20 drugs that will see price reductions in 2029.On the list of newly announced price reductions are two drugs from AbbVie. Antipsychotic treatment Vraylar was slashed from a list price of $1,376 per month to $770, while irritable bowel syndrome medicine Lynzess was adjusted from $539 to $136 per month. Also on the list are two drugs: Boehringer Ingelheim. Lung disease drug Ofev will see a reduction from $12,622 to $6,350 per month, while the price of Type 2 diabetes treatment Tradjenta was cut from $488 to $78 per month.GSK has two drugs on the list as well, both to treat COPD and asthma. The price of Breo Ellipta was reduced from $397 to $67 per month, while the monthly price of newer Trelegy Ellipta was cut from $654 to $175.The most expensive drugs on the list are cancer treatments, topped by Bristol Myers Squibb’s multiple myeloma treatment Pomalyst, which will see a monthly price slash from $21,744 to $8.650. Pfizer’s breast cancer drug Ibrance will be cut from $15,741 to $7,871 per month, according to the CMS document.The price for AstraZeneca’s blood cancer drug Calquence has been cut from $14,228 to $8,600, while Pfizer and Astellas have seen the monthly price of their prostate cancer treatment Xtandi reduced from $13,480 to $7,004.Also slashed were prices for Salix’s gastrointestinal treatment Xifaxan, from $2,696 to $1,000 per month; Amgen’s psoriasis drug Otezla, from $4,722 to $1,650; Merck’s Type 2 diabetes treatments Januvia and Janumet, from $526 to $80 per month; and Teva’s movement disorders drug Austedo, which goes from $6,623 to $4,093. As for the price reductions for the highest-profile drugs on the list, Ozempic and Wegovy, a Novo spokesperson said that the company continues “to have serious concerns about the Inflation Reduction Act’s impact on patients” and that it remains “opposed to government price setting.”“We have seen that government price setting has not translated to lower out-of-pocket costs for patients and can lead to a loss of coverage for medications and higher insurance premiums,” the spokesperson said. “We will continue to work with stakeholders and policymakers to expand affordable access to our medicines through both government and commercial insurance plans.”

25 Nov 2025

·firstwordpharma.com

CMS reveals pricing discounts for 15 drugs under second round of IRA negotiations

The Centers for Medicare and Medicaid Services (CMS) on Tuesday released the negotiated costs of the second batch of drugs subject to pricing negotiations, for net savings of 44% or roughly $12 billion, compared to 2024 Medicare net spending on the products.The prices for the 15 drugs, negotiated by Medicare under the Inflation Reduction Act (IRA), will go into effect January 2027. The group features Novo Nordisk's obesity and diabetes medication Wegovy/Ozempic (semaglutide); GSK's asthma therapy Trelegy Ellipta; Astellas' prostate cancer treatment Xtandi; Boehringer Ingelheim's idiopathic pulmonary fibrosis drug Ofev; and Pfizer's breast cancer therapy Ibrance. Discounted pricing for the first batch of 10 drugs subject to negotiations, which included Merck & Co.'s diabetes medication Januvia and Bristol Myers Squibb's anticoagulant Eliquis, will go into effect at the start of 2026. 71% discount for semaglutideAccording to CMS, throughout 2024, about 5.3 million people with Medicare Part D coverage were prescribed the 15 drugs — which accounted for about $42.5 billion in total prescription drug costs during that period, or 15% of Medicare Part D's total spend. Semaglutide topped the list with both the highest number of Medicare Part D users — 2.3 million — and the largest spend of $15.2 billion. Novo agreed to a 71% discount for the GLP-1 agonist, for a $274 monthly cost. However, the negotiated price is slightly higher than the Danish drugmaker's agreement with the Trump administration earlier this month. Under a most-favoured nations drug pricing deal, Novo Nordisk said it would make Wegovy available at $350 per month on the direct-to-consumer platform TrumpRx, while the Medicare prices for both the Ozempic and Wegovy brands would be $245 per month, with beneficiary co-pays pegged at $50 per month. The company's stock didn't react to CMS's pricing reveal during after-hours trading Tuesday.Out-of-pocket savingsThe drug that Medicare Part D spent the next-most on was Trelegy Ellipta, accounting for $5.3 billion of its 2024 spend. GSK agreed to a 73% discount to bring the drug's monthly cost down to $175. The negotiated Medicare prices for Xtandi, Ofev and Ibrance were about half their 2024 costs, for new monthly costs of $7,004, $6,350 and $7,871, respectively. According to CMS, when the negotiated prices go into effect in 2027, Medicare recipients will save an estimated $685 million in out-of-pocket costs.

Accelerated ApprovalFinancial Statement

100 Deals associated with Enzalutamide

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KEGG	Wiki	ATC	Drug Bank
D10218	Enzalutamide	L02BB04	DB08899

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Prostatic Cancer	South Korea	Astellas Pharma Korea, Inc.	03 Dec 2024
Castration-sensitive prostate cancer	United States	Astellas Pharma US, Inc.	16 Nov 2023
HRR Gene-mutated Castration-Resistant Prostate Cancer	United States	Pfizer Inc.	20 Jun 2023
Metastatic Prostate Carcinoma	Japan	Astellas Pharma, Inc.	29 May 2020
Castration-Resistant Prostatic Cancer	European Union	Astellas Pharma Europe Ltd.	21 Jun 2013
Castration-Resistant Prostatic Cancer	Iceland	Astellas Pharma Europe Ltd.	21 Jun 2013
Castration-Resistant Prostatic Cancer	Liechtenstein	Astellas Pharma Europe Ltd.	21 Jun 2013
Castration-Resistant Prostatic Cancer	Norway	Astellas Pharma Europe Ltd.	21 Jun 2013
Hormone-dependent prostate cancer	European Union	Astellas Pharma Europe Ltd.	21 Jun 2013
Hormone-dependent prostate cancer	Iceland	Astellas Pharma Europe Ltd.	21 Jun 2013
Hormone-dependent prostate cancer	Liechtenstein	Astellas Pharma Europe Ltd.	21 Jun 2013
Hormone-dependent prostate cancer	Norway	Astellas Pharma Europe Ltd.	21 Jun 2013
Metastatic castration-resistant prostate cancer	United States	Astellas Pharma US, Inc.	31 Aug 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Triple-Negative Breast Carcinoma	Phase 3	United States	Astellas Pharma, Inc.	01 Sep 2016
Advanced Triple-Negative Breast Carcinoma	Phase 3	United States	Pfizer Inc.	01 Sep 2016
Advanced Triple-Negative Breast Carcinoma	Phase 3	United States	MediVation, Inc.	01 Sep 2016
Adenocarcinoma of prostate	Phase 3	United States	Astellas Pharma US, Inc.	22 Jan 2014
Adenocarcinoma of prostate	Phase 3	United States	MediVation, Inc.	22 Jan 2014
Adenocarcinoma of prostate	Phase 3	Canada	MediVation, Inc.	22 Jan 2014
Adenocarcinoma of prostate	Phase 3	Canada	Astellas Pharma US, Inc.	22 Jan 2014
Recurrent Prostate Carcinoma	Phase 3	United States	Astellas Pharma US, Inc.	22 Jan 2014
Recurrent Prostate Carcinoma	Phase 3	United States	MediVation, Inc.	22 Jan 2014
Recurrent Prostate Carcinoma	Phase 3	Canada	Astellas Pharma US, Inc.	22 Jan 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02319837 (EMBARK, Pubmed \| J Urol)	Phase 3	Non-metastatic prostate cancer	468	Enzalutamide plus leuprolide	yqszzcirnk(mdbunkzmkm) = fznkfexnsw uzzvypfpbx (bjhgcuxzfj, 83.0 - 90.4) View more	Positive	05 Dec 2025
				Enzalutamide monotherapy	yqszzcirnk(mdbunkzmkm) = leezskixjb uzzvypfpbx (bjhgcuxzfj, 85.6 - 92.4) View more
NCT03751436 (Pubmed \| Cancer Chemother Pharmacol)	Phase 1	Metastatic castration-resistant prostate cancer BCL-2	10	Enzalutamide (160 mg/d) with Venetoclax (metastatic castration-resistant prostate cancer)	zjiydkdevz(tpwglomxsx) = awehjifweq obujiujugb (uwdtlgetsz, 1 - 35) View more	Positive	01 Dec 2025
NCT02203695 (SALV-ENZA, CTgov)	Phase 2	Non-metastatic prostate cancer \| Adenocarcinoma of prostate	86	Enzalutamide (SRT Plus Enzalutamide)	fkuoyygeew = yfxqousyre dldxcqnoly (lakbhewgkl, dtcjwnkref - doizlrzgpy) View more	-	24 Oct 2025
				SRT (SRT Plus Placebo)	fkuoyygeew = rgobugwyuy dldxcqnoly (lakbhewgkl, unigycijbn - ucvqvpljel) View more
NCT02319837 (EMBARK, N Engl J Med \| Company_Website \| ESMO2025) Manual	Phase 3	Non-metastatic prostate cancer	1,068	Enzalutamide + Leuprolide	ivgyzsiepl(bturojbzde) = pmzjrpowta vcdgbnlalh (rdfezhmwoz, 73.9 - 83.1)	Positive	19 Oct 2025
				Enzalutamide monotherapy	ivgyzsiepl(bturojbzde) = pznljqucei vcdgbnlalh (rdfezhmwoz, 67.6 - 77.9)
NCT02319837 (EMBARK, Pubmed \| N Engl J Med)	Phase 3	Non-metastatic prostate cancer	823	Enzalutamide plus leuprolide	etmfnbfope(htievkbqup) = fjjkdryrcw hrwneprmxh (spcrhzbayw, 73.9 - 83.1)	Positive	19 Oct 2025
				Leuprolide alone	etmfnbfope(htievkbqup) = bsvpzdeyxi hrwneprmxh (spcrhzbayw, 64.0 - 74.3)
NCT02319837 (EMBARK, ESMO2025)	Phase 3	Non-metastatic prostate cancer	1,068	Enzalutamide + Leuprolide	lyglinsfol(imqtujgmkj): HR = 0.597 (95.0% CI, 0.444 - 0.804), P-Value = 0.0006 View more	Positive	17 Oct 2025
				Leuprolide
NCT02446405 (ENZAMET, ESMO2025)	Phase 3	Hormone-dependent prostate cancer	1,125	Docetaxel + Enzalutamide	yloofoxrjd(uucqbsqppk): HR = 1.02 (95.0% CI, 0.92 - 1.12), P-Value = 0.72	Negative	17 Oct 2025
				No Docetaxel + Enzalutamide
NCT02319837 (EMBARK, ESMO2025)	Phase 3	Prostatic Cancer	1,138	Enzalutamide + Leuprolide	iucmbpxqog(cthtptxliy) = wqildpusvu cwzcdzcqrt (vurcoukhdg ) View more	Positive	17 Oct 2025
				Leuprolide	iucmbpxqog(cthtptxliy) = cwyjwsuqiv cwzcdzcqrt (vurcoukhdg ) View more
NCT00268476 (STAMPEDE, ESMO2025)	Phase 3	Hormone-dependent prostate cancer	6,292	ADT alone (M0)	nzkdsbqvlv(qewanhxxnr) = jlgncriafg bcfztnbrvx (lcdozeoyij, 12 - 22) View more	Negative	17 Oct 2025
				ADT alone (M1)	nzkdsbqvlv(qewanhxxnr) = pzhysvxdoe bcfztnbrvx (lcdozeoyij, 5 - 10)
ESMO2025	Not Applicable	Castration-sensitive prostate cancer	455	Darolutamide + Docetaxel	xpvwgizlqa(fpgvtdjtyi) = aybbivkatk fzgimtsrev (yjtbvbikqy )	Positive	17 Oct 2025
				Apalutamide	xpvwgizlqa(fpgvtdjtyi) = leszfkcirs fzgimtsrev (yjtbvbikqy )

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