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An alternate regimen of docetaxel (50 mg/m² once every 2 weeks instead of 75 mg/m² once every 3 weeks) plus darolutamide (Nubeqa) and androgen deprivation therapy (ADT) demonstrated statistically highly significant and clinically meaningful improvements in grade 3–5 adverse event (AE) rates as well as grade 3–4 neutropenia or death of any reason rates in patients with metastatic hormone-sensitive prostate cancer.¹

The findings, from the phase 3 ARASAFE study (NCT05676203), were presented at the 2025 European Society for Medical Oncology Congress in Berlin, Germany by Marc-Oliver Grimm, MD, professor and chair of urology at Jena University Hospital in Jena, Germany.

By way of background, Grimm explained that the use of ADT, darolutamide, and docetaxel is FDA approved for patients with mHSPC based on findings from the phase 3 ARASENS trial (NCT027996602). In that regimen, the docetaxel dosage is 75 mg/m² once every 3 weeks. However, Grimm pointed out that toxicity such as neutropenic complications could limit the use of this regimen compared with androgen receptor pathway inhibitor/ADT doublet therapy. For ARASAFE, Grimm and his co-authors sought to evaluate toxicity in triplet therapy with darolutamide/ADT/docetaxel with docetaxel dosages of 50 mg/m² once every 2 weeks and 75 mg/m² once every 3 weeks.

“We hypothesized that triplet therapy with darolutamide, ADT, and 50 mg[/m²] every 2 weeks reduces grade 3 to 5 adverse events compared to the standard 75-mg[/m²] schedule,” Grimm said. Grimm also pointed to previous research indicating that ADT plus docetaxel 50 mg/m² once every 2 weeks was associated with better time to treatment failure and fewer grade 3–4 AEs in patients with metastatic castration-resistant prostate cancer.³

In ARASAFE, a total of 250 patients with mHSPC were randomly assigned 1:1 to darolutamide 600 mg twice daily plus ADT plus 6 cycles of docetaxel 75 mg/m² once every 3 weeks (3-week cycle, 129 patients) or to darolutamide 600 mg twice daily plus ADT plus 6 cycles of docetaxel 50 mg/m² once every 2 weeks (4-week cycle, 121 patients). Total expected docetaxel dose was 450 mg/m² in the 75 mg/m² arm vs 600 mg/m² in the 50 mg/m² arm.

Primary end points included grade 3-5 AEs and grade 3-4 neutropenia or death of any reason. Secondary end points included time to castration resistant prostate cancer, overall survival, time to pain progression, time to first symptomatic skeletal event, time to initiation of subsequent systemic antineoplastic therapy, time to worsening of disease-related physical symptoms, and quality of life.

Median age at baseline was 68.0 years (IQR, 63.0–74.0 years) in the 75 mg/m² arm vs 67.0 years (IQR, 63.0–73.0 years) in the 50 mg/m² arm. High-volume disease was present in 108 (83.7%) patients in the 75 mg/m² arm vs 104 (86.0%) patients in the 50 mg/m² arm. Mean number of docetaxel doses was 5.6 (standard deviation [SD], 1.1) in the 75 mg/m² arm vs 10.7 (SD, 2.2) in the 50 mg/m² arm. Mean cumulative docetaxel dose was 842.8 mg (SD, 181.7 mg) in the 75 mg/m² arm vs 1073.5 mg (SD, 240.4 mg) in the 50 mg/m² arm.

Grimm reported that the study reached its primary end points: The grade 3-5 AE rate was 78.9% (95% CI, 70.8%–85.6%) in the 75 mg/m² arm vs 61.2% (95% CI, 51.9%–69.9%) in the 50 mg/m² arm (P =.0024). Additionally, the grade 3–4 neutropenia/death of any reason rate was 64.1% (95% CI, 55.1%–72.3%) in the 75 mg/m² arm vs 24.0% (95% CI, 16.7%–32.6%) in the 50 mg/m² arm (P <.00001).

Grimm also reported that the rates of neutropenia, leukopenia, and febrile neutropenia favored the 50 mg/m² dosage over the 75 mg/m² dosage.

The investigators utilized prostate-specific antigen (PSA) response at week 26 as a putative surrogate for oncologic outcome. Grimm reported that the median PSA level in the 75 mg/m² arm was 0.16 ng/mL (IQR, 0.03 ng/mL–1.00 ng/mL) vs 0.26 ng/mL (IQR, 0.05 ng/mL–1.55 ng/mL) in the 50 mg/m² arm. PSA levels of 0.2 ng/mL or lower were observed in 63 (48.8%) patients in the 75 mg/m² arm vs 50 (41.3%) patients in the 50 mg/m² arm.

“In summary, ARASAFE demonstrates a statistically highly significant and clinically meaningful reduction in the incidence of grade 3 to 5 adverse event rate and the rate of grade 3 to 4 neutropenia or death regardless of reason for the experimental approach. This was achieved despite higher total doses of docetaxel in the experimental arm. Therefore, the ARASAFE approach may be considered a potential new standard of care,” Grimm said in his concluding remarks.

DISCLOSURES: Grimm noted advisory board/invited speaker/institutional associations with AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen Pharma, Merck Serono, MSD, Pfizer, Roche, Eisai, Janssen Cilag, Gilead, Novartis, Telix, Astellas, Kranus, Recordati, Janssen, and Intuitive Surgical.

REFERENCES:

1. Grimm M-O, Von Amsberg G, Heers H, et al. 3-weekly docetaxel 75 mg/m2 vs 2-weekly docetaxel 50 mg/m2 in combination with darolutamide + ADT in patients with mHSPC: Results from the randomised phase III ARASAFE trial. Presented at: European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. LBA92. https://tinyurl.com/vs3p8wh3

2. FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer. Published online August 5, 2022. Accessed October 17, 2025. https://tinyurl.com/yhjw2sw2

3. Kellokumpu-Lehtinen P-K, Harmenberg U, Joensuu T, et al. 2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial. Lancet Oncol. 2013;14(2):117-24. doi:10.1016/S1470-2045(12)70537-5

Expanding Trades Opportunities in Arizona

Phoenix, AZ and New York, NY – The Blackstone Charitable Foundation has awarded a $3 million grant to launch Blackstone Skilled Futures in partnership with Arizona State University, Maricopa Community Colleges and local nonprofits. The program aims to increase access to high-quality training and workforce development, focusing on construction and advanced manufacturing in the Phoenix area.

Blackstone Skilled Futures will support students in need, along with capacity building for training institutions and other wraparound support to ensure learners can get the education, certifications, and employment in these fields.

The initiative will also support high school students with career-connected programming, creating workforce pipelines into post-secondary training and industry credentials in high-wage, high-demand, and high-skill jobs in the skilled trades.

Arizona’s rapid growth in electric vehicles, AI, energy infrastructure and semiconductors is fueling a construction and advanced manufacturing boom. The Arizona Office of Economic Opportunity projects 37,000 new construction jobs will be added in Arizona by 2031, including 13,000 electricians and 3,000 HVACR (heating, ventilation, air conditioning and refrigeration) technicians. Job demand in advanced manufacturing parallels this trend, with the state expecting to add over 30,000 jobs by 2033.

“It’s getting harder and harder for people to find good-paying, stable jobs without a college degree, but this investment helps change that,” said Senator Ruben Gallego. “By preparing Arizona students for careers in high-demand fields like construction, manufacturing and energy, we can strengthen our local businesses, keep our state competitive, and help more people build their careers and families in Arizona.”

Blackstone Skilled Futures plans to:

• Award scholarships to 4,000 students
• Introduce skilled trades to 3,500 new students
• Enroll 5,000 students in training or apprenticeships
• Support 1,000 job placements

The program will provide scholarships, dual-enrollment credits, OSHA training, recruitment tools and connections to employers. ASU’s Academic Alliances, in partnership with the OSHA Training Institute at ASU’s Del E. Webb School of Construction and Maricopa Community Colleges, will expand training and certificate programs.

“The demand for skilled trades is growing and these careers are the backbone of a thriving Arizona community. The Blackstone Charitable Foundation is committed to opening doors for individuals to gain the training, tools and opportunities they need to succeed. By investing in skilled trades, we’re not just helping to meet today’s demand, we’re supporting a stronger future for the city and the people who call it home,” said Maura Pally, executive director of the Blackstone Charitable Foundation.

“ASU is honored to work closely on this grant with the Blackstone Charitable Foundation and the Maricopa Community Colleges, one of the university’s most valued community college partners,” said Nancy Gonzales, executive vice president and university provost. “We share a mission of student excellence, access and impact and this collaboration is a direct reflection of ASU’s commitment to transfer student success.”

The colleges and university will collaborate with Center for the Future of Arizona (CFA), Greater Phoenix Chamber of Commerce, Phoenix Mayor’s Future Talent Fund and Maricopa County Regional School District to increase the number of students pursuing these skilled trades.

Center for the Future of Arizona will connect education and industry leaders to build seamless college and career pathways in high-demand sectors through the Arizona Pathways to Prosperity initiative. The organization will engage school districts, nonprofit organizations, municipalities, state agencies, companies and chambers of commerce – to recruit students and provide technical assistance and scholarships. CFA will continue collaborating with the Greater Phoenix Chamber Foundation to support employer outreach.

“Building the workforce of the future requires collaboration, innovation, and a deep commitment to creating opportunity through education and training,” said Sybil Francis, chair, president and CEO of Center for the Future of Arizona. “We are proud to join the Blackstone Charitable Foundation, ASU, and Maricopa Community Colleges in creating pathways that empower young people across Arizona to pursue rewarding, high-skill careers. Together, we’re providing all Arizonans with access to training and opportunities to help them thrive.”

At the same time, the Maricopa Community Colleges will lead localized engagement efforts, which include expanding scholarships for low-income students, securing industry partners to serve as hosts and training providers for apprenticeships, facilitating work-based learning and career support activities such as resume reviews and mock interviews, and convening industry advisory councils to inform curriculum updates and identify student engagement opportunities.

“Maricopa Community Colleges have a rich history of training skilled workers,” said Steven R. Gonzales, Maricopa Community Colleges chancellor. “As the largest provider of workforce training in Arizona, we are developing the next generation of skilled workers—who will undoubtedly play a critical role in supporting nearly every facet of our infrastructure.”

Collectively, the partners will reach a variety of populations who can benefit from these skilled trades opportunities, including high school students, community college students and working adults to rapidly scale access to high-wage, high-demand careers.

About Arizona State University
Arizona State University, ranked the No. 1 “Most Innovative School” in the nation by U.S. News & World Report for 11 years in succession, has forged the model for a New American University by operating on the principles that learning is a personal and original journey for each student; that they thrive on experience and that the process of discovery cannot be bound by traditional academic disciplines. Through innovation and a commitment to accessibility, ASU has drawn pioneering researchers to its faculty even as it expands opportunities for qualified students.

About Blackstone Charitable Foundation (BXCF)
With a commitment to fostering career and economic mobility, the Blackstone Charitable Foundation leverages its financial and human capital to support initiatives that bridge opportunity gaps and strengthen communities. Blackstone Skilled Futures is BXCF’s latest grant program, aiming to expand the next generation of skilled talent by reducing barriers and increasing access to high-quality training programs in the trades. BXCF has also funded the Phoenix talent pipeline through Blackstone LaunchPad, with over $1.5 million in grants to support ASU and MCCCD students in skill-building, career readiness and paid summer internships.

About Maricopa Community Colleges
The Maricopa County Community College District includes 10 individually accredited colleges – Chandler-Gilbert, Estrella Mountain, GateWay, Glendale, Mesa, Paradise Valley, Phoenix, Rio Salado, Scottsdale, and South Mountain – and the Maricopa Corporate College, serving approximately 140,000 students with bachelor’s degrees, two-year degrees, certificates, and university transfer programs. Visit www.maricopa.edu to learn more.

About Center for the Future of Arizona
Center for the Future of Arizona (CFA) is a nonprofit, nonpartisan “do-tank” that brings Arizonans together to create a stronger and brighter future for our state. Through its extensive survey research & communications, Arizona Progress Meters, and impact initiatives & programs in education, workforce, and civic health, CFA listens to Arizonans to learn what matters most to them, shares trusted data about how Arizona is doing in those priority areas, brings critical issues to public attention, and works with communities and leaders to solve public problems. CFA’s work is focused on building The Arizona We Want – a research-informed vision of success for the state, where all Arizonans, now and in the future, thrive and enjoy sustained prosperity, unmatched quality of life, and real opportunity.

Media Contact
Avery Didden
[email protected]