LAST WEEK TODAY!

A summary of what was published on ProstateWarriors.com during the past week

Hi fellow warriors! This week we have “only” four news items, but they are very good, especially the update on the ARCHES trial. Stay strong and fight on!

As usual, we also have a podcast if you prefer to listen to the newsletter, you can find it HERE.​

Clinical Research

• Phase 2 Low-Dose Abiraterone Acetate for mCRPC​
  A recent study published in JCO Global Oncology indicates that a smaller, 250-milligram dose of abiraterone acetate (AA) taken with a low-fat meal is as effective as the standard 1,000-milligram dose taken on an empty stomach for metastatic castration-resistant prostate cancer (mCRPC). This approach slashes the required drug amount by 75% because food boosts its absorption. The Brazilian study tracked 96 patients over two years, showing that 60.2% experienced at least a 50% drop in PSA levels after 12 weeks, with a 68.3% response rate for those in earlier treatment stages. Patients had an average of 7.9 months before disease progression and an overall survival of 20.6 months. These results compare favorably to major international trials of the standard dose, which reported PSA response rates from 29.5% to 62% and survival times from 14.8 to 34.7 months. The low-dose regimen also demonstrated a gentler side-effect profile. Beyond its clinical benefits, this reduced dose dramatically cuts costs, making it more accessible.
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• ARCHES Trial Follow-up: Enzalutamide Plus ADT​
  The ARCHES trial, initially making news in 2019, demonstrated that combining enzalutamide with androgen deprivation therapy (ADT) significantly reduced the risk of cancer progression by over 60% in patients with metastatic hormone-sensitive prostate cancer (mHSPC), leading to FDA approval. Updated data in 2021 further revealed that this treatment also boosted overall survival by approximately 30%. Now, five-year follow-up data from 2025 solidifies these findings, confirming that enzalutamide plus ADT extends survival by 30%, meaning 13% more men are alive at the five-year mark compared to those on ADT alone. This survival benefit is consistent across various patient profiles, including those with high- or low-volume disease, and regardless of age, location, or prior treatments. A particularly significant impact was observed in men with high-volume disease, where their median survival dramatically increased from four years to seven years.​
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• Phase 1 Trial for ITC-6146RO: A New Antibody-Drug Conjugate​
  An Investigational New Drug application for phase 1 clinical trials of ITC-6146RO was submitted to South Korea’s Ministry of Food and Drug Safety on August 29, 2025. ITC-6146RO is an antibody-drug conjugate (ADC) specifically designed to target solid tumors that overexpress the B7-H3 protein, including metastatic castration-resistant prostate cancer. This innovative candidate uses advanced linker and payload technologies to minimize non-specific uptake by healthy cells, thereby reducing off-target effects and enhancing its therapeutic index. B7-H3 is an effective target because it is highly expressed in various cancers but has limited presence in normal tissues. Preclinical studies have shown that ITC-6146RO has potent antitumor effects, long-lasting efficacy, high stability, and a strong safety profile in relevant animal models.
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• Promising Phase 2 Results for 177Lu-DGUL​
  A new radiopharmaceutical called 177Lu-DGUL is showing very promising phase 2 clinical trial results for metastatic castration-resistant prostate cancer (mCRPC) in South Korea, potentially rivaling the established drug Pluvicto. The therapy, which uses lutetium-177 to target prostate-specific membrane antigen (PSMA)-expressing cancer cells, was tested in 91 mCRPC patients, with 78 evaluable for tumor response. It achieved an objective response rate (ORR) of 35.9% according to RECIST v1.1 criteria, with 8.97% of patients experiencing complete tumor disappearance and 26.9% showing significant tumor shrinkage. This ORR is higher than Pluvicto’s 29.8% in the VISION trial. When using prostate cancer-specific criteria (PCWG-modified RECIST v1.1), 177Lu-DGUL’s ORR rose to 41.0%, and with PET/CT imaging (mPERCIST criteria), it soared to 81%. While acknowledging differences in trial design, these results suggest 177Lu-DGUL could have a competitive edge in shrinking tumors. Furthermore, 177Lu-DGUL demonstrated a significantly better safety profile, with xerostomia (dry mouth) affecting only 13.2% of patients compared to 38.8% for Pluvicto, indicating less toxicity to healthy tissues and potentially improved quality of life.

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And…that’s all folks! For today at least!
Please let me know if there is anything I can improve in my newsletters, and let me know if you have enjoyed the podcast.

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Have a great weekend!

Max