LAST WEEK TODAY!

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

Hi fellow warriors! More good news this week! I’d like to take this opportunity to ask you something: would you like me to include a link to the full article on ProstateWarriors.com in the newsletter? So far, I haven’t done it because I know many of you prefer the brevity of the newsletter, but if you’d like, I can start adding the links. Feel free to reply directly to the newsletter to let me know what you think. 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. For more details on everything I talk about here, you can always visit ProstateWarriors.com.​

Clinical Research

• FDA Fast Tracks Novel Combination Therapy for mCRPC​
  The FDA has granted fast track designation to a novel combination therapy for metastatic castration-resistant prostate cancer (mCRPC), aimed at addressing significant unmet medical needs. The regimen combines TRE-515, a first-in-class deoxycytidine kinase (dCK) inhibitor, with 177Lu-PSMA-617 (Pluvicto), an approved radioligand therapy targeting prostate-specific membrane antigen (PSMA). Pluvicto delivers targeted radiation to PSMA-positive cancer cells, which are prevalent in over 80% of prostate cancer cases. The dCK inhibitor, currently in Phase 1 trials, disrupts the nucleoside salvage pathway critical for cancer cell DNA synthesis, enhancing the DNA-damaging effects of the radioligand therapy. Early Phase 1 data indicate TRE-515 is well-tolerated, with no dose-limiting toxicities and stable disease in some patients. This synergistic, precision oncology approach, using PSMA as a biomarker, offers hope for patients who have exhausted other treatment options.
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• New Phase 3 Trial Approved for Masitinib in mCRPC​
  Regulatory authorities in the United States and Europe have approved a new Phase 3 clinical trial evaluating masitinib, an oral medication, for metastatic castration-resistant prostate cancer (mCRPC). The trial will assess whether masitinib, combined with the chemotherapy drug docetaxel, can delay cancer progression and extend overall survival. Enrolling 600 patients across multiple global centers, participants will be randomized to receive either masitinib plus docetaxel or docetaxel with a placebo. Eligibility requires alkaline phosphatase (ALP) levels of 250 IU/L or lower, a biomarker indicating less advanced metastatic disease, which increases the likelihood of masitinib’s benefit. Previous Phase 3 trial data (AB12003) showed a 21% improvement in progression-free survival for patients with ALP ≤ 250 IU/L, and a 47% reduced risk of progression for those with ALP ≤ 100 IU/L. Masitinib targets immune cells contributing to cancer growth, offering a novel therapeutic approach. If successful, this trial could lead to the first targeted therapy approved with docetaxel for mCRPC in nearly two decades.
• Metformin’s Impact on Prostate Cancer and Metabolic Health
  A recent review inThe Lancet summarized findings from theSTAMPEDE trial, which investigated metformin’s effects in 1,874 non-diabetic patients with metastatic hormone-sensitive prostate cancer (mHSPC). Conducted over a median follow-up of 60 months, the trial examined metformin’s addition to standard treatments like androgen deprivation therapy (ADT).While metformin did not improve overall survival or cancer-specific survival outcomes, it significantly enhanced metabolic health. Patients receiving metformin experienced less weight gain, lower fasting glucose levels, reduced total and LDL cholesterol, decreased glycated hemoglobin (HbA1c), and smaller waist measurements after 104 weeks compared to those on standard care alone. These benefits are particularly relevant, as ADT often causes adverse effects like reduced insulin sensitivity and increased cardiovascular risk. Despite limitations in co-treatment types and patient population, these metabolic improvements suggest metformin’s potential to enhance quality of life and cardiometabolic health, especially given the high contribution of non-cancer causes to mortality in long-term mHSPC survivors.

Preclinical Research

• Novel Targeted Chemotherapy Platform for Precision Oncology​
  A groundbreaking drug delivery platform has been developed to advance precision oncology by delivering chemotherapy drugs directly to tumors while protecting healthy tissues. This innovative system uses a dual-action mechanism to concentrate potent chemotherapy agents at tumor sites and neutralize any free drug molecules that escape, thereby preventing systemic toxicity commonly associated with traditional chemotherapy. In-vitro studies have demonstrated promising results, showing a potential tenfold enhancement of therapeutic effects while maintaining safety for healthy cells. The platform is highly versatile, designed to work with over 100 existing chemotherapy drugs, including generic agents and compounds previously considered too toxic for widespread use. It achieves tumor-selective release by activating drugs only under specific tumor conditions, ensuring concentrated anti-cancer activity. Escaped drug molecules are trapped, rendered inert, and can even be recirculated back to the tumor for re-release, offering additional protection for healthy tissues.
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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