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Darolutamide Shows Promising Results in Treating Metastatic Hormone-Sensitive Prostate Cancer

The ARASENS trial highlights the efficacy of darolutamide combined with androgen-deprivation therapy and docetaxel, showing a significant reduction in the risk of death for patients with metastatic hormone-sensitive prostate cancer.

In the realm of prostate cancer treatment, serum tumor markers play a pivotal role, especially prostate-specific antigen (PSA), which is highly sensitive and specific post-definitive local therapy. It can detect micrometastatic disease well before any radiographic or symptomatic evidence of disease, guiding curative-intent salvage therapies like salvage radiation upon biochemical recurrence (BCR).
A significant breakthrough comes from the ARASENS trial (NCT02799602), where darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel demonstrated a 32.5% reduction in the risk of death (HR, 0.68; 95% CI, 0.57-0.80; P < .0001) compared to placebo plus ADT with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). This trial underscores the potential of darolutamide as a formidable option in the treatment landscape for mHSPC, offering new hope for patients battling this aggressive form of prostate cancer.
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The FDA has accepted a supplemental new drug application (sNDA) for darolutamide in combination with androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (HSPC).
The sNDA is supported by the phase 3 ARANOTE trial, which demonstrated a significant reduction in the risk of disease progression or death with darolutamide plus ADT compared to placebo plus ADT.

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UpFrontPSMA Trial: Lutetium-PSMA Plus Docetaxel Shows Promise in Metastatic Hormone-Sensitive Prostate Cancer

The UpFrontPSMA trial demonstrated that adding lutetium-PSMA to docetaxel significantly improved undetectable PSA rates at 48 weeks in mHSPC patients.
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ARANOTE Trial: Darolutamide Plus ADT Significantly Reduces Risk in Metastatic Hormone-Sensitive Prostate Cancer

The Phase 3 ARANOTE trial demonstrated that darolutamide plus androgen-deprivation therapy (ADT) significantly reduces the risk of radiological progression or death in men with metastatic hormone-sensitive prostate cancer (mHSPC).
According to Dr. Fred Saad, the findings suggest that darolutamide plus ADT could become a new standard of care, adding to existing ARPI options for mHSPC treatment.

ARANOTE Trial: Darolutamide Plus ADT Improves Outcomes in Metastatic Hormone-Sensitive Prostate Cancer

The ARANOTE trial demonstrated that darolutamide plus androgen deprivation therapy (ADT) significantly improves radiographic progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Darolutamide-treated patients experienced a 46% reduction in the risk of radiographic progression or death compared to those receiving ADT plus placebo, with consistent benefits across subgroups.

Darolutamide Plus ADT Shows Promise in Metastatic Hormone-Sensitive Prostate Cancer

Darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46% in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The ARANOTE trial data supports the expanded use of darolutamide in mHSPC patients, both with and without docetaxel, according to Bayer.

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Darolutamide Demonstrates Efficacy in Chinese Patients with Metastatic Hormone-Sensitive Prostate Cancer

Darolutamide, combined with androgen deprivation therapy (ADT) and docetaxel, shows favorable efficacy and safety in Chinese patients with metastatic hormone-sensitive prostate cancer (mHSPC).
A subpopulation analysis of the ARASENS trial reveals a 36% reduction in the risk of death with darolutamide compared to placebo in Chinese patients with mHSPC.

Reference News

[1]
UroToday - The Global Online Community of Urologists
urotoday.review · Feb 23, 2024

Serum tumor markers like PSA are crucial for detecting prostate cancer recurrence early, enabling curative treatments. T...

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