Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 135

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 135
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 the Alpha DaRT treatment and then under prostate removal surgery 50 days later.

The primary objective of the
study is to evaluate the feasibility and the safety of intratumoral insertion of Alpha DaRT sources into prostate adenocarcinoma in the
neoadjuvant setting. The secondary objectives are to evaluate the pathological ORR at 35 days (+/-7) following Alpha DaRT source insertion
through the examination of the pathology of the tumor after prostatectomy, the radiological ORR based on imaging (change in standard uptake
value and T2 weighting) within one week before surgery and the change in disease-related QoL. The exploratory objectives are to assess
DNA damage and repair and immune infiltration (biomarker analysis: CD34, TILs) from baseline to surgery and within one week of surgery,
and the biochemical response evaluation based on PSA levels. The first patient in this trial was treated in June 2022 and demonstrated
a partial response to treatment.

Rambam Health Care Campus,
Israel (recruiting)

We have also initiated a second
clinical trial at the Rambam Health Care Campus in Israel, to examine the use of Alpha DaRT for focal treatment of recurrent prostate
cancer tumors. The trial will recruit up to 10 patients with recurrent, non-metastatic prostate adenocarcinoma. The primary objective
of the study is to evaluate the feasibility and the safety of intratumoral insertion of Alpha DaRT sources into prostate adenocarcinoma.
The secondary objectives include evaluation of efficacy using biochemical and radiological response, as well as patient-reported quality
of life measures. The first patient in this trial was treated in May 2024.

Liver Metastases

The liver is the most common
site for metastatic disease from the gastrointestinal tract. It is also one of the most commons sites for metastases of other malignancies
such as breast cancer, lung cancer, and melanoma. In colorectal cancer, about two thirds of 600,000 annual deaths are related to liver
metastases. Liver metastases are diagnosed in more than 50% of colorectal cancer patients during the course of their disease. During the
last two decades, treatment paradigms of metastatic disease have changed dramatically. While surgical resection of metastases was once
considered futile, today surgical resection of liver metastases is a well-established therapeutic strategy and offers the best chance
for long term survival for suitable patients. Colorectal