Treatment of recurrent prostate cancer using Alpha DaRT seeds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to evaluate the feasibility and safety of using Alpha DaRT seeds for treating men with non-metastatic locally recurrent prostate cancer. It involves the implantation of radioactive seeds directly into the tumor, with the primary goal of assessing the successful placement of these seeds through imaging techniques. Additionally, the study will measure the impact of this treatment on patients' quality of life. The study is designed as a multicenter, single-arm, open-label intervention with up to 10 participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed locally recurrent prostate adenocarcinoma cancer confined to at least 1 hemi-gland with concordant pathology and imaging findings within 6 months prior to consenting
* Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 or by multiparametric MRI according RECIST v1.1
* Patient being considered for focal salvage brachytherapy
* Lesion size ≤ 3 cm in the longest diameter
* Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds
* Pre-salvage PSA level (rPSA) below \<10 ng/ml
* Age ≥ 18 years old
* ECOG Performance Status Scale ≤ 2
* Subjects' life expectancy is more than 6 months
* Negative metastatic workup on at least standard imaging (CT CAP and bone scan). Other metastatic screening studies allowed in lieu of standard imaging including multiparametric MRI prostate/whole body, PSMA PET, F18 PET or Axumin PET within 3 months before visit 0
* Platelet count ≥100,000/mm3
* Subjects are willing and able to sign an informed consent form.

Exclusion Criteria:

* N1 or M1 disease
* Prior TURP or prostate surgery
* Inability to undergo multiparametric MRI (i.e. permanent implanted device incompatible with MRI)
* Inability to undergo general or spinal anesthesia
* Prior androgen deprivation therapy or systemic chemotherapy for prostate cancer within 3 months before visit 0.
* Previous diagnosis of other malignancy \< 3 years of enrollment (excluding non-melanomatous skin cancer)
* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT
* High probability of protocol non-compliance (in opinion of investigator)
* Subjects not willing to sign an informed consent
* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)

Where it's running

• RAMBAM Health Care Campus
  Haifa, Israel Recruiting

Study contacts

• Principal investigator: Tomer Charas, MD — Radiotherapy unit at Rambam Health Care Campus, Israel
• Study coordinator: Liron Dimnik
• Email: LironD@alphatau.com
• Phone: +972542688602

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This trial tests different ways of giving radiation therapy to see which balance best controls the cancer with the fewest side effects in men with high-risk, non-metastatic prostate cancer.

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• Focal radiotherapy for men with recurrent prostate cancer

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  Recruiting Royal North Shore Hospital · St Leonards, New South Wales · NCT03073278

• Alpha-emitting seed treatment for recurrent glioblastoma

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  Recruiting at 3 sites Alpha Tau Medical LTD. · Scottsdale, Arizona and 2 other locations · NCT06910306

• Alpha DaRT for Locally Advanced Pancreatic Cancer test

  This trial tests inserting Alpha DaRT sources into a locally advanced pancreatic tumor to see if it can become resectable.

  Recruiting Alpha Tau Medical LTD. · Bordeaux and 11 other locations · NCT06755359

• Alpha DaRT treatment for skin squamous cell cancer in immunocompromised patients

  This study tests whether placing Alpha DaRT seeds directly into a skin squamous cell carcinoma can shrink tumors and improve outcomes in people with compromised immune systems.

  Recruiting at 6 sites Alpha Tau Medical LTD. · Gilbert, Arizona and 10 other locations · NCT06615635

• Treatment of Breast Cancer with Alpha Radiation in Elderly or Frail Patients

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  Recruiting Alpha Tau Medical LTD. · Jerusalem · NCT06202118

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.