Treatment of recurrent prostate cancer using Alpha DaRT seeds

A Feasibility and Safety Study of Focal Interstitial Radiotherapy Using Diffusing Alpha Emitters Radiation Therapy (DaRT) Seeds in Men With Non-metastatic Locally Recurrent Prostate Cancer.

This study is testing if placing radioactive seeds directly into tumors can safely treat men with recurring prostate cancer and improve their quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 120 Years
• Sex: Male
• Sponsor: Alpha Tau Medical LTD. (industry)
• Drugs / interventions: chemotherapy, Radiation
• Locations: 1 site (Haifa)
• Trial ID: NCT06202248 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 18 and older with histologically confirmed locally recurrent prostate adenocarcinoma that is targetable and meets specific imaging criteria.

Not a fit: Patients with metastatic prostate cancer or those whose lesions exceed the size limit for treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel and effective option for men with locally recurrent prostate cancer, potentially improving their quality of life.

How similar studies have performed: While this approach using Alpha DaRT seeds is relatively novel, similar studies involving localized radiation therapies have shown promising results in treating recurrent cancers.

Eligibility criteria

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 this trial is running

Haifa

• 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

Conditions: Non-metastatic Prostate Cancer, Locally Recurrent Prostate Cancer, recurrent prostate cancer., Alpha emitting radiation, Alpha DaRT, Prostate cancer