Treatment of Locally Recurrent Prostate Cancer

NCT07290998 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CTP-PRST-05
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center clinical study enrolling up to 12 participants . The primary objective of the study is to evaluate the safety of Alpha DaRT for the treatment of locally recurrent prostate cancer . The secondary objectives of the study is to evaluate the efficacy of the Alpha DaRT sources in locally recurrent prostate cancer patients assessed by biochemical and clinical evaluation of disease progression as well as overall survival

Conditions

Prostate Cancer; Recurrent Prostate Cancer; Locally Recurrent Prostate Cancer

Keywords

Alpha radiation; Prostate Cancer; Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Safety -Serious adverse events

  The primary safety endpoint is the overall incidence of device related serious adverse events (SAEs) over the duration of the trial

  From Day 0, Up to 3 years

Secondary Outcomes (5)

• To evaluate the efficacy of DaRT seeds according to blood tests

  12 month study, 2 years follow up ±1 month every 6 months.

• To evaluate the efficacy DaRT seeds according to Overall survival

  once every 6 months for 2 years after final follow-up visit at 12 months

• To evaluate the efficacy of DaRT seeds according to Life Questionnaire- QLQ- PR25

  at day 0, 30 , 12 months and once every 6 months for 2 years

• To evaluate the efficacy of DaRT seeds according to Life Questionnaire-IPSS

  at day 0, 30 , 12 months and once every 6 months for 2 years

• To evaluate the efficacy of DaRT seeds according to Life Questionnaire-SHIM

  at day 0, 30 , 12 months and once every 6 months for 2 years

Other Outcomes (2)

• To evaluate the efficacy of DaRT seeds according to clinical evaluation measured by Physical Examination and ECOG Performance status.

  up to 3 years

• To evaluate the efficacy of DaRT seeds according to Disease progression measured by MRI / PSMA PET

  Up to 3 years

Study Arms (1)

DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Interventions

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) DEVICE

An intratumoral insertion of radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms

DaRT Seeds

Eligibility Criteria

• Age: 40 Years - 120 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically and/or cytologically proven prostate adenocarcinoma
• Biochemical recurrence by the Phoenix definition (PSA nadir + 2 ng/mL) and confirmed by a pre-treatment biopsy.
• Patients eligible for focal salvage brachytherapy
• Clinical stage T1-T2 on relapse; unilateral extracapsular extension (T3a) on MRI permitted except posteriorly relative to the rectum
• Pre-salvage PSA level (rPSA) \< 10 ng/ml
• Target lesion is technically amenable for Alpha DaRT sources implantation.
• Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 OR by multiparametric MRI according RECIST v1.1 (Patients who were classified as stage II according to MRI)
• Lesion size ≤ 5 cm in the longest diameter
• ECOG Performance Status Scale 0 - 2
• Life expectancy is more than 6 months
• WBC ≥ 3500/µl, granulocyte ≥ 1500/µl
• Platelet count ≥60,000/µl
• Creatinine ≤1.9 mg/dL
• AST and ALT ≤ 2.5 X upper limit of normal (ULN)
• INR \< 1.4 for patients not on Warfarin

You may not qualify if:

• Concomitant immunotherapy within the past 4 weeks.
• Patients with lymph node or metastatic disease
• Known hypersensitivity to any of the components of the treatment.
• Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
• Patients with prior surgery or low-dose-rate (LDR) brachytherapy as the primary treatment of their prostate cancer.
• \[For Stage 1 of the study only\] Patients with prior high-dose-rate (HDR) brachytherapy or stereotactic body radiation therapy (SBRT) as the primary treatment of their prostate cancer.
• Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
• Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.
• Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
• Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation, and for 3 months after DaRT insertion
• 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).

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Liron Dimnik

CONTACT

0542688602; LironD@alphatau.com

Aviya Hoida

CONTACT

972-547869466; aviyah@alphatau.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 18, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share