Using alpha radiation therapy before surgery for prostate cancer
A Feasibility of Neoadjuvant Interstitial Brachytherapy (Ibt) Using Diffusing Alpha Emitters Radiation Therapy (Dart) Seeds in Men With Prostate Cancer
This study is testing whether using special radiation seeds to target prostate cancer tumors before surgery can be safe and effective for men with the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Alpha Tau Medical LTD. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 3 sites (Haifa and 2 other locations) |
| Trial ID | NCT04543903 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and safety of using intratumoral diffusing alpha radiation emitter (DaRT) seeds as a neo-adjuvant therapy in men with prostate adenocarcinoma. It is a prospective, open-label, single-center trial where patients with confirmed prostate cancer will receive DaRT seeds to target their tumors before surgical intervention. The study aims to assess the successful delivery of these seeds and the objective response rate through imaging and pathology evaluations.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with pathologically confirmed, resectable prostate adenocarcinoma that is amenable to treatment with DaRT seeds.
Not a fit: Patients with non-resectable prostate cancer or those with significant comorbidities that prevent them from undergoing surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option that enhances tumor control prior to surgery for prostate cancer patients.
How similar studies have performed: While the use of alpha radiation in cancer treatment is an emerging field, this specific approach with DaRT seeds is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed, previously untreated, resectable prostate adenocarcinoma * Ability to provide tissue sample from the target or its vicinity, either from an archive or undergo another biopsy to provide a fresh sample * Medically fit for surgery * Targetable lesion must be technically amenable for complete coverage (including 3-5mm margins) by the DaRT seeds * Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 OR by multiparametric MRI according RECIST v1.1 * Patients must be willing to undergo imaging before and after treatment with DaRT (prior to surgery) * Lesion size ≤ 3 cm in the longest diameter * Age ≥ 18 years old * ECOG Performance Status Scale ≤ 1 * Subjects' life expectancy is more than 6 months * WBC ≥ 3500/μl, granulocyte ≥ 1500/μl * Platelet count ≥ 100,000/μl * Calculated or measured creatinine clearance ≥ 60 cc/min * AST and ALT ≤ 2.5 X ULN * INR \<1.4 for patients not on Warfarin * Subjects are willing and able to sign an informed consent form Exclusion Criteria: * Documented evidence of distant metastases * Prior TURP or prostate surgery * Prior pelvic radiation * Any prior pelvic malignancy or other malignancy in the last 5 years, except for cured non-melanoma skin cancer * Inability to undergo MRI (i.e. permanent implanted device incompatible with MRI) * Known hypersensitivity to any of the components of the treatment. * 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. * Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints. * Patients must 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 implant procedure * 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
Where this trial is running
Haifa and 2 other locations
- RAMBAM Health Care Campus — Haifa, Israel (Recruiting)
- Carmel Medical Center — Haifa, Israel (Recruiting)
- Tel Aviv Medical Center — Tel Aviv, Israel (Not_yet_recruiting)
Study contacts
- Principal investigator: Tomer Charas, M.D — Radiotherapy unit at Rambam Health Care Campus, Israel
- Study coordinator: Ester Deutsch
- Email: EsterD@alphatau.com
- Phone: +972-2-3737-212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.