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New treatment option for Non-metastatic Prostate Cancer
Official title Alpha Radiation Emitters Device (DaRT) for the Treatment of Non-Metastatic Locally Recurrent Prostate Cancer.
ClinicalTrials.gov ID: NCT06202248
What this study is testing
- What it's testing
- This is a multi-center clinical study enrolling up to 10 participants. The purpose of this study is to assess the feasibility and safety of intratumoral DaRT seeds implantation for the treatment of locally recurrent prostate cancer.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120, men only
You may be able to join if
- Histologically confirmed locally recurrent prostate adenocarcinoma cancer confined to at least 1 hemi-gland with concordant pathology and imaging...
- 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
You likely can't join if
- 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)
See the full eligibility 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
- people' 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...
- Platelet count ≥100,000/mm3
- people are willing and able to sign an informed consent form.
- 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 treatment 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)
- people 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.)
The study team makes the final eligibility decision.
Where it's taking place
- Haifa, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haifa, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.