A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device as a neo-adjuvant therapy in men with prostate cancer
The study is planned as a prospective, open-label, one arm, single center trial, designed to assess the feasibility and safety of intratumoral DaRT seeds implantation for the treatment of local prostate cancer prior to surgery. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. Prostate lesions with histopathological confirmation of adenocarcinoma will be treated using DaRT seeds in a neo-adjuvant setting. Feasibility will be assessed by the successful delivery of DaRT seeds into the intratumoral environment. In addition, objective response rate will be assessed both by imaging and pathology.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
RAMBAM Health Care Campus
Haifa, Israel
Carmel Medical Center
Haifa, Israel
Tel Aviv Medical Center
Tel Aviv, Israel
Feasibility of intratumoral DaRT seeds implantation
To evaluate the feasibility of intratumoral insertion of DaRT seeds into prostate adenocarcinoma in the neoadjuvant setting. Feasibility will defined as the successful delivery of DaRT.
Time frame: Study visit 'Day 0'
Safety of intratumoral DaRT seeds implantation
To evaluate the safety of intratumoral insertion of DaRT seeds into prostate adenocarcinoma in the neoadjuvant setting. To evaluate the safety of intratumoral insertion of DaRT seeds into prostate adenocarcinoma in the neoadjuvant setting by the frequency and severity of acute adverse events related to DaRT. Adverse events will be assessed and graded according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.
Time frame: Study visit 'Day 0'
Pathological ORR
To asses the percentage of patients whose cancer shrinks or disappears after treatment using a biopsy from removed prostate.
Time frame: Week 4-6
Radiological ORR
Radiological response rate according to PSMA-PET/ multiparametric MRI (SUV change/T2 weighting) through comparison with baseline imaging as assessed by RECIST or PERCIST.
Time frame: 1 Week prior to surgery
Change in quality of life
Change in disease related QoL using the EPIC questionnaires from baseline to prior to surgery
Time frame: Screening. Day 22.
Change in quality of life
Change in disease related QoL using the IPSS questionnaires from baseline to prior to surgery
Time frame: Screening. Day 22.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.