A Phase 1/2 interventional study of Tb-PSMA-I&T (Tb-PSMA) in High Risk Prostate Cancer, sponsored by Rabin Medical Center. Recruiting at 1 site in Israel. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Rabin Medical Center · Phase 1/2, Interventional, and Treatment
This is a multi-disciplinary collaboration between urologists, oncologists and nuclear medicine physicians from Beilinson hospital at Rabin Medical Center to address the major therapeutic challenge of locally advanced prostate cancer. Our aim is to evaluate the use of a novel treatment (Tb-PSMA) prior to the surgical removal of the prostate. This treatment has already shown initial promising results in patients with metastatic prostate cancer but has never been tested for locally advanced disease before surgery.
Exclusion Criteria:
Patients with high-risk locally advanced prostate cancer will receive 3 Tb-161-PSMA treatments followed by radical prostatectomy.
Drug: Tb-PSMA-I&T (Tb-PSMA)
Terbium-161 produce beta emission with the addition of Auger electrons which have higher linear energy transfer and a very short range. By that it has the potential to improve local and distal (micro-metastatic disease) efficacy with a similar safety profile. It will be given to patients with high risk locally advanced prostate cancer prior to Radical prostatectomy
Also known as: radical prostatectomy
Number of Tb-PSMA adverse effects measured by CTCAE v4.0 and number of surgical complications - measured by the Clavien-Dindo Classification (2009)
Time frame: 1 year
Surgical and clinical safety
The primary outcome is the safety of administering Tb-PSMA before radical prostatectomy, its impact on intra- and post-operative clinical course according to the Clavien-Dindo Classification.
Time frame: 1 year
Immediate oncological outcomes as measured by number of patients with positive surgical margins and number of patients who achieved biochemical complete response
Secondary outcomes include the immediate response to treatment in terms of biochemical response. A post-surgical prostate specific antigen above 0.1 ng/ml is considered biochemical failure.
Time frame: 3 months
Plan to share: Undecided
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Rabin Medical Center