Tb-PSMA-I&T Radionuclide Neo-Adjuvant Treatment in Patients With Locally Advanced Prostate Cancer Before Radical Prostatectomy: TbeforePROST Trial.
Sponsor study identifier
interventional
20
1 country
1
Study Start
August 12, 2025
Actual (reported)Primary Completion
August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 12, 2025
Actual (reported)August 12, 2025
Actual (reported)October 6, 2025
Actual (reported)August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of Tb-PSMA adverse effects measured by CTCAE v4.0 and number of surgical complications - measured by the Clavien-Dindo Classification (2009)
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.
1 year
Immediate oncological outcomes as measured by number of patients with positive surgical margins and number of patients who achieved biochemical complete response
3 months
Patients with high-risk locally advanced prostate cancer will receive 3 Tb-161-PSMA treatments followed by radical prostatectomy.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Beilinson Hospital
Petah Tikva, Israel
Shay Golan, MD
Rabin Medical Center
First Submitted
August 12, 2025
First Posted
October 6, 2025
Study Start
August 12, 2025
Actual (reported)Primary Completion
August 12, 2028
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 6, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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