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Clinical Trial NCT07208240 for High Risk Prostate Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial. Phase 1, Phase 2 20 Novel Treatment

Recruiting
Clinical Trial NCT07208240 is designed to study Treatment for High Risk Prostate Cancer. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 12 August 2025, with plans to enroll 20 participants. Led by Rabin Medical Center, it is expected to complete by 12 August 2028. The latest data from ClinicalTrials.gov was last updated on 6 October 2025.
Brief Summary
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 ...Show More
Official Title

Tb-PSMA-I&T Radionuclide Neo-Adjuvant Treatment in Patients With Locally Advanced Prostate Cancer Before Radical Prostatectomy: TbeforePROST Trial.

Conditions
High Risk Prostate Cancer
Other Study IDs
  • RMC 833-23
NCT ID Number
NCT07208240
Start Date (Actual)
2025-08-12
Last Update Posted
2025-10-06
Completion Date (Estimated)
2028-08-12
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Recruiting
Keywords
High risk Prostate cancer
Radical Prostatectomy
PSMA
Theranostics
radionuclide therapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPatients receiving Tb-PSMA before RAdical prostatectomy
Patients with high-risk locally advanced prostate cancer will receive 3 Tb-161-PSMA treatments followed by radical prostatectomy.
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
3 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
  • Male aged 18 years and older.
  • Patients with high-risk localized prostate cancer (cT3/4 and/or Gleason score ≥ eight and/or prostate biopsy or PSA ≥ 20 ng/dl)
  • High PSMA expression was confirmed according to PROMISE V2 8
  • Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or lower and a life expectancy of > 10 years.

  • Platelet count lower than 150×103/µl
  • white blood cell count lower than 4×103/µl,
  • haemoglobin concentration lower than 12mg/dl.
  • albumin concentration lower than 3.5 g/dl.
  • glomerular filtration rate (GFR) lower than 40 mL/min.
  • usage of nephrotoxic drugs
  • distant metastatic disease
Rabin Medical Center logoRabin Medical Center
Study Responsible Party
golan shay, Principal Investigator, Pro Shay Golan , Chair of Urology at Rabin Medical Cener, Rabin Medical Center
Study Central Contact
Contact: Shay Golan, MD, +972507447573, [email protected]
Contact: Hana Burnstein, MD, +972544400822, [email protected]
1 Study Locations in 1 Countries
Beilinson Hospital, Petah Tikva, Israel
Shay Golan, MD, Contact, +97239376559, [email protected]
Recruiting