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NCT Number: NCT07208240

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

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.

Recruiting

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Key information

Conditions

High Risk Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Tb-PSMA-I&T (Tb-PSMA)

Drug

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

Other names: radical prostatectomy

Primary outcomes

  1. 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

  2. Surgical and clinical safety

    Time frame: 1 year

    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.

Secondary outcomes

  1. Immediate oncological outcomes as measured by number of patients with positive surgical margins and number of patients who achieved biochemical complete response

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hana Burnstein, MD

CONTACT

[email protected]

+972544400822

Shay Golan, MD

CONTACT

[email protected]

+972507447573

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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