Tb-PSMA radionuclide treatment before radical prostatectomy for locally advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2, multidisciplinary trial gives Tb-PSMA-I&T radionuclide therapy to men with high-risk, locally advanced prostate cancer prior to planned radical prostatectomy. Participants must have high PSMA expression on imaging and meet predefined blood, kidney, and performance-status criteria, while patients with distant metastases or significant organ dysfunction are excluded. The trial aims to characterize safety, tolerability, and feasibility of preoperative Tb-PSMA and to look for early signals of tumor response at surgery and on imaging. Tb-PSMA has shown promising initial results in metastatic disease but has not been tested as a neoadjuvant approach before prostate removal.

Why it matters

Who can join: the full rules

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

Where it's running

• Beilinson Hospital
  Petah Tikva, Israel Recruiting

Study contacts

• Principal investigator: Shay Golan, MD — Rabin Medical Center
• Study coordinator: Shay Golan, MD
• Email: Shaygo1@gmail.com
• Phone: +972507447573

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Repeated PSMA PET scans to monitor treatment response in clinically significant prostate cancer.

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• Comparing Lutetium-177 and Actinium-225 PSMA-targeted radiation before prostatectomy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.