Tb-PSMA radionuclide treatment before radical prostatectomy for locally advanced prostate cancer
Tb-PSMA-I&T Radionuclide Neo-Adjuvant Treatment in Patients With Locally Advanced Prostate Cancer Before Radical Prostatectomy: TbeforePROST Trial.
This will try giving a Tb-PSMA radionuclide treatment to men with high-risk, locally advanced prostate cancer before prostate removal to see if it is safe and reduces tumor burden.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 1 site (Petah Tikva) |
| Trial ID | NCT07208240 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 or older with high-risk localized prostate cancer (cT3/4 and/or Gleason score ≥8 and/or PSA ≥20 ng/mL), confirmed high PSMA expression, ECOG 0–1, life expectancy >10 years, and acceptable blood counts and kidney function.
Not a fit: Patients with distant metastatic disease, low PSMA expression, poor blood counts, low albumin, reduced kidney function, or current use of nephrotoxic drugs are excluded and unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could reduce tumor burden before surgery and lower the risk of residual disease or recurrence.
How similar studies have performed: Tb-PSMA radionuclide treatments have shown promising early results in metastatic prostate cancer, but using Tb-PSMA before prostate removal for locally advanced disease is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Petah Tikva
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.