NCT07208240RecruitingPhase 1/2
Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.
Tb-PSMA-I&T Radionuclide Neo-Adjuvant Treatment in Patients With Locally Advanced Prostate Cancer Before Radical Prostatectomy: TbeforePROST Trial.
Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 12 Aug 2025
- Start date
- 12 Aug 2025
- Primary completion date
- 12 Aug 2028
- Lead sponsor
- Rabin Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT07208240
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 12 Aug 2025 to the primary completion date, 12 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- usage of nephrotoxic drugs
Other illness
- distant metastatic disease
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beilinson Hospital Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.