Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.
Recruiting · NCT07208240 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Tb-PSMA-I&T (Tb-PSMA)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Beilinson Hospital - Petah Tikva, Israel