NCT07208240 Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.
| NCT ID | NCT07208240 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Rabin Medical Center |
| Condition | High Risk Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2028-08-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-08-12 with a primary completion date of 2028-08-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Shay Golan, MD
PRINCIPAL INVESTIGATOR
Rabin Medical Center
Frequently Asked Questions
Who can join the NCT07208240 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying High Risk Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07208240 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07208240 currently recruiting?
Yes, NCT07208240 is actively recruiting participants. Contact the research team at Shaygo1@gmail.com for enrollment information.
Where is the NCT07208240 trial being conducted?
This trial is being conducted at Petah Tikva, Israel.
Who is sponsoring the NCT07208240 clinical trial?
NCT07208240 is sponsored by Rabin Medical Center. The principal investigator is Shay Golan, MD at Rabin Medical Center. The trial plans to enroll 20 participants.
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