Tb-PSMA-I&T Radionuclide Before Radical Prostatectomy in Patients With Locally Advanced Prostate Cancer - TbeforePROST Trial.

NCT07208240 | Recruiting Phase 1 DMC

• 1 other identifier: RMC 833-23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

High Risk Prostate Cancer

Keywords

High risk Prostate cancer; Radical Prostatectomy; PSMA; Theranostics; radionuclide therapy

Outcome Measures

Primary Outcomes (2)

• Number of Tb-PSMA adverse effects measured by CTCAE v4.0 and number of surgical complications - measured by the Clavien-Dindo Classification (2009)

  1 year

• Surgical and clinical safety

  The primary outcome is the safety of administering Tb-PSMA before radical prostatectomy, its impact on intra- and post-operative clinical course according to the Clavien-Dindo Classification.

  1 year

Secondary Outcomes (1)

• Immediate oncological outcomes as measured by number of patients with positive surgical margins and number of patients who achieved biochemical complete response

  3 months

Study Arms (1)

Patients receiving Tb-PSMA before RAdical prostatectomy

EXPERIMENTAL

Patients with high-risk locally advanced prostate cancer will receive 3 Tb-161-PSMA treatments followed by radical prostatectomy.

Drug: Tb-PSMA-I&T (Tb-PSMA)

Interventions

Tb-PSMA-I&T (Tb-PSMA) DRUG

Terbium-161 produce beta emission with the addition of Auger electrons which have higher linear energy transfer and a very short range. By that it has the potential to improve local and distal (micro-metastatic disease) efficacy with a similar safety profile. It will be given to patients with high risk locally advanced prostate cancer prior to Radical prostatectomy

Also known as: radical prostatectomy

Patients receiving Tb-PSMA before RAdical prostatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Beilinson Hospital

Petah Tikva, Israel

RECRUITING

Study Officials

• Shay Golan, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shay Golan, MD

CONTACT

+972507447573; Shaygo1@gmail.com

Hana Burnstein, MD

CONTACT

+972544400822; hanna@erezcom.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro Shay Golan , Chair of Urology at Rabin Medical Cener

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: October 6, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): August 12, 2028
• Study Completion (Estimated): August 12, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

IL (1)