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

NCT ID: NCT07208240

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2028-08-12

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients receiving Tb-PSMA before RAdical prostatectomy

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

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

Intervention Type: DRUG

Other Intervention Names

radical prostatectomy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

golan shay

Pro Shay Golan , Chair of Urology at Rabin Medical Cener

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shay Golan, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Beilinson Hospital

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Shay Golan, MD

Role: CONTACT

Shaygo1@gmail.com

+972507447573

Hana Burnstein, MD

Role: CONTACT

hanna@erezcom.net

+972544400822

Facility Contacts

Shay Golan, MD

Role: primary

Shayg@clalit.org.il

+97239376559

Other Identifiers

RMC 833-23

Identifier Type: -

Identifier Source: org_study_id