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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Israel
Beilinson Hospital
RECRUITING
Petah Tikva
Contact Information
Primary
Shay Golan, MD
Shaygo1@gmail.com
+972507447573
Backup
Hana Burnstein, MD
hanna@erezcom.net
+972544400822
Time Frame
Start Date: 2025-08-12
Estimated Completion Date: 2028-08-12
Participants
Target number of participants: 20
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Rabin Medical Center

This content was sourced from clinicaltrials.gov