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

Clalit Health Services

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: High Risk Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07208240

RMC 833-23

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patients receiving Tb-PSMA before RAdical prostatectomy

Experimental group

Description:

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

Treatment:

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