TheranosticTrials.org

Clinical Trial · NCT04297410

177Lu-PSMA-I&T Prior to Radical Prostatectomy for Locally Advanced Disease

Overview

Despite surgical advances, up to 50% of patients with high-risk locally advanced prostate cancer will die from their disease. Drug therapy before surgery has the potential to improve treatment success by lowering tumor volume in the prostate and treating small metastases. PET PSMA is an advanced imaging technique that allows the identification of areas involved by the tumor in the prostate or in the pelvis. This technique is based on the protein PSMA (prostate-specific membrane antigen) which is located on the tumor cells. The presence of PSMA on tumor cells has been recently used for treatment purposes. A chemical element (Lutetium) that binds to PSMA and emits local radiation can destroy tumors cells. This treatment has been used in patients with advanced metastatic disease and showed promising results. The investigators hypothesized that using these particles can improve long term results in patients who undergo surgery for prostate cancer which has not extensively spread. The investigators will assess both the immediate and long-term impact of this novel treatment.

Sponsor

Asan Medical Center

Phase

N/A

Contacts

Shay Golan (CONTACT)

shaygo1@gmail.com

+7239376554

David Groshar (CONTACT)

davidgr2@clalit.org.il

+97239375668

ClinicalTrials.gov

NCT04297410

Drug / Compound

PSMA-I&T

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTAGA

Eligibility

Inclusion

Inclusion criteria not yet provided.

Exclusion

  • 1\. Clinically significant impaired bone marrow defined by platelet count lower than 150×103/µl, white blood cells count lower than 4×103/µl, hemoglobin concentration lower than 12mg/dl. 2\. Impaired liver function defined by albumin concentration lower than 3.5 gr/dl. 3\. Impaired kidney function defined by glomerular filtration rate (GFR) lower than 40 mL/min. 4\. Recent radiotherapy (within two months) 5. Concomitant usage of nephrotoxic drugs 6. Evidence of distant metastatic disease (distal lymphadenopathy, visceral or bone metastases).