MedTrace Logo

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

NCT04297410 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-03-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

177Lu-PSMA-I&T Radionuclide

Each patient will receive two single doses of 7.4 GBq 177-Lu-PSMA-I\&T treatments. The treatments will be given intravenously, 2 weeks apart starting 12 weeks prior to radical prostatectomy.

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2021-11-20
Completion
2022-04-20

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04297410 on ClinicalTrials.gov