NCT04297410

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

177Lu-PSMA-I&T Radionuclide Neo-Adjuvant Treatment in Patients With Locally Advanced Prostate Cancer Prior to Radical Prostatectomy: Feasibility Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-20
• Primary completion: 2021-11-20
• Completion: 2022-04-20
• First posted: 2020-03-05
• Last updated: 2020-03-05

Locations

1 site across 1 country: Israel