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

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Radiation: 177Lu-PSMA-I&T Radionuclide

• Registration Number: NCT04297410
• Lead Sponsor: Rabin Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-20
• Study First Submitted: 2019-11-25
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-03
• Last Update Submitted: 2020-03-03
• Study First Posted: 2020-03-05
• Last Update Posted: 2020-03-05
• Primary Completion: 2021-11-20
• Study Completion: 2022-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 5

Inclusion Criteria

• 1. Male aged 18 years and older. 2. Patients were diagnosed with high risk localized prostate cancer (cT3/4 and/or Gleason score ≥8 and/or prostate biopsy or PSA ≥ 20 ng/dl) or loco-regional prostate cancer (pelvic lymphadenopathy of ≥2 cm on axial imaging).

  2. High PSMA expression was confirmed. PET PSMA with tracer uptake greater than normal liver (maximal standardized uptake value ≥1.5 of liver). In addition, no PET FDG positive sites without high PSMA expression.

  3. Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status score5 of 1 or lower and life expectancy of > 10 years.

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant LuPSMA	177Lu-PSMA-I&T Radionuclide	-

Primary Outcome Measures

Name	Time	Method
Surgical safety	2 years	Surgical safety will be assessed according to the rate of intra- and post operative complications graded according to the clavien dindo classification.
Early oncological outcomes	2 years	Early oncological outcomes will be assessed according to the final surgical histology (e.g. stage , grade) and postoperative PSA

Trial Locations

Locations (1)

Rabin Medical Center, Beilinson hospital; 🇮🇱 Petach Tikva, Israel