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

Last updated: March 3, 2020
Sponsor: Rabin Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

N/A

Clinical Study ID

NCT04297410
0315-19
  • Ages > 18
  • Male

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

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

Exclusion

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 concentrationlower than 12mg/dl.

  1. Impaired liver function defined by albumin concentration lower than 3.5 gr/dl.

  2. Impaired kidney function defined by glomerular filtration rate (GFR) lower than 40mL/min.

  3. Recent radiotherapy (within two months) 5. Concomitant usage of nephrotoxic drugs

  4. Evidence of distant metastatic disease (distal lymphadenopathy, visceral or bonemetastases).

Study Design

Total Participants: 5
Study Start date:
November 20, 2019
Estimated Completion Date:
April 20, 2022

Connect with a study center

  • Rabin Medical Center, Beilinson hospital

    Petach Tikva, 4941494
    Israel

    Active - Recruiting

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