Clinical trial NCT04297410: 177Lu-PSMA-I&T Prior to Radical Prostatectomy for Locally Advanced Disease
Official title: 177Lu-PSMA-I&T Radionuclide Neo-Adjuvant Treatment in Patients With Locally Advanced Prostate Cancer Prior to Radical Prostatectomy: Feasibility Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

  3. 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.

  4. 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).

Primary outcomes:
measure: Surgical safety
timeFrame: 2 years
measure: Early oncological outcomes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Beilinson hospital
Study officials:
References: