Back to results177Lu-PSMA-I&T Prior to Radical Prostatectomy for Locally Advanced Disease (NALuPROST)
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
177Lu-PSMA-I&T Radionuclide
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
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).
Sites / Locations
- Rabin Medical Center, Beilinson hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neoadjuvant LuPSMA
Arm Description
Outcomes
Primary Outcome Measures
Surgical safety
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
Early oncological outcomes will be assessed according to the final surgical histology (e.g. stage , grade) and postoperative PSA
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04297410
Brief Title
177Lu-PSMA-I&T Prior to Radical Prostatectomy for Locally Advanced Disease
Acronym
NALuPROST
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
November 20, 2021 (Anticipated)
Study Completion Date
April 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neoadjuvant LuPSMA
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
177Lu-PSMA-I&T Radionuclide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Surgical safety
Description
Surgical safety will be assessed according to the rate of intra- and post operative complications graded according to the clavien dindo classification.
Time Frame
2 years
Title
Early oncological outcomes
Description
Early oncological outcomes will be assessed according to the final surgical histology (e.g. stage , grade) and postoperative PSA
Time Frame
2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shay Golan
Phone
+7239376554
Email
Shaygo1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
David Groshar
Phone
+97239375668
Email
DavidGr2@clalit.org.il
Facility Information:
Facility Name
Rabin Medical Center, Beilinson hospital
City
Petach Tikva
ZIP/Postal Code
4941494
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shay Golan
Phone
+97239376554
Email
Shaygo1@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
177Lu-PSMA-I&T Prior to Radical Prostatectomy for Locally Advanced Disease
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