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

Prostate Cancer Clinical Trial

— NALuPROST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297410
• Other study ID #: 0315-19
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: April 20, 2022

Study information

• Verified date: March 2020
• Source: Rabin Medical Center
• Contact: Shay Golan
• Phone: +7239376554
• Email: Shaygo1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: April 20, 2022
• Est. primary completion date: November 20, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Beilinson hospital	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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