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

NCT04297410 | Unknown DMC

• 1 other identifier: 0315-19
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Early oncological outcomes

  Early oncological outcomes will be assessed according to the final surgical histology (e.g. stage , grade) and postoperative PSA

  2 years

Study Arms (1)

Neoadjuvant LuPSMA

EXPERIMENTAL

Radiation: 177Lu-PSMA-I&T Radionuclide

Interventions

177Lu-PSMA-I&T Radionuclide RADIATION

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.

Neoadjuvant LuPSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.
• \. Impaired liver function defined by albumin concentration lower than 3.5 gr/dl.
• \. Impaired kidney function defined by glomerular filtration rate (GFR) lower than 40 mL/min.
• \. Recent radiotherapy (within two months) 5. Concomitant usage of nephrotoxic drugs 6. Evidence of distant metastatic disease (distal lymphadenopathy, visceral or bone metastases).

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center, Beilinson hospital

Petah Tikva, 4941494, Israel

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Shay Golan

CONTACT

+7239376554; Shaygo1@gmail.com

David Groshar

CONTACT

+97239375668; DavidGr2@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of urologic-oncology service, Principal Investigator, Clinical senior lecturer

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: March 5, 2020
• Study Start: November 20, 2019
• Primary Completion: November 20, 2021
• Study Completion: April 20, 2022
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)