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

NCT ID: NCT04297410

Last Updated: 2020-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2022-04-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant LuPSMA

Group Type: EXPERIMENTAL

177Lu-PSMA-I&T Radionuclide

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

golan shay

Director of urologic-oncology service, Principal Investigator, Clinical senior lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rabin Medical Center, Beilinson hospital

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Shay Golan

Role: CONTACT

Shaygo1@gmail.com

+7239376554

David Groshar

Role: CONTACT

DavidGr2@clalit.org.il

+97239375668

Facility Contacts

Shay Golan

Role: primary

Shaygo1@gmail.com

+97239376554

Other Identifiers

0315-19

Identifier Type: -

Identifier Source: org_study_id