The Value of PSMA-PET Compared With Multi-parametric MRI in the Detection Prostate Lesions

NCT03174054 | Unknown

• 1 other identifier: 0132-16
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prostate cancer is a common disease in men. In prostate 35% of biopsies, usually done due to increased PSA levels or clinical suspicion, are false negative, despite malignancy. Multi-parametric prostate MRI detects malignant neoplasm lesions better than other imaging devices. A sonar-guided prostate biopsy based on multi-parametric MRI images improves detection of malignancy. Ga68 PSMA-PET test uses a radioactive marker that binds to the prostate's cells and is shown to be a primary prostate tumor site in addition to metastasis. We believe that the combination of measures from a single Ga68 PSMA and multi-parametric MRI test can lead to further improvement in malignancy, better biopsy guidance, and optimal treatment for the patient.

Conditions

Prostate Cancer

Keywords

Men aged 40 and over; multi parametric MRI

Outcome Measures

Primary Outcomes (1)

• correlation between SUV to PSA levels.

  PET Measurements vs. clinical measurements

  24 months in relation to each patient baseline

Study Arms (3)

Patients with no clear lesion in PET or MRI

If the clinical suspicion of cancer is low, there will be no biopsy, only follow-up. If the decision is to perform a biopsy on the prostate, it will be performed with transrectal sonar guidance and systematic biopsies will be performed (12 samples will be taken from different areas of the prostate)

Patients with MRI lesions and overlapping mapping lesions

If MRI and PET are matched, a US FUSION MRI biopsy will be taken between 4-8 samples directly from the lesion as well as other systemic prostate samples according to the surgeon's decision. Will be taken and sent separately to pathology.

Procedure: Biopsy

Patients with a discrepancy between the PET and MRI

A FUSION approach will be biopsy. Four to eight samples for each lesion, as well as other systemic prostate samples will be taken according to the surgeon's decision, and the samples will be marked and sent separately to the pathology.

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

Biopsies are part of standard procedures in the patients recruited and will not be done due to this study.

Patients with MRI lesions and overlapping mapping lesions; Patients with a discrepancy between the PET and MRI

Eligibility Criteria

• Age: 40 Years - 95 Years
• Gender Eligibility Details: Men with suspected prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men aged 40 and over,with clinical suspicion of prostate cancer, referred for multi parametric MRI .

You may qualify if:

• Men aged 40 and over.
• Patients with clinical suspicion of prostate cancer, referred for multi parametric MRI

You may not qualify if:

• Are unable to perform multi-parameter MRI (eg GFR below 30, metals in the body, claustrophobia, etc.).
• Can not / want to sign informed consent form.

Sponsors & Collaborators

• Assuta Medical Center: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• David Groshar, MD

  Head of nuclear medicine unit in Assuta Medical Centers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Groshar, MD

CONTACT

+972-37645497; davidg@assuta.co.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: June 2, 2017
• Study Start: June 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share