Using PSMA PET-CT as a Diagnostic Tool for Detection of Prostatic Cancer at an Early Stage

NCT04116086 | Unknown DMC

• 1 other identifier: SHEBA-19-6243-TD-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is the evaluation of the possible role of PSMA PET-CT in early detection of prostate cancer, reducing rate of unnecessary prostate biopsies, and in cases of prostate cancer, correct staging of the disease and corresponding management.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Prostate Cancer Diagnosis

  One investigator will interpret the PSMA PET-CT and another one will interpret MRI, both in a blinded and independent fashion and before the biopsy. At the end of the study, these 'blind' PSMA PET-CT and MRI reports will be compared to each other and to the actual fusion biopsy results. In the event that a high correlation is found between the diagnostic imaging results to those of the fusion biopsies, it would suggest that PSMA PET-CT could give the option to be performed instead of the need for biopsy in men who present with high levels of PSA and prompt treatment accordingly.

  2 months

Study Arms (1)

PSMA PET-CT exam

OTHER

Ga 68 -PSMA PET/CT scanning will be performed using a combined PET/CT protocol with a 16-detector-row helical CT scanner (Philips Gemini GXL). This scanner allows simultaneous acquisition of up to 45 transaxial PET images with interslice spacing of 5 mm in one bed position and provides an image from the vertex to the thigh in about 10 bed positions. The use of (68)Ga-PSMA HBED-CC results in a relatively low radiation exposure, delivering organ doses that are comparable to those of other (68)Ga-labelled PSMA-inhibitors used for PET-imaging. Total effective dose is lower than for other PET-agents used for prostate cancer imaging (e.g. (11) C- and (18) F-Choline).

Diagnostic Test: Prostate Biopsy Test

Interventions

Prostate Biopsy Test DIAGNOSTIC_TEST

see earlier information

Also known as: PSMA PET-CT Imaging

PSMA PET-CT exam

Eligibility Criteria

• Age: 40 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 40-75
• With or without suspicious DRE,
• Were referred by their treating physicians for prostate cancer biopsy based on either an elevated PSA result, a suspicious DRE exam, or both
• \< PSA ≤ 10 ng/ml

You may not qualify if:

• A previous diagnosis of prostate cancer
• Underwent previous prostate biopsy
• Previous radiation to pelvis for any reason

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5265601, 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

Tima Davidson, Dr.

CONTACT

972-52-6666677; Tima.Davidson@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Hybrid Imaging Unit

Model Details: One investigator will interpret the PSMA PET-CT and another one will interpret MRI, both in a blinded and independent fashion and before the biopsy. At the end of the study, these 'blind' PSMA PET-CT and MRI reports will be compared to each other and to the actual fusion biopsy results. In the event that a high correlation is found between the diagnostic imaging results to those of the fusion biopsies, it would suggest that PSMA PET-CT could give the option to be performed instead of the need for biopsy in men who present with high levels of PSA and prompt treatment accordingly.

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: October 4, 2019
• Study Start: September 11, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)