Comparison of Multiparametric Prostate MRI and Ga-68 PSMA PET Imaging in Prostate Cancer Staging

June 25, 2022 updated by: Can Sicimli, Gulhane Training and Research Hospital

In this study, it is aimed to compare the lesion location, lesion size, local and distant metastases detection rates of Ga68 PSMA PET and Multiparametric Prostate MR imaging tests used in staging in patients diagnosed with prostate cancer.

The pathologies of the patients who were decided to undergo radical prostatectomy as a treatment will also be compared with the staging tests.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Etlik
      • Ankara, Etlik, Turkey, 06010
        • Recruiting
        • Gülhane Research and Training Hospital
        • Contact:
        • Principal Investigator:
          • Can Sicimli, M.D.
        • Sub-Investigator:
          • Selahattin Bedir, Prof.
        • Sub-Investigator:
          • Kemal Niyazi Arda, Prof.
        • Sub-Investigator:
          • Hatice Tuba Sanal, Prof.
        • Sub-Investigator:
          • Alev Çınar, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • diagnosed with prostate cancer
  • Gleason score 7 or above / 6 with high risk
  • No other treatment

Exclusion Criteria:

  • treated with radiotherapy
  • treated with ADT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion location
Time Frame: Between prostate biopsy and curative treatment decision , usually 2 month
Both MRI and PET results will be compared. Lesion location will be defined as "left", "right", "apical", "basal", "midline".
Between prostate biopsy and curative treatment decision , usually 2 month
Lesion Size
Time Frame: Between prostate biopsy and curative treatment decision , usually 2 month
Both MRI and PET results will be compared, Lesion size will be stated in milimeters.
Between prostate biopsy and curative treatment decision , usually 2 month
Lymph node involvement
Time Frame: Between prostate biopsy and curative treatment decision , usually 2 month
Both MRI and PET results will be compared. Involvement will be stated as "exist", "non-exist".
Between prostate biopsy and curative treatment decision , usually 2 month
Extraprostatic involvement
Time Frame: Between prostate biopsy and curative treatment decision , usually 2 month
Both MRI and PET results will be compared. Involvement will be stated as "exist" , "non-exist".
Between prostate biopsy and curative treatment decision , usually 2 month
Local and distant metastasis
Time Frame: Between prostate biopsy and curative treatment decision , usually 2 month
Both MRI and PET results will be compared. Metastasis will be stated as "exist" , "non-exist".
Between prostate biopsy and curative treatment decision , usually 2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulhane Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

January 5, 2023

Study Completion (Anticipated)

March 5, 2023

Study Registration Dates

First Submitted

June 11, 2022

First Submitted That Met QC Criteria

June 19, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 25, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GULHANEUROCANSICIMLI001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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