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

Primary Purpose

Prostate Cancer, Prostate Cancer Stage

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Multiparametric Prostate MRI

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Gulhane Research and Training HospitalRecruiting

Outcomes

Primary Outcome Measures

Lesion location

Both MRI and PET results will be compared. Lesion location will be defined as "left", "right", "apical", "basal", "midline".

Lesion Size

Both MRI and PET results will be compared, Lesion size will be stated in milimeters.

Lymph node involvement

Both MRI and PET results will be compared. Involvement will be stated as "exist", "non-exist".

Extraprostatic involvement

Both MRI and PET results will be compared. Involvement will be stated as "exist" , "non-exist".

Local and distant metastasis

Both MRI and PET results will be compared. Metastasis will be stated as "exist" , "non-exist".

Secondary Outcome Measures

Full Information

NCT ID

NCT05427864

First Posted

June 11, 2022

Last Updated

June 25, 2022

Sponsor

Gulhane Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05427864

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

January 5, 2023 (Anticipated)

Study Completion Date

March 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gulhane Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Prostate Cancer Stage

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

47 male patients who will be evaluated with both imaging studies will be included in the study.

Masking

None (Open Label)

Allocation

N/A

Enrollment

47 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Diagnostic Test

Intervention Name(s)

Multiparametric Prostate MRI

Other Intervention Name(s)

Ga-68 PSMA PET

Intervention Description

Comparison of Ga68 PSMA PET and Multiparametric Prostate MR imaging tests used in staging in patients diagnosed with prostate cancer

Primary Outcome Measure Information:

Title

Lesion location

Description

Both MRI and PET results will be compared. Lesion location will be defined as "left", "right", "apical", "basal", "midline".

Time Frame

Between prostate biopsy and curative treatment decision , usually 2 month

Title

Lesion Size

Description

Both MRI and PET results will be compared, Lesion size will be stated in milimeters.

Time Frame

Between prostate biopsy and curative treatment decision , usually 2 month

Title

Lymph node involvement

Description

Both MRI and PET results will be compared. Involvement will be stated as "exist", "non-exist".

Time Frame

Between prostate biopsy and curative treatment decision , usually 2 month

Title

Extraprostatic involvement

Description

Both MRI and PET results will be compared. Involvement will be stated as "exist" , "non-exist".

Time Frame

Between prostate biopsy and curative treatment decision , usually 2 month

Title

Local and distant metastasis

Description

Both MRI and PET results will be compared. Metastasis will be stated as "exist" , "non-exist".

Time Frame

Between prostate biopsy and curative treatment decision , usually 2 month

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Because of prostate cancer study

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Can Sicimli, M.D.

Phone

+905077287879

cansicimli@gmail.com

Facility Information:

Facility Name

Gulhane Research and Training Hospital

City

Ankara

State/Province

Etlik

ZIP/Postal Code

06010

Country

Turkey

Individual Site Status

Recruiting

Facility Contact: