NCT05427864

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
47

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2023

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

3 years

First QC Date

June 11, 2022

Last Update Submit

June 25, 2022

Conditions

Prostate CancerProstate Cancer Stage

Outcome Measures

Primary Outcomes (5)

  • Lesion location

    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

    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

    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

    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

    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

Interventions

Multiparametric Prostate MRIDIAGNOSTIC_TEST

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

Also known as: Ga-68 PSMA PET

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBecause of prostate cancer study
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • treated with radiotherapy
  • treated with ADT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Research and Training Hospital

Ankara, Etlik, 06010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Can Sicimli, M.D.

CONTACT

+905077287879cansicimli@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 47 male patients who will be evaluated with both imaging studies will be included in the study.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2022

First Posted

June 22, 2022

Study Start

January 1, 2020

Primary Completion

January 5, 2023

Study Completion

March 5, 2023

Last Updated

June 28, 2022

Record last verified: 2022-06

Locations

TU(1)