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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427864
• Other study ID #: GULHANEUROCANSICIMLI001
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: March 5, 2023

Study information

• Verified date: June 2022
• Source: Gulhane Training and Research Hospital
• Contact: Can Sicimli, M.D.
• Phone: +905077287879
• Email: cansicimli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: March 5, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Cancer Stage
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Multiparametric Prostate MRI
Comparison of Ga68 PSMA PET and Multiparametric Prostate MR imaging tests used in staging in patients diagnosed with prostate cancer

Locations

Country	Name	City	State
Turkey	Gulhane Research and Training Hospital	Ankara	Etlik

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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