Prostate CancerPSMA-MRI BXNCT07533344
Ga-68 PSMA PET/CT vs mpMRI in Cognitive Prostate Biopsy
An observational study of Prostate Cancer, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Prostate cancer is the most common malignancy among elderly men. With the routine use of prostate-specific antigen (PSA) testing since the 1980s, the incidence of prostate cancer has significantly increased. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥40 years who underwent cognitive prostate biopsy for suspected prostate cancer with pre-biopsy imaging using multiparametric prostate MRI or Ga-68 PSMA PET/CT between 2020 and 2024.
Who may be able to join
- Male patients aged 40 years or older
- Patients who underwent cognitive prostate biopsy between 2020 and 2024
- Patients who had pre-biopsy imaging with multiparametric prostate MRI or Ga-68 PSMA PET/CT
- Patients with available prostate biopsy pathology results
- Patients with prostate lesions scored PIRADS 4 or 5 on multiparametric prostate MRI
Who cannot join
- Patients with incomplete clinical or imaging data
- Patients without available histopathological biopsy results
- Patients who underwent prostate biopsy without pre-biopsy imaging
- Patients with lesions scored PIRADS ≤3 on multiparametric prostate MRI
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Istanbul, 34752
About this study
Official title: Comparison of Ga-68 PSMA PET/CT and Multiparametric Prostate MRI for Lesion Detection in Cognitive Prostate Biopsy
Prostate cancer is the most common malignancy among elderly men. With the routine use of prostate-specific antigen (PSA) testing since the 1980s, the incidence of prostate cancer has significantly increased. The diagnosis of prostate cancer is established through prostate biopsy, and several biopsy techniques have been developed in recent years.
Prostate biopsy can be broadly classified into systematic and targeted biopsy techniques. Systematic biopsy is performed under transrectal or transperineal ultrasound guidance without the use of prior imaging. Targeted biopsy techniques include cognitive biopsy, multiparametric magnetic resonance imaging (mpMRI) fusion biopsy, in-bore MRI biopsy, and robotic biopsy.
Read more
Cognitive biopsy is defined as the targeting of lesions identified on pre-biopsy imaging, usually multiparametric prostate MRI. MRI-fusion biopsy integrates mpMRI images with real-time ultrasound images, while in-bore biopsy is performed directly under MRI guidance. Although MRI-fusion biopsy is considered the gold standard technique, cognitive biopsy is more commonly used in developing countries due to lower cost and reasonable diagnostic accuracy.
Recently, Ga-68 prostate-specific membrane antigen (PSMA) PET/CT has become the gold standard imaging modality for staging prostate cancer after receiving FDA approval. PSMA is a type II transmembrane protein highly expressed on prostate cancer cells. PSMA PET/CT has high sensitivity and specificity for the detection, staging, and recurrence of prostate cancer.
Currently, multiparametric prostate MRI is commonly used to detect lesions before cognitive biopsy. However, there is no study in the literature evaluating the use of PSMA PET/CT imaging for guiding cognitive prostate biopsy.
In this retrospective single-center study, the investigators aim to compare the effectiveness of Ga-68 PSMA PET/CT and multiparametric prostate MRI as imaging modalities used prior to cognitive prostate biopsy.
Read the detailed description
This retrospective study will include patients who underwent cognitive prostate biopsy at the Urology Department of Health Sciences University Fatih Sultan Mehmet Training and Research Hospital between 2020 and 2024.
Patient records will be reviewed retrospectively. The collected data will include:
Age PSA levels PSA density Prostate volume Prostate biopsy pathology results mpMRI PIRADS scores Ga-68 PSMA PET/CT imaging reports
Patients will be divided into two groups according to the imaging modality used prior to cognitive prostate biopsy:
Patients evaluated with multiparametric prostate MRI Patients evaluated with Ga-68 PSMA PET/CT
The diagnostic outcomes of cognitive biopsy will be compared between these two imaging modalities.
Since the study is retrospective, it will not require additional procedures, interventions, or costs for patients or the institution.
The study will be conducted at a single center.
- Conditions
- Prostate Cancer
- Keywords
- Prostate biopsy, Ga-68 PSMA PET/CT, Multiparametric MRI, Cognitive biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mpMRI-guided Cognitive Biopsy | Patients who underwent cognitive prostate biopsy after lesion detection with multiparametric prostate MRI. | |
| Ga-68 PSMA PET/CT-guided Cognitive Biopsy | Patients who underwent cognitive prostate biopsy after lesion detection with Ga-68 PSMA PET/CT imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically Significant Prostate Cancer Detection Rate
Comparison of clinically significant prostate cancer detection rates between patients undergoing cognitive prostate biopsy guided by multiparametric prostate MRI and those guided by Ga-68 PSMA PET/CT.
Measured: Periprocedural (at the time of prostate biopsy)
Secondary outcomes (1)
Superiority of Ga-68 PSMA PET/CT-guided cognitive biopsy over mpMRI-guided biopsy in detecting prostate cance
Comparison of prostate cancer detection rates
Measured: Periprocedural (at the time of prostate biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Aug 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serkan Akan, MD, Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533344
- Sponsor's protocol ID
- FSMTRHURO
- Acronym
- PSMA-MRI BX
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ga-68 PSMA PET/CT and Multiparametric Prostate MRI for Lesion Detection in Cognitive Prostate Biopsy
- ClinicalTrials.gov ID
- NCT07533344
- Acronym / sponsor ID
- PSMA-MRI BX / FSMTRHURO
- Conditions
- Prostate Cancer
- Keywords
- Prostate biopsy, Ga-68 PSMA PET/CT, Multiparametric MRI, Cognitive biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate cancer is the most common malignancy among elderly men. With the routine use of prostate-specific antigen (PSA) testing since the 1980s, the incidence of prostate cancer has significantly increased. The diagnosis of prostate cancer is established through prostate biopsy, and several biopsy techniques have been developed in recent years.
Prostate biopsy can be broadly classified into systematic and targeted biopsy techniques. Systematic biopsy is performed under transrectal or transperineal ultrasound guidance without the use of prior imaging. Targeted biopsy techniques include cognitive biopsy, multiparametric magnetic resonance imaging (mpMRI) fusion biopsy, in-bore MRI biopsy, and robotic biopsy.
Cognitive biopsy is defined as the targeting of lesions identified on pre-biopsy imaging, usually multiparametric prostate MRI. MRI-fusion biopsy integrates mpMRI images with real-time ultrasound images, while in-bore biopsy is performed directly under MRI guidance. Although MRI-fusion biopsy is considered the gold standard technique, cognitive biopsy is more commonly used in developing countries due to lower cost and reasonable diagnostic accuracy.
Recently, Ga-68 prostate-specific membrane antigen (PSMA) PET/CT has become the gold standard imaging modality for staging prostate cancer after receiving FDA approval. PSMA is a type II transmembrane protein highly expressed on prostate cancer cells. PSMA PET/CT has high sensitivity and specificity for the detection, staging, and recurrence of prostate cancer.
Currently, multiparametric prostate MRI is commonly used to detect lesions before cognitive biopsy. However, there is no study in the literature evaluating the use of PSMA PET/CT imaging for guiding cognitive prostate biopsy.
In this retrospective single-center study, the investigators aim to compare the effectiveness of Ga-68 PSMA PET/CT and multiparametric prostate MRI as imaging modalities used prior to cognitive prostate biopsy.
Detailed description
This retrospective study will include patients who underwent cognitive prostate biopsy at the Urology Department of Health Sciences University Fatih Sultan Mehmet Training and Research Hospital between 2020 and 2024.
Patient records will be reviewed retrospectively. The collected data will include:
Age PSA levels PSA density Prostate volume Prostate biopsy pathology results mpMRI PIRADS scores Ga-68 PSMA PET/CT imaging reports
Patients will be divided into two groups according to the imaging modality used prior to cognitive prostate biopsy:
Patients evaluated with multiparametric prostate MRI Patients evaluated with Ga-68 PSMA PET/CT
The diagnostic outcomes of cognitive biopsy will be compared between these two imaging modalities.
Since the study is retrospective, it will not require additional procedures, interventions, or costs for patients or the institution.
The study will be conducted at a single center.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mpMRI-guided Cognitive Biopsy | – | –Patients who underwent cognitive prostate biopsy after lesion detection with multiparametric prostate MRI. |
| Ga-68 PSMA PET/CT-guided Cognitive Biopsy | – | –Patients who underwent cognitive prostate biopsy after lesion detection with Ga-68 PSMA PET/CT imaging. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥40 years who underwent cognitive prostate biopsy for suspected prostate cancer with pre-biopsy imaging using multiparametric prostate MRI or Ga-68 PSMA PET/CT between 2020 and 2024.
Key inclusion criteria (5 listed)
- Male patients aged 40 years or older
- Patients who underwent cognitive prostate biopsy between 2020 and 2024
- Patients who had pre-biopsy imaging with multiparametric prostate MRI or Ga-68 PSMA PET/CT
- Patients with available prostate biopsy pathology results
- Patients with prostate lesions scored PIRADS 4 or 5 on multiparametric prostate MRI
Key exclusion criteria (4 listed)
- Patients with incomplete clinical or imaging data
- Patients without available histopathological biopsy results
- Patients who underwent prostate biopsy without pre-biopsy imaging
- Patients with lesions scored PIRADS ≤3 on multiparametric prostate MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinically Significant Prostate Cancer Detection Rate
Time frame: Periprocedural (at the time of prostate biopsy)
Comparison of clinically significant prostate cancer detection rates between patients undergoing cognitive prostate biopsy guided by multiparametric prostate MRI and those guided by Ga-68 PSMA PET/CT.
1 secondary outcome
Superiority of Ga-68 PSMA PET/CT-guided cognitive biopsy over mpMRI-guided biopsy in detecting prostate cance
Time frame: Periprocedural (at the time of prostate biopsy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serkan Akan, MD principal investigator
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Significant Prostate Cancer Detection Rate (time frame: Periprocedural (at the time of prostate biopsy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.