Prostate CancerNCT05427864
Comparison of Multiparametric Prostate MRI and Ga-68 PSMA PET Imaging in Prostate Cancer Staging
A study testing Multiparametric Prostate MRI in people with Prostate Cancer and Prostate Cancer Stage, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Stage
- What is being tested?
- Multiparametric Prostate MRI
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 5 Mar 2023
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed with prostate cancer
- Gleason score 7 or above / 6 with high risk
- No other treatment
Who cannot join
- treated with radiotherapy
- treated with ADT
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gulhane Research and Training Hospital
Ankara, Etlik, 06010
Can Sicimli, M.D., +905077287879, cansicimli@gmail.com
Can Sicimli, M.D.
About this study
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.
- Conditions
- Prostate Cancer, Prostate Cancer Stage
- Being tested
- Multiparametric Prostate MRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric Prostate MRIDiagnostic test
Also called Ga-68 PSMA PET
Comparison of Ga68 PSMA PET and Multiparametric Prostate MR imaging tests used in staging in patients diagnosed with prostate cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion location
Both MRI and PET results will be compared. Lesion location will be defined as "left", "right", "apical", "basal", "midline".
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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".
Measured: Between prostate biopsy and curative treatment decision , usually 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Jan 2020
- Primary completion5 Jan 2023 (estimated)
- Study completion5 Mar 2023 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 47 male patients who will be evaluated with both imaging studies will be included in the study.
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Can Sicimli, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427864
- Sponsor's protocol ID
- GULHANEUROCANSICIMLI001
- Status last verified
- Jun 2022
- First submitted
- 11 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Multiparametric Prostate MRI and Ga-68 PSMA PET Imaging in Prostate Cancer Staging
- ClinicalTrials.gov ID
- NCT05427864
- Acronym / sponsor ID
- GULHANEUROCANSICIMLI001
- Conditions
- Prostate Cancer, Prostate Cancer Stage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 5 Jan 2023 (estimated)
- Study completion
- 5 Mar 2023 (estimated)
- First posted
- 22 Jun 2022 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- 47 male patients who will be evaluated with both imaging studies will be included in the study.
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with prostate cancer
- Gleason score 7 or above / 6 with high risk
- No other treatment
Key exclusion criteria (2 listed)
- treated with radiotherapy
- treated with ADT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric Prostate MRIAlso: Ga-68 PSMA PETComparison of Ga68 PSMA PET and Multiparametric Prostate MR imaging tests used in staging in patients diagnosed with prostate cancer | Diagnostic test | – |
Primary outcome
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".
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.
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".
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".
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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiparametric Prostate MRI in people with Prostate Cancer and Prostate Cancer Stage, run by Gulhane 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Can Sicimli, M.D. (+905077287879, cansicimli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion location (time frame: Between prostate biopsy and curative treatment decision , usually 2 month). The study lists 5 primary outcomes in all. 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 28 Jun 2022.