Low Risk Prostate CancerI-SELECTNCT07168616
Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance
An observational study of Low Risk Prostate Cancer and Clinically Significant Prostate Cancer, run by Istanbul University - Cerrahpasa at 10 sites in Turkey (Türkiye).
Trial summary
This is a multicenter, prospective diagnostic accuracy study evaluating the Istanbul PSMA PET/CT Criteria (IPPC) for selecting patients with biopsy-confirmed low-risk prostate cancer (ISUP Grade 1) for active surveillance (AS). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Low Risk Prostate Cancer, Clinically Significant Prostate Cancer
- What is being tested?
- Ga-68 PSMA11 PET/CT
- How many people
- 201 participants
- Where
- 10 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Jun 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Only Turkish patients
Who may be able to join
- mpMRI performed within 3 months prior to enrollment
- Systematic or MRI-targeted prostate biopsy performed
- Biopsy-confirmed ISUP Grade 1 low-risk PCa
- Prostate biopsy report specifying tumor localization and number of positive cores
- Meets AS criteria: ISUP 1, PSA ≤10 ng/mL, PSAd >0.15 ng/mL², clinical stage cT1c-T2a, ≤3 positive cores
- Life expectancy ≥10 years
Show all 9Show fewer
- No prior PSMA PET imaging
- No evidence of extra-prostatic disease on mpMRI
- Signed informed consent for study procedures
Who cannot join
- High-risk or unfavorable intermediate-risk PCa, or adverse histologies (neuroendocrine, ductal adenocarcinoma, basal cell carcinoma, TP53 or BRCA1/2 mutations if available)
- Prior prostate cancer treatment or prostate surgery
- MRI evidence of extracapsular extension, seminal vesicle invasion, or nodal metastasis
- History of pelvic radiotherapy
- Life expectancy <10 years
- Severe renal impairment
- Inability to comply with follow-up schedule
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Turkey (Türkiye)10 sites, 10 recruiting
- Recruiting
Bilkent Şehir Hastanesi
Ankara
Elif Cingi Ozdemir, Prof. MD., 00905326841880, ozdemire80@gmail.com
Asım Özayar, Prof. MD
- Recruiting
Gazi Yaşargil Egitim ve Arastirma Hastanesi
Diyarbakır
Halil Komek, Prof. MD., 00905064767778, email:halilkomek@gmail.com
- Recruiting
Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama hastanesi
Gaziantep
Umut Elboga, Prof. MD., 00905355164132, umutelboga@hotmail.com
Mehmet Ozturk, Asc. Prof. MD., 00905393328554, mehmetozturk000@gmail.com
- Recruiting
Yeditepe University
Istanbul, Turkey, 34000
Nalan Alan, Prof. MD., 00905322940667, nalanselcuk@yahoo.com
Kaan Akcay, Resident, MD, 00905079195680, Kaan.akcay@yeditepe.edu.tr
- Recruiting
Acibadem University Altunizade Hospital
Istanbul, 34000
Levent Turkeri, Prof. MD., 00905333572898, levent.turkeri@acibadem.edu.tr
- Recruiting
Acibadem University Maslak Hospital
Istanbul, 34000
Ali Rıza Kural, Prof. MD., 00905323139626, arkural@gmail.com
Mustafa Bilal Tuna, Asc. Prof. MD., 00905052532047, mustafabilalturna@gmail.com
- Recruiting
Haseki Eğitim ve Araştırma Hastanesi
Istanbul, 34000
Rüştü Turkay, Prof. MD., 00905322008672, rustuturrkay@hotmail.com
Ezgi Gursoy, Radiologist MD, 00905054669151, drezgigursoy@gmail.com
- Recruiting
Istanbul University-Cerrahpaşa
Istanbul, 34000
Levent Kabasakal, Prof. MD., 00905323667908, lkabasakal@tsnm.org
Onur Erdem Sahin, Asc. Prof. MD., 00905557041806, onur.sahin@iuc.edu.tr
- Recruiting
SBÜ Başakşehir Çam Sakura Şehir hastanesi
Istanbul, 34000
Burcu Esen Akkaş, Prof. MD., 00905327450364, burcuesen@yahoo.com
Halil Lütfi Canat, Prof. MD., 00905056884234, drclcanat@gmail.com
- Recruiting
Sisli Hamidiye Etfal Eğitim ve Arastırma Hastanesi
Istanbul, 34000
Nurettin Cem Sonmez, Prof. MD., 00905324259128, ncsonmez@hotmail.com
About this study
Official title: Prospective Evaluation of Istanbul PSMA PET/CT Criteria for Selecting Candidates for Active Surveillance in Low-Risk Prostate Cancer
This is a multicenter, prospective diagnostic accuracy study evaluating the Istanbul PSMA PET/CT Criteria (IPPC) for selecting patients with biopsy-confirmed low-risk prostate cancer (ISUP Grade 1) for active surveillance (AS). The study integrates delayed Ga-68 PSMA PET/CT imaging into the diagnostic pathway to refine patient stratification, minimize overtreatment and potentially reduce unnecessary biopsies and MRI, or exposing high-risk individuals to the danger of cancer progression if left untreated scans.
Read the detailed description
Prostate cancer is the most common malignancy in men and demonstrates heterogeneous clinical behavior. While many low-risk patients have indolent disease, a subset harbors clinically significant prostate cancer (csPCa) requiring early intervention. Active Surveillance (AS) is widely used to avoid overtreatment; however, current selection criteria-PSA, DRE, biopsy Gleason score, number of positive cores, PSA density, and mpMRI-lack sufficient predictive accuracy. Studies indicate that up to 30% of patients classified as low-risk by biopsy are found to have higher-grade disease at radical prostatectomy. The Istanbul PSMA PET/CT Criteria (IPPC) were developed by a multidisciplinary expert panel in Turkey to classify intraprostatic lesions on delayed (120-minute) Ga-68 PSMA PET/CT imaging into three risk categories:
- IPPC 1 No or homogeneous low uptake - safe for monitoring.
- IPPC 2: Indeterminate uptake - AS with close follow-up.
- IPPC 3: Focal, lentiform, high SUVmax ≥12 uptake in peripheral zone - definitive treatment recommended.
This study will evaluate the diagnostic performance of IPPC compared to standard mpMRI and biopsy findings, using radical prostatectomy pathology or long-term clinical follow-up as the reference standard.
- Being tested
- Ga-68 PSMA11 PET/CT
- Keywords
- PSMA PET/CT, Low risk prostate cancer, active surveillance, prostate cancer, clinically significant prostate cancer, Diagnosis of prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68 PSMA11 PET/CTDiagnostic test
delayed (120-minute) Ga-68 PSMA PET/CT and will be evaluated by using Istanbul PSMA PET/CT Criteria (IPPC)
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Diagnostic Accuracy of the Istanbul PSMA PET/CT Criteria (IPPC) for Detecting Clinically Significant Prostate Cancer (csPCa)
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve (AUC) for IPPC classification in identifying csPCa, defined as ISUP Grade Group ≥2 on radical prostatectomy pathology or disease progression on long-term follow-up.
Measured: Baseline imaging; confirmed at prostatectomy or through 2-year follow-up.
Secondary outcomes (1)
Reduction in Repeat Biopsy Rate
Percentage of patients avoiding unnecessary repeat biopsies due to IPPC classification, compared with historical AS protocols
Measured: Assessed over 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Sep 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Risk Prostate CancerStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 201 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Yeditepe University, Yedikule Training and Research Hospital, Acibadem University, Ankara Yildirim Beyazıt University, University of Gaziantep, Istanbul Training and Research Hospital, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital, Sisli Hamidiye Etfal Training and Research Hospital, Haseki Training and Research Hospital
- Responsible party
- Principal investigator, Levent Kabasakal, Istanbul University - Cerrahpasa
- Investigators
- Levent Kabasakal, Prof. MD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168616
- Sponsor's protocol ID
- 2024-KAEK-21/1153
- Acronym
- I-SELECT
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akcay K, Beydagi G, Sahin OE, Akyel R, Akgun E, Ekmekcioglu O, Alan Selcuk N, Toklu T, Dogan Ekici AI, Kapran K, Kabasakal L. Improved Accuracy and Reliability of PRIMARY Scoring Using Delayed [68Ga] Ga-PSMA PET/CT Imaging. Mol Imaging Radionucl Ther. 2025 Feb 7;34(1):1-9. doi: 10.4274/mirt.galenos.2025.16023.
PubMed 39917984Emmett L, Papa N, Buteau J, Ho B, Liu V, Roberts M, Thompson J, Moon D, Sheehan-Dare G, Alghazo O, Agrawal S, Murphy D, Stricker P, Hope TA, Hofman MS. The PRIMARY Score: Using Intraprostatic 68Ga-PSMA PET/CT Patterns to Optimize Prostate Cancer Diagnosis. J Nucl Med. 2022 Nov;63(11):1644-1650. doi: 10.2967/jnumed.121.263448. Epub 2022 Mar 17.
PubMed 35301240Akcay K, Kibar A, Sahin OE, Demirbilek M, Beydagi G, Asa S, Aghazada F, Toklu T, Selcuk NA, Onal B, Kabasakal L. Prediction of clinically significant prostate cancer by [68 Ga]Ga-PSMA-11 PET/CT: a potential tool for selecting patients for active surveillance. Eur J Nucl Med Mol Imaging. 2024 Apr;51(5):1467-1475. doi: 10.1007/s00259-023-06556-y. Epub 2023 Dec 19.
PubMed 38112777Cornford P, van den Bergh RCN, Briers E, Van den Broeck T, Brunckhorst O, Darraugh J, Eberli D, De Meerleer G, De Santis M, Farolfi A, Gandaglia G, Gillessen S, Grivas N, Henry AM, Lardas M, van Leenders GJLH, Liew M, Linares Espinos E, Oldenburg J, van Oort IM, Oprea-Lager DE, Ploussard G, Roberts MJ, Rouviere O, Schoots IG, Schouten N, Smith EJ, Stranne J, Wiegel T, Willemse PM, Tilki D. EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer-2024 Update. Part I: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2024 Aug;86(2):148-163. doi: 10.1016/j.eururo.2024.03.027. Epub 2024 Apr 13.
PubMed 38614820
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Istanbul PSMA PET/CT Criteria for Selecting Candidates for Active Surveillance in Low-Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT07168616
- Acronym / sponsor ID
- I-SELECT / 2024-KAEK-21/1153
- Keywords
- PSMA PET/CT, Low risk prostate cancer, active surveillance, prostate cancer, clinically significant prostate cancer, Diagnosis of prostate cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Yeditepe University, Yedikule Training and Research Hospital, Acibadem University, Ankara Yildirim Beyazıt University, University of Gaziantep, Istanbul Training and Research Hospital, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital, Sisli Hamidiye Etfal Training and Research Hospital, Haseki Training and Research Hospital
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 11 Sep 2025 (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.
This is a multicenter, prospective diagnostic accuracy study evaluating the Istanbul PSMA PET/CT Criteria (IPPC) for selecting patients with biopsy-confirmed low-risk prostate cancer (ISUP Grade 1) for active surveillance (AS). The study integrates delayed Ga-68 PSMA PET/CT imaging into the diagnostic pathway to refine patient stratification, minimize overtreatment and potentially reduce unnecessary biopsies and MRI, or exposing high-risk individuals to the danger of cancer progression if left untreated scans.
Detailed description
Prostate cancer is the most common malignancy in men and demonstrates heterogeneous clinical behavior. While many low-risk patients have indolent disease, a subset harbors clinically significant prostate cancer (csPCa) requiring early intervention. Active Surveillance (AS) is widely used to avoid overtreatment; however, current selection criteria-PSA, DRE, biopsy Gleason score, number of positive cores, PSA density, and mpMRI-lack sufficient predictive accuracy. Studies indicate that up to 30% of patients classified as low-risk by biopsy are found to have higher-grade disease at radical prostatectomy. The Istanbul PSMA PET/CT Criteria (IPPC) were developed by a multidisciplinary expert panel in Turkey to classify intraprostatic lesions on delayed (120-minute) Ga-68 PSMA PET/CT imaging into three risk categories:
- IPPC 1 No or homogeneous low uptake - safe for monitoring.
- IPPC 2: Indeterminate uptake - AS with close follow-up.
- IPPC 3: Focal, lentiform, high SUVmax ≥12 uptake in peripheral zone - definitive treatment recommended.
This study will evaluate the diagnostic performance of IPPC compared to standard mpMRI and biopsy findings, using radical prostatectomy pathology or long-term clinical follow-up as the reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only Turkish patients
Key inclusion criteria (9 listed)
- mpMRI performed within 3 months prior to enrollment
- Systematic or MRI-targeted prostate biopsy performed
- Biopsy-confirmed ISUP Grade 1 low-risk PCa
- Prostate biopsy report specifying tumor localization and number of positive cores
- Meets AS criteria: ISUP 1, PSA ≤10 ng/mL, PSAd >0.15 ng/mL², clinical stage cT1c-T2a, ≤3 positive cores
Key exclusion criteria (7 listed)
- High-risk or unfavorable intermediate-risk PCa, or adverse histologies (neuroendocrine, ductal adenocarcinoma, basal cell carcinoma, TP53 or BRCA1/2 mutations if available)
- Prior prostate cancer treatment or prostate surgery
- MRI evidence of extracapsular extension, seminal vesicle invasion, or nodal metastasis
- History of pelvic radiotherapy
- Life expectancy <10 years
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 |
|---|---|---|
| Ga-68 PSMA11 PET/CTdelayed (120-minute) Ga-68 PSMA PET/CT and will be evaluated by using Istanbul PSMA PET/CT Criteria (IPPC) | Diagnostic test | – |
Primary outcome
1. Diagnostic Accuracy of the Istanbul PSMA PET/CT Criteria (IPPC) for Detecting Clinically Significant Prostate Cancer (csPCa)
Time frame: Baseline imaging; confirmed at prostatectomy or through 2-year follow-up.
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve (AUC) for IPPC classification in identifying csPCa, defined as ISUP Grade Group ≥2 on radical prostatectomy pathology or disease progression on long-term follow-up.
1 secondary outcome
Reduction in Repeat Biopsy Rate
Time frame: Assessed over 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 39917984Akcay K, Beydagi G, Sahin OE, Akyel R, Akgun E, Ekmekcioglu O, Alan Selcuk N, Toklu T, Dogan Ekici AI, Kapran K, Kabasakal L. Improved Accuracy and Reliability of PRIMARY Scoring Using Delayed [68Ga] Ga-PSMA PET/CT Imaging. Mol Imaging Radionucl Ther. 2025 Feb 7;34(1):1-9. doi: 10.4274/mirt.galenos.2025.16023.
- Background: PubMed 35301240Emmett L, Papa N, Buteau J, Ho B, Liu V, Roberts M, Thompson J, Moon D, Sheehan-Dare G, Alghazo O, Agrawal S, Murphy D, Stricker P, Hope TA, Hofman MS. The PRIMARY Score: Using Intraprostatic 68Ga-PSMA PET/CT Patterns to Optimize Prostate Cancer Diagnosis. J Nucl Med. 2022 Nov;63(11):1644-1650. doi: 10.2967/jnumed.121.263448. Epub 2022 Mar 17.
- Background: PubMed 38112777Akcay K, Kibar A, Sahin OE, Demirbilek M, Beydagi G, Asa S, Aghazada F, Toklu T, Selcuk NA, Onal B, Kabasakal L. Prediction of clinically significant prostate cancer by [68 Ga]Ga-PSMA-11 PET/CT: a potential tool for selecting patients for active surveillance. Eur J Nucl Med Mol Imaging. 2024 Apr;51(5):1467-1475. doi: 10.1007/s00259-023-06556-y. Epub 2023 Dec 19.
- Background: PubMed 38614820Cornford P, van den Bergh RCN, Briers E, Van den Broeck T, Brunckhorst O, Darraugh J, Eberli D, De Meerleer G, De Santis M, Farolfi A, Gandaglia G, Gillessen S, Grivas N, Henry AM, Lardas M, van Leenders GJLH, Liew M, Linares Espinos E, Oldenburg J, van Oort IM, Oprea-Lager DE, Ploussard G, Roberts MJ, Rouviere O, Schoots IG, Schouten N, Smith EJ, Stranne J, Wiegel T, Willemse PM, Tilki D. EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer-2024 Update. Part I: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2024 Aug;86(2):148-163. doi: 10.1016/j.eururo.2024.03.027. Epub 2024 Apr 13.
- 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.
Levent Kabasakal, Prof. MD principal investigator
Istanbul University - Cerrahpasa
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Risk Prostate Cancer and Clinically Significant Prostate Cancer, run by Istanbul University - Cerrahpasa at 10 sites 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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Levent Kabasakal, Prof. MD (00905323667908, lkabasakal@tsnm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Diagnostic Accuracy of the Istanbul PSMA PET/CT Criteria (IPPC) for Detecting Clinically Significant Prostate Cancer (csPCa) (time frame: Baseline imaging; confirmed at prostatectomy or through 2-year follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07168616, which also lists 4 linked publications.
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 15 Sep 2025.