I-SELECT
Prospective Evaluation of Istanbul PSMA PET/CT Criteria for Selecting Candidates for Active Surveillance in Low-Risk Prostate Cancer
Sponsor study identifier
observational
201
1 country
10
Study Start
September 1, 2025
Actual (reported)Primary Completion
September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2025
Actual (reported)September 5, 2025
Actual (reported)September 11, 2025
Actual (reported)September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Baseline imaging; confirmed at prostatectomy or through 2-year follow-up.
Reduction in Repeat Biopsy Rate
Assessed over 2 years.
Role of PSMA PET/CT During Active Surveillance
Baseline imaging; confirmed at prostatectomy or through 2-year follow-up.
delayed (120-minute) Ga-68 PSMA PET/CT and will be evaluated by using Istanbul PSMA PET/CT Criteria (IPPC)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Only Turkish patients
Yeditepe University
Istanbul, Turkey, 34000, Turkey (Türkiye)
Bilkent Şehir Hastanesi
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.
Emmett 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.
Levent Kabasakal, Prof. MD
Istanbul University - Cerrahpasa
First Submitted
September 5, 2025
First Posted
September 11, 2025
Study Start
September 1, 2025
Actual (reported)Primary Completion
September 15, 2026
Estimated (date passed)Plasma exoRNA-Based Liquid Biopsy to Diagnose Clinically Significant Prostate Cancer
Contact the study team to confirm eligibility.
Ankara, Turkey (Türkiye)
Gazi Yaşargil Egitim ve Arastirma Hastanesi
Diyarbakır, Turkey (Türkiye)
Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama hastanesi
Gaziantep, Turkey (Türkiye)
Acibadem University Altunizade Hospital
Istanbul, 34000, Turkey (Türkiye)
Acibadem University Maslak Hospital
Istanbul, 34000, Turkey (Türkiye)
Haseki Eğitim ve Araştırma Hastanesi
Istanbul, 34000, Turkey (Türkiye)
Istanbul University-Cerrahpaşa
Istanbul, 34000, Turkey (Türkiye)
SBÜ Başakşehir Çam Sakura Şehir hastanesi
Istanbul, 34000, Turkey (Türkiye)
Sisli Hamidiye Etfal Eğitim ve Arastırma Hastanesi
Istanbul, 34000, Turkey (Türkiye)
Akcay 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.
Cornford 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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 15, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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