Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance
NCT ID: NCT07168616
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
201 participants
OBSERVATIONAL
2025-09-01
2028-06-01
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Ga-68 PSMA11 PET/CT
delayed (120-minute) Ga-68 PSMA PET/CT and will be evaluated by using Istanbul PSMA PET/CT Criteria (IPPC)
Eligibility Criteria
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Inclusion Criteria
* 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
* No prior PSMA PET imaging
* No evidence of extra-prostatic disease on mpMRI
* Signed informed consent for study procedures
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Yeditepe University
OTHER
Yedikule Training and Research Hospital
OTHER
Acibadem University
OTHER
Ankara Yildirim Beyazıt University
OTHER
University of Gaziantep
OTHER
Istanbul Training and Research Hospital
OTHER_GOV
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
OTHER
Sisli Hamidiye Etfal Training and Research Hospital
OTHER
Haseki Training and Research Hospital
OTHER
Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Levent Kabasakal
Professor of Nuclear Medicine, Medical Doctor
Principal Investigators
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Levent Kabasakal, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Istanbul University - Cerrahpasa
Locations
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Yeditepe University
Istanbul, Turkey, Turkey (Türkiye)
Bilkent Şehir Hastanesi
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, , Turkey (Türkiye)
Acibadem University Maslak Hospital
Istanbul, , Turkey (Türkiye)
Haseki Eğitim ve Araştırma Hastanesi
Istanbul, , Turkey (Türkiye)
Istanbul University-Cerrahpaşa
Istanbul, , Turkey (Türkiye)
SBÜ Başakşehir Çam Sakura Şehir hastanesi
Istanbul, , Turkey (Türkiye)
Sisli Hamidiye Etfal Eğitim ve Arastırma Hastanesi
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Seravalli J, Kumar M, Ragsdale SW. Rapid kinetic studies of acetyl-CoA synthesis: evidence supporting the catalytic intermediacy of a paramagnetic NiFeC species in the autotrophic Wood-Ljungdahl pathway. Biochemistry. 2002 Feb 12;41(6):1807-19. doi: 10.1021/bi011687i.
Drachenberg CB, Abruzzo LV, Klassen DK, Bartlett ST, Johnson LB, Kuo PC, Kumar D, Papadimitriou JC. Epstein-Barr virus-related posttransplantation lymphoproliferative disorder involving pancreas allografts: histological differential diagnosis from acute allograft rejection. Hum Pathol. 1998 Jun;29(6):569-77. doi: 10.1016/s0046-8177(98)80005-1.
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.
Other Identifiers
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2024-KAEK-21/1153
Identifier Type: -
Identifier Source: org_study_id
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