NCT07168616

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Sep 2025Jun 2028

Study Start

First participant enrolled

September 1, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 5, 2025

Last Update Submit

September 11, 2025

Conditions

Low Risk Prostate CancerClinically Significant Prostate Cancer

Keywords

PSMA PET/CTLow risk prostate canceractive surveillanceprostate cancerclinically significant prostate cancerDiagnosis of prostate cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Reduction in Repeat Biopsy Rate

    Assessed over 2 years.

Other Outcomes (1)

  • Role of PSMA PET/CT During Active Surveillance

    Baseline imaging; confirmed at prostatectomy or through 2-year follow-up.

Interventions

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)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Only Turkish patients

You may qualify if:

  • 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
  • No prior PSMA PET imaging
  • No evidence of extra-prostatic disease on mpMRI
  • Signed informed consent for study procedures

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Yeditepe University

Istanbul, Turkey, 34000, Turkey (Türkiye)

RECRUITING

Bilkent Şehir Hastanesi

Ankara, Turkey (Türkiye)

RECRUITING

Gazi Yaşargil Egitim ve Arastirma Hastanesi

Diyarbakır, Turkey (Türkiye)

RECRUITING

Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama hastanesi

Gaziantep, Turkey (Türkiye)

RECRUITING

Acibadem University Altunizade Hospital

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Acibadem University Maslak Hospital

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Haseki Eğitim ve Araştırma Hastanesi

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Istanbul University-Cerrahpaşa

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

SBÜ Başakşehir Çam Sakura Şehir hastanesi

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Sisli Hamidiye Etfal Eğitim ve Arastırma Hastanesi

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 11827525BACKGROUND

  • 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.

    PMID: 9635676BACKGROUND

  • 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.

    PMID: 38112777BACKGROUND

  • 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.

    PMID: 38614820BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Levent Kabasakal, Prof. MD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Levent Kabasakal, Prof. MD

CONTACT

00905323667908lkabasakal@tsnm.org

Nalan Alan, Prof. MD.

CONTACT

00905322940667nalanselcuk@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nuclear Medicine, Medical Doctor

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 11, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

June 1, 2028

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations

TU(10)