Clinical trial · Observational
Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance
Prospective Evaluation of Istanbul PSMA PET/CT Criteria for Selecting Candidates for Active Surveillance in Low-Risk Prostate Cancer
NCT07168616CI-TRIAL-00095110I-SELECTrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinically Significant Prostate Cancer | — | UNRESOLVED | — |
| Low Risk Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ga-68 PSMA11 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 1. Diagnostic Accuracy of the Istanbul PSMA PET/CT Criteria (IPPC) for Detecting Clinically Significant Prostate Cancer (csPCa)
- timeFrame
- Baseline imaging; confirmed at prostatectomy or through 2-year follow-up.
- description
- 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.
Secondary outcomes (1)
- measure
- Reduction in Repeat Biopsy Rate
- timeFrame
- Assessed over 2 years.
- description
- Percentage of patients avoiding unnecessary repeat biopsies due to IPPC classification, compared with historical AS protocols
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (4)
- BACKGROUNDAkcay 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. PMID 39917984
- BACKGROUNDEmmett 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. PMID 35301240
- BACKGROUNDAkcay 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 38112777
- BACKGROUNDCornford 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 38614820