Using PSMA PET/CT imaging to help choose which men with low-risk prostate cancer can enter active surveillance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective diagnostic accuracy study that adds a delayed (120-minute) Ga-68 PSMA PET/CT scan into the diagnostic pathway for men with biopsy-confirmed ISUP Grade 1 prostate cancer. Images will be classified using the Istanbul PSMA PET/CT Criteria (IPPC) into three risk categories (no/low uptake, indeterminate, focal high uptake) and compared to standard mpMRI and biopsy findings. The study will use radical prostatectomy pathology or long-term clinical follow-up as the reference standard for clinically significant disease. The goal is to refine patient selection for active surveillance to reduce unnecessary interventions while avoiding missed higher-grade cancers.

Why it matters

Who can join: the full rules

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

Where it's running

• Yeditepe University
  Istanbul, Turkey, 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, Turkey (Türkiye) Recruiting
• Acibadem University Maslak Hospital
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Levent Kabasakal, Prof. MD — Istanbul University - Cerrahpasa
• Study coordinator: Levent Kabasakal, Prof. MD
• Email: lkabasakal@tsnm.org
• Phone: 00905323667908

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transperineal vs Transrectal Cognitive Fusion Biopsy for Prostate Cancer

  This study tests whether a transperineal cognitive fusion biopsy works as well as the traditional transrectal approach for detecting clinically significant prostate cancer in men with suspicious mpMRI findings.

  Recruiting Ankara Etlik City Hospital · Ankara, Yenimahalle · NCT07710807

• Multi-Modal Imaging and Digital Pathology to Predict Clinically Significant Prostate Cancer

  A multi-center study tests a deep learning model that combines MRI, ultrasound, and digital pathology to see if it can predict clinically significant prostate cancer non-invasively and help guide biopsies.

  Recruiting Guangxi Medical University · Liuzhou, Guangxi · NCT07614256

• Blood exosomal RNA test to diagnose clinically significant prostate cancer

  This study will test whether a blood-based exosome RNA signature can detect clinically significant prostate cancer in men with elevated PSA and suspicion for cancer.

  Recruiting at 10 sites Xijing Hospital · Chicago, Illinois and 9 other locations · NCT07492927

• Identifying risks in low-risk prostate cancer patients on active surveillance

  This study is testing whether advanced imaging and genetic tests can help doctors find out which men with low-risk prostate cancer on active surveillance might be at higher risk of their cancer getting worse.

  Recruiting Università Vita-Salute San Raffaele · Milan, Italy · NCT06866041

• Reducing prostate cancer treatment from 5 to 3 doses of radiotherapy

  This study is testing whether giving fewer doses of radiotherapy for early prostate cancer can still be just as effective and have fewer side effects for patients.

  Recruiting NHS Lothian · Edinburgh · NCT06117059

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.