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Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Using PSMA PET/CT and MRI‑RSI to find and outline prostate tumors in men with newly diagnosed prostate cancer

Official title: Prospective Comparison of PSMA PET/CT and MRI-RSI (Restriction Spectrum Imaging) for Intraprostatic Tumor Detection and Delineation in Primary Prostate Cancer Patients

Run by German Oncology Center, Cyprus · NCT07568613 · Data updated 2026-11-12

The study will test whether PSMA PET/CT or MRI‑RSI finds and outlines prostate tumors more accurately than standard mpMRI in men newly diagnosed with intermediate‑ to very high‑risk prostate cancer.

More Prostate Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment50 (estimated)
SponsorGerman Oncology Center, Cyprus
Academic / other
Drugs / interventionsradiation
Locations1 site (Limassol)
StatusRecruiting
StartedAugust 18, 2025
Main results expectedJanuary 31, 2027
Study endsJuly 31, 2027
Registry record updatedMay 6, 2026
Trial IDNCT07568613 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 18 or older with newly diagnosed, histologically confirmed unfavorable intermediate‑, high‑, or very high‑risk prostate cancer, ECOG 0–2, life expectancy ≥5 years, and who can undergo mpMRI, PSMA PET/CT, and MR‑guided targeted biopsy.

Probably not a fit

Men with low‑risk disease, no visible tumor on imaging, contraindications to MRI, prior pelvic radiotherapy, recent ADT, very high PSA (>100 ng/mL), or recent TUR‑P are unlikely to benefit from this protocol.

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

What this trial studies

This prospective, single‑center study enrolls men with newly diagnosed unfavorable intermediate‑, high‑, or very high‑risk prostate cancer to undergo PSMA PET/CT, MRI‑RSI, and standard mpMRI. MR‑guided transrectal ultrasound (TRUS) targeted biopsies will serve as the reference to confirm tumor presence and location. Investigators will compare detection rates, tumor volume delineation, and interobserver variability of manual contouring across the imaging methods. The aim is to determine whether either advanced modality identifies more tumor or produces more consistent outlines than mpMRI.

Why it matters

Potential benefit: If successful, the approach could give more accurate tumor detection and clearer tumor outlines for better-targeted biopsies and focal radiotherapy.

How similar studies have gone: Prior work shows PSMA PET improves lesion detection and MRI‑RSI is promising, but direct prospective comparisons for intraprostatic tumor delineation remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Newly diagnosed and histologically confirmed primary prostate cancer
* NCCNv4.2024 risk groups: unfavorable intermediate risk, high-risk and very high-risk
* Males, age ≥ 18 years
* ECOG performance status 0-2
* Estimated life expectancy ≥ 5 years
* PSMA-PET/CT-hybrid imaging performed \<3 months
* MRI-targeted biopsy on PIRADs v2.1 lesion ≥3 performed \<6 months

Exclusion Criteria:

* Contraindications for MRI imaging
* No visible tumor on PSMA PET and mpMRI (defined by PIRADs v2.1 ≤2 lesion)
* TUR-P of the prostate \<1 year ago
* Initial PSA \>100 ng/ml
* History of cancer (exception: localized skin tumours, tumours treated ≥5 years previously with curative intent and no evidence of recurrent disease)
* Previous radiation therapy to the pelvis
* ADT or ADT + other systemic therapy before inclusion

Where it's running

  • German Oncology Center
    Limassol, Cyprus     Recruiting

Study contacts

Similar studies

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

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.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.