Using PSMA PET/CT and MRI‑RSI to find and outline prostate tumors in men with newly diagnosed prostate cancer
Prospective Comparison of PSMA PET/CT and MRI-RSI (Restriction Spectrum Imaging) for Intraprostatic Tumor Detection and Delineation in Primary Prostate Cancer Patients
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | German Oncology Center, Cyprus Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Limassol) |
| Trial ID | NCT07568613 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Prior work shows PSMA PET improves lesion detection and MRI‑RSI is promising, but direct prospective comparisons for intraprostatic tumor delineation remain limited.
Eligibility criteria
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 this trial is running
Limassol
- German Oncology Center — Limassol, Cyprus (Recruiting)
Study contacts
- Study coordinator: Constantinos Zamboglou, Dr
- Email: kristis.vevis@goc.com.cy
- Phone: +35725208000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.