Home › Trials › NCT05582876
Clinical trial Recruiting at 5 sites Interventional Ages 18 to 99 Men only

Using a special imaging technique to plan treatment for prostate cancer patients

Official title: Multicenter Assessment of Clinical Utility PET / MR With the Use of the Radiotracer 68Ga-PSMA-11 in Therapy Planning Personalized in Patients With Prostate Cancer

Run by Medical University of Bialystok · NCT05582876 · Data updated 2026-11-12

This study is testing a special imaging technique to see if it can help doctors better plan treatment for men with high-risk prostate cancer or those whose cancer has come back after treatment.

Quick facts

Study typeInterventional
Ages18 Years to 99 Years
SexMen only
Enrollment366 (estimated)
SponsorMedical University of Bialystok
Academic / other
Locations7 sites (Bialystok and 6 other locations)
StatusRecruiting
StartedJanuary 10, 2023
Main results expectedJanuary 31, 2026
Study endsMarch 31, 2026
Registry record updatedMay 8, 2025
Trial IDNCT05582876 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults diagnosed with medium to high-risk prostate cancer or those experiencing biochemical recurrence after radical treatment.

Probably not a fit

Patients with low-risk prostate cancer or those who do not meet the eligibility criteria may not benefit from this study.

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

What this trial studies

This multicenter trial evaluates the diagnostic value of the radiotracer 68Ga-PSMA-11 in PET/CT and PET/MR imaging for patients with high-risk and intermediate prostate cancer. It aims to assess its effectiveness in therapy planning before radical treatment and in patients experiencing biochemical recurrence after such treatment. The study includes patients diagnosed with prostate adenocarcinoma and those with biochemical recurrence, ensuring they meet specific eligibility criteria related to cancer risk and kidney function.

Why it matters

Potential benefit: If successful, this study could enhance personalized treatment planning for prostate cancer patients, potentially improving outcomes.

How similar studies have gone: Other studies using similar imaging techniques have shown promise in improving treatment planning for prostate cancer, suggesting a potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Group 1. Patients with diagnosis or high probability of medium and high prostate cancer according International Society of Urological Pathology (ISUP) risk for whom radical treatment is planned

* Prostate adenocarcinoma confirmed by biopsy and histopathological examination
* Results indicating a moderate RGK (Gleason score 7 or cT2b or PSA 10-20 ng / ml) or high (Gleason score\> 7 or cT2c or PSA\> 20 ng / ml) risk according to ISUP
* Creatinine value allowing for safe PET / MR examination with a contrast agent: creatinine less than or equal to 1.5 times the upper limit of normal, creatinine clearance\> 60 mL / min
* Age ≥18 years
* Signing informed consent to participate in the study
* Pelvic / prostate mpMR examination performed, not earlier than 30 days before inclusion in the study

Group 2. Patients with RGK after radical treatment, with biochemical recurrence according to EAU criteria, who are scheduled for further treatment and the result of the imaging / molecular examination may affect change of therapeutic decision:

* Prostate adenocarcinoma confirmed by biopsy and histopathological examination
* After radical treatment
* In patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng / ml not earlier than after 6-13 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) \<3 months PSA on at least two consecutive studies in consecutive last 6 months before qualification (last determination within 6 weeks before qualification) Or
* In patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng / ml
* Age ≥18 years
* Signing informed consent

Exclusion Criteria:

* Presence of metallic foreign bodies / implants / prostheses / stimulators etc. inside the body, the possession of which is a contraindication to the MR 3T examination
* Claustrophobia
* Patient size precluding PET / MR examination due to diameter gantry
* Known contraindications for the use of radiopharmaceuticals or substances auxiliary (e.g. renal failure and allergy to ingredients in the preparation)
* Treatment for malignant neoplasm not associated with the prostate gland
* Participating in another clinical trial
* Lack of informed consent to participate in the study
* Age \<18 years

Where it's running

  • Białystok Oncology Center Maria Skłodowska-Curie
    Bialystok, Poland     Recruiting
  • University Clinical Hospital in Białystok
    Bialystok, Poland     Recruiting
  • Laboratory of Molecular Imaging and Technology Development
    Bialystok, Poland     Recruiting
  • Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz
    Bydgoszcz, Poland     Recruiting
  • Center of Oncology of the Lublin Region St. Jana z Dukli
    Lublin, Poland     Recruiting
  • Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
    Bialystok, Poland     Not yet recruiting
Show 1 more location
  • Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź
    Lodz, Poland     Not yet 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.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Prostate Cancer 1464Medical University of Bialystok 14
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.