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

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

The aim of multicentre phase 3 trial is evidence diagnostic value of 68Ga-PSMA-11 (in PET / CT and PET / MR techniques) in patients with high-risk and intermediate prostate cancer before radical treatment and in diagnosed patients biochemical recurrence after radical treatment

Key facts

Study ID

NCT05582876

Run by

Medical University of Bialystok

People needed

366

Starts

2023-01-10

Expected to finish

2026-03-31

Last updated by the study team

2025-05-08

Who can join

Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Laboratory of Molecular Imaging and Technology Development — Bialystok, Poland (enrolling)
• University Clinical Hospital in Białystok — Bialystok, Poland (enrolling)
• Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz — Bydgoszcz, Poland (enrolling)
• Center of Oncology of the Lublin Region St. Jana z Dukli — Lublin, Poland (enrolling)
• Białystok Oncology Center Maria Skłodowska-Curie — Bialystok, Poland (enrolling)
• Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok — Bialystok, Poland
• Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź — Lodz, Poland

Full record on ClinicalTrials.gov

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