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

Last updated: May 5, 2025
Sponsor: Medical University of Bialystok
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

Radiopharmaceutical 68Ga-PSMA-11 PET/CT

Clinical Study ID

NCT05582876
2020/ABM/01/00074
  • Ages 18-99
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

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) orhigh (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, creatinineclearance> 60 mL / min

  • Age ≥18 years

  • Signing informed consent to participate in the study

  • Pelvic / prostate mpMR examination performed, not earlier than 30 days beforeinclusion 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 withPSAdt (PSA doubling time) <3 months PSA on at least two consecutive studies inconsecutive last 6 months before qualification (last determination within 6 weeksbefore qualification) Or

  • In patients after radical radiotherapy: biochemical recurrence defined as nadir PSA

  • 2 ng / ml
  • Age ≥18 years

  • Signing informed consent

Exclusion

Exclusion Criteria:

  • Presence of metallic foreign bodies / implants / prostheses / stimulators etc.inside the body, the possession of which is a contraindication to the MR 3Texamination

  • 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

Study Design

Total Participants: 366
Treatment Group(s): 1
Primary Treatment: Radiopharmaceutical 68Ga-PSMA-11 PET/CT
Phase:
Study Start date:
January 10, 2023
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Białystok Oncology Center Maria Skłodowska-Curie

    Białystok, 15-027
    Poland

    Active - Recruiting

  • Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok

    Białystok, 15-471
    Poland

    Site Not Available

  • Laboratory of Molecular Imaging and Technology Development

    Białystok, 15-540
    Poland

    Active - Recruiting

  • University Clinical Hospital in Białystok

    Białystok, 15-276
    Poland

    Active - Recruiting

  • Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz

    Bydgoszcz, 85-796
    Poland

    Active - Recruiting

  • Center of Oncology of the Lublin Region St. Jana z Dukli

    Lublin, 20-090
    Poland

    Active - Recruiting

  • Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź

    Łódź, 93-513
    Poland

    Site Not Available

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