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NCT Number: NCT05582876

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

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

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Białystok Oncology Center Maria Skłodowska-Curie, Bialystok, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiopharmaceutical 68Ga-PSMA-11 PET/CT

Radiation

The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w.

Primary outcomes

  1. Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET/MR and PET/CT

    Time frame: 24 months

    Validation of the diagnostic value of 68Ga-PSMA-11 (in PET / CT and PET / MR techniques) in the assessment stage of prostate cancer and precise assessment of the location of neoplastic changes.

Secondary outcomes

  1. Establishing a therapeutic path depending on the PET/MR and PET/CT

    Time frame: 24 months

    Percentage of patients with 68Ga-PSMA-11 PET / CT and 68Ga-PSMA-11 PET / MR will lead to a change in the therapeutic path

  2. Detection of the site of recurrence

    Time frame: 24 months

    Comparison of the frequency of detecting the site of recurrence after examination with standard methods, 68Ga-PSMA-11 PET / CT and 68Ga-PSMA-11 PET / MR (only for the second group)

  3. Determination of PSA concentration

    Time frame: 24 months

    Determination of the PSA concentration at which the 68Ga-PSMA-11 PET / MR test enables detection of local or regional recurrence (only for the second group)

  4. Number of participants with adverse events related to 68Ga-PSMA-11

    Time frame: 24 months

    Serious adverse events are not expected. The radiotracer 68Ga-PSMA-11 is dose by the intravenous route in trace amounts and does not affect the patient's well-being.

    The use of 68Ga-PSMA-11 is contraindicated in kidney failure and allergies to the ingredients of the preparation (all patients will have their serum creatinine measured before the test).

  5. Absorbed radiation dose

    Time frame: 24 months

    Assessment and comparison of the absorbed radiation dose during the 68Ga-PSMA-11 PET / CT examination and 68Ga-PSMA-11 PET / MR

  6. Evaluation of pharmacoeconomic data

    Time frame: 24 months

    Comparison of the costs of the procedures planned for performance after the first visit, and those that were actually made after conducting the assessed tests

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Support Center Medical University of Bialystok

CONTACT

85 686 53 86

Ewa Sierko, Professor

CONTACT

[email protected]

85 664 67 83

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Collaborators

  • Medical Research Agency, Poland

Registry information

Acronym: PROSPETMR2021

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 17, 2022
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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