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
NCT ID: NCT05582876
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
366 participants
INTERVENTIONAL
2023-01-10
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1- patient of middle and high risk of prostate cancer
Patients with diagnosis or high probability of prostate cancer medium and high risk according to ISUP for which implementation is planned radical treatment \[i.e. PSA≥10 ng / ml or GS ≥ 7 (ISUP ≥2) or ≥cT2b\].
Radiopharmaceutical 68Ga-PSMA-11 PET/CT
The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w.
Group 2- patient after radical treatment, at relapse biochemical
Prostate cancer patients after radical treatment, with recurrence biochemical tests according to the criteria of the European Society of Urology (EAU, European Association of Urology) \[at least double measurement PSA ≥0.2 ng / ml not earlier than 6-13 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) \<3 months or increase in PSA after radical radiotherapy\> 2 ng / ml above PSAnadir - the lowest PSA value found after the test treatment\] for whom further treatment is planned and the test result imaging / molecular imaging may alter the therapeutic decision
Radiopharmaceutical 68Ga-PSMA-11 PET/CT
The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w.
Interventions
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Radiopharmaceutical 68Ga-PSMA-11 PET/CT
The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
MALE
No
Sponsors
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Medical Research Agency, Poland
OTHER_GOV
Medical University of Bialystok
OTHER
Responsible Party
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Locations
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Białystok Oncology Center Maria Skłodowska-Curie
Bialystok, , Poland
University Clinical Hospital in Białystok
Bialystok, , Poland
Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
Bialystok, , Poland
Laboratory of Molecular Imaging and Technology Development
Bialystok, , Poland
Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz
Bydgoszcz, , Poland
Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź
Lodz, , Poland
Center of Oncology of the Lublin Region St. Jana z Dukli
Lublin, , Poland
Countries
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Central Contacts
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Clinical Research Support Center Medical University of Bialystok
Role: CONTACT
Facility Contacts
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Other Identifiers
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2020/ABM/01/00074
Identifier Type: -
Identifier Source: org_study_id
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