Phase
Condition
Prostate Cancer
Prostate Disorders
Prostate Cancer, Early, Recurrent
Treatment
Radiopharmaceutical 68Ga-PSMA-11 PET/CT
Clinical Study ID
Ages 18-99 Male
Study Summary
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
Connect with a study center
Białystok Oncology Center Maria Skłodowska-Curie
Białystok, 15-027
PolandActive - Recruiting
Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
Białystok, 15-471
PolandSite Not Available
Laboratory of Molecular Imaging and Technology Development
Białystok, 15-540
PolandActive - Recruiting
University Clinical Hospital in Białystok
Białystok, 15-276
PolandActive - Recruiting
Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz
Bydgoszcz, 85-796
PolandActive - Recruiting
Center of Oncology of the Lublin Region St. Jana z Dukli
Lublin, 20-090
PolandActive - Recruiting
Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź
Łódź, 93-513
PolandSite Not Available
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