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
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.
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
Sex
MALE
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET/MR and PET/CT — 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.
Trial sites (7)
Facility
City
Region
Status
Białystok Oncology Center Maria Skłodowska-Curie
Bialystok
Poland
Recruiting
University Clinical Hospital in Białystok
Bialystok
Poland
Recruiting
Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
Bialystok
Poland
Not Yet Recruiting
Laboratory of Molecular Imaging and Technology Development
Bialystok
Poland
Recruiting
Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz
Bydgoszcz
Poland
Recruiting
Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź
Lodz
Poland
Not Yet Recruiting
Center of Oncology of the Lublin Region St. Jana z Dukli
Lublin
Poland
Recruiting
More Medical University of Bialystok trials in Poland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.