Actively Recruiting
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
Led by Medical University of Bialystok · Updated on 2025-05-08
366
Participants Needed
7
Research Sites
168 weeks
Total Duration
On this page
Sponsors
M
Medical University of Bialystok
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed or with high probability of intermediate and high-risk prostate cancer based on ISUP criteria planning radical treatment
- Prostate adenocarcinoma confirmed by biopsy and histopathology
- Moderate risk defined as Gleason score 7 or cT2b or PSA 10-20 ng/ml, or high risk defined as Gleason score >7 or cT2c or PSA >20 ng/ml
- Creatinine level safe for PET/MR with contrast: creatinine 3.5 times the upper limit of normal and creatinine clearance >60 mL/min
- Age 18 years or older
- Signed informed consent
- Pelvic or prostate multiparametric MRI performed within 30 days before study inclusion
- For patients with biochemical recurrence after radical treatment: PSA levels and PSA doubling time meeting EAU criteria
- Signed informed consent
You will not qualify if you...
- Presence of metallic foreign bodies, implants, prostheses, stimulators, or devices contraindicating MR 3T examination
- Claustrophobia
- Body size too large for PET/MR scanner gantry
- Known contraindications to radiopharmaceuticals or auxiliary substances (e.g., renal failure or allergies)
- Treatment for malignant neoplasms not related to the prostate
- Participation in another clinical trial
- Lack of informed consent
- Age under 18 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Białystok Oncology Center Maria Skłodowska-Curie
Bialystok, Poland, 15-027
Actively Recruiting
2
University Clinical Hospital in Białystok
Bialystok, Poland, 15-276
Actively Recruiting
3
Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
Bialystok, Poland, 15-471
Not Yet Recruiting
4
Laboratory of Molecular Imaging and Technology Development
Bialystok, Poland, 15-540
Actively Recruiting
5
Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz
Bydgoszcz, Poland, 85-796
Actively Recruiting
6
Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź
Lodz, Poland, 93-513
Not Yet Recruiting
7
Center of Oncology of the Lublin Region St. Jana z Dukli
Lublin, Poland, 20-090
Actively Recruiting
Research Team
E
Ewa Sierko, Professor
CONTACT
C
Clinical Research Support Center Medical University of Bialystok
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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