Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: PET/CT
PET/MR
68Ga-PSMA-11
PSA
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
Collaborators: name: Medical Research Agency, Poland
First posted: 2022-10-17
Enrollment: 366
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET/MR and PET/CT
timeFrame: 24 months
Secondary outcomes:
measure: Establishing a therapeutic path depending on the PET/MR and PET/CT
timeFrame: 24 months
measure: Detection of the site of recurrence
timeFrame: 24 months
measure: Determination of PSA concentration
timeFrame: 24 months
measure: Number of participants with adverse events related to 68Ga-PSMA-11
timeFrame: 24 months
measure: Absorbed radiation dose
timeFrame: 24 months
measure: Evaluation of pharmacoeconomic data
timeFrame: 24 months
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Białystok Oncology Center Maria Skłodowska-Curie
city: Białystok
country: Poland
facility: University Clinical Hospital in Białystok
city: Białystok
country: Poland
facility: Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
city: Białystok
country: Poland
facility: Laboratory of Molecular Imaging and Technology Development
city: Bydgoszcz
country: Poland
facility: Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz
city: Lublin
country: Poland
facility: Center of Oncology of the Lublin Region St. Jana z Dukli
city: Łódź
country: Poland
facility: Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź
Study officials:
References: