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
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Radiopharmaceutical 68Ga-PSMA-11 PET/CT
- Registration Number
- NCT05582876
- Lead Sponsor
- Medical University of Bialystok
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 366
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1- patient of middle and high risk of prostate cancer Radiopharmaceutical 68Ga-PSMA-11 PET/CT Patients with diagnosis or high probability of prostate cancer medium and high risk according to ISUP for which implementation is planned radical treatment \[i.e. PSA≥10 ng / ml or GS ≥ 7 (ISUP ≥2) or ≥cT2b\]. Group 2- patient after radical treatment, at relapse biochemical Radiopharmaceutical 68Ga-PSMA-11 PET/CT 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
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events related to 68Ga-PSMA-11 24 months Serious adverse events are not expected. The radiotracer 68Ga-PSMA-11 is dose by the intravenous route in trace amounts and does not affect the patient's well-being.
The use of 68Ga-PSMA-11 is contraindicated in kidney failure and allergies to the ingredients of the preparation (all patients will have their serum creatinine measured before the test).Establishing a therapeutic path depending on the PET/MR and PET/CT 24 months Percentage of patients with 68Ga-PSMA-11 PET / CT and 68Ga-PSMA-11 PET / MR will lead to a change in the therapeutic path
Detection of the site of recurrence 24 months Comparison of the frequency of detecting the site of recurrence after examination with standard methods, 68Ga-PSMA-11 PET / CT and 68Ga-PSMA-11 PET / MR (only for the second group)
Determination of PSA concentration 24 months Determination of the PSA concentration at which the 68Ga-PSMA-11 PET / MR test enables detection of local or regional recurrence (only for the second group)
Evaluation of pharmacoeconomic data 24 months Comparison of the costs of the procedures planned for performance after the first visit, and those that were actually made after conducting the assessed tests
Absorbed radiation dose 24 months Assessment and comparison of the absorbed radiation dose during the 68Ga-PSMA-11 PET / CT examination and 68Ga-PSMA-11 PET / MR
Trial Locations
- Locations (7)
University Clinical Hospital in Białystok
🇵🇱Białystok, Poland
Laboratory of Molecular Imaging and Technology Development
🇵🇱Białystok, Poland
Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz
🇵🇱Bydgoszcz, Poland
Białystok Oncology Center Maria Skłodowska-Curie
🇵🇱Białystok, Poland
Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź
🇵🇱Łódź, Poland
Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
🇵🇱Białystok, Poland
Center of Oncology of the Lublin Region St. Jana z Dukli
🇵🇱Lublin, Poland