Prostate Cancer
Conditions
Keywords
PET/CT, PET/MR, 68Ga-PSMA-11, PSA
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
Interventions
RADIATIONRadiopharmaceutical 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.
Sponsors
Medical Research Agency, Poland
Medical University of Bialystok
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| 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 |
| 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). |
Countries
Poland
Contacts
Primary ContactEwa Sierko, Professor
Backup ContactClinical Research Support Center Medical University of Bialystok
Outcome results
None listed