Imaging test with a PSMA tracer to plan prostate cancer treatment
Tests a PSMA-based scan to guide treatment in men with prostate cancer.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Bialystok, Bydgoszcz, Lodz, and Lublin, PolandSee the 7 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT05582876, who can take part
Where in Poland
- Białystok Oncology Center Maria Skłodowska-CurieBialystok, PolandTaking people
- Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in BiałystokBialystok, PolandNot yet recruiting
- Laboratory of Molecular Imaging and Technology DevelopmentBialystok, PolandTaking people
- University Clinical Hospital in BiałystokBialystok, PolandTaking people
- Oncology Center named after prof. F. Łukaszczyk in BydgoszczBydgoszcz, PolandTaking people
- Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in ŁódźLodz, PolandNot yet recruiting
- Center of Oncology of the Lublin Region St. Jana z DukliLublin, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of Bialystok
- Trial code
- NCT05582876
- Record updated
- 8 May 2025
- Original description
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 treatmentRead full original descriptionShow less
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
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
Inclusion: 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: Presence of metallic foreign bodies / implants / prostheses / stimulators etc. inside the body, the possession of which is a contraindication to the MR 3T examination; 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; Age <18 years; Claustrophobia; Patient size precluding PET / MR examination due to diameter gantry; Participating in another clinical trial; Lack of informed consent to participate in the study.