NCT05582876Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 366 (estimated)
- First submitted
- 11 Oct 2022
- Start date
- 10 Jan 2023
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Medical University of Bialystok
- Diseases
- Prostate cancer
- NCT number
- NCT05582876
What you commit to
- Study type: Interventional
- Planned participants: 366
- From 10 Jan 2023 to the primary completion date, 31 Jan 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of metallic foreign bodies / implants / prostheses / stimulators etc. inside the body, the possession of which is a contraindication to the MR 3T examination
Other illness
- 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
- Age \<18 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: Male · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Clinical Hospital in Białystok Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok Coordinator of this site? Confirm its status | Bialystok | Poland | Not yet recruiting |
| Laboratory of Molecular Imaging and Technology Development Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Białystok Oncology Center Maria Skłodowska-Curie Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź Coordinator of this site? Confirm its status | Lodz | Poland | Not yet recruiting |
| Center of Oncology of the Lublin Region St. Jana z Dukli Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.