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Multicentre, Phase 3 Trial to Determine Diagnostic Value of 68Ga-PSMA-11 (in PET/CT and PET/MRI) in Intermediate and High-Risk Prostate Cancer Patients before Introduction of Radical Treatment and in Patients Diagnosed with Biochemical Failure Following Radical Treatment
EU CTIS ID: 2024-516556-17-00
What this study is testing
Determination of diagnostic applications of 68Ga-PSMA-11 (in PET/CT and PET/MRI) for staging of prostate cancer and precise location of neoplastic lesions
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent to participate in the study
- Group 2: Prostate adenocarcinoma confirmed by biopsy or histopathological examination
- Group 2: After radical treatment
- Group 2: For patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng/ml not earlier than 6 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) <3 months. PSA in at least two consecutive tests within the last 6 months before eligibility (last determination within 6 weeks before eligibility, not necessary to do on the day of the visit))
- Or: for patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng/ml (we consider the lowest PSA concentration during ADT + 2ng/ml)
- Or: if radical treatment included the inclusion of hormone therapy: three consecutive PSA increases, at least two of which measured with an increase of at least 50% above the nadir level, and a current PSA > 2 ng/mL
You likely can't join if
- Lack of informed consent to participate in the study
- Age < 18 years
- The presence of metallic foreign bodies/implants/prostheses/stimulators, etc. inside the body, the possession of which is a contraindication to the 3T MR examination
- Claustrophobia
- Patient sizes preventing PET/MR study due to gantry diameter. In cases of doubt, consultation with the research center Bialystok or Bydgoszcz, respectively, is advisable
- Known contraindications to the use of radiopharmaceutical products or excipients (e.g., renal failure and allergy to the ingredients of the preparation)
See the full eligibility criteria
Who can join
- Signed informed consent to participate in the study
- Group 2: Prostate adenocarcinoma confirmed by biopsy or histopathological examination
- Group 2: After radical treatment
- Group 2: For patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng/ml not earlier than 6 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) <3 months. PSA in at least two consecutive tests within the last 6 months before eligibility (last determination within 6 weeks before eligibility, not necessary to do on the day of the visit))
- Or: for patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng/ml (we consider the lowest PSA concentration during ADT + 2ng/ml)
- Or: if radical treatment included the inclusion of hormone therapy: three consecutive PSA increases, at least two of which measured with an increase of at least 50% above the nadir level, and a current PSA > 2 ng/mL
- Age ≥18 years
- Group 1: patients with a diagnosis or high probability of CRC of intermediate and high risk according to ISUP, in whom it is planned to implement radical treatment
- Group 1: Prostate adenocarcinoma confirmed by biopsy and histopathology or negative BAC with mpMR and PSA results indicating n high risk of RGK
- Group 1: Results indicative of intermediate-risk 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
- Group 1: Creatinine value that allows the study to be performed safely PET/MR with contrast agent: creatinine less than or equal to 1.5x the upper limit of normal, creatinine clearance >60 mL/min
- Group 1: Performed pelvic/prostate mpMR examination, no earlier than 90 days prior to inclusion in the project
- Group 1: Status after prostate BAC (results may be inconclusive)
- Group 2: Patients with CRC after radical treatment, with recurrence of biochemical according to EAU criteria, in whom further treatment is planned, and the imaging/molecular test results may change the therapeutic decision therapeutic decision:
What rules you out
- Lack of informed consent to participate in the study
- Age < 18 years
- The presence of metallic foreign bodies/implants/prostheses/stimulators, etc. inside the body, the possession of which is a contraindication to the 3T MR examination
- Claustrophobia
- Patient sizes preventing PET/MR study due to gantry diameter. In cases of doubt, consultation with the research center Bialystok or Bydgoszcz, respectively, is advisable
- Known contraindications to the use of radiopharmaceutical products or excipients (e.g., renal failure and allergy to the ingredients of the preparation)
- Hormone therapy (applies to group 1 only)
- Treatment for malignant neoplasm unrelated to the prostate gland (skin cancer) within the last 5 years.
- Participation in another clinical trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.