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
- Conditions
- Intermediate and high-risk prostate cancer
- Registration Number
- 2024-516556-17-00
- Lead Sponsor
- Medical University Of Bialystok
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Male
- Target Recruitment
- 366
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:
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
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients for whom, following 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI and precise location of neoplastic lesions, prostate cancer staging was changed according to ISUP and TNM classification Percentage of patients for whom, following 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI and precise location of neoplastic lesions, prostate cancer staging was changed according to ISUP and TNM classification
Percentage of patients, in whom, with 68Ga-PSMA PET/MRI and 68Ga-PSMA location of prostate cancer relapse was detected (detection rate) – Study Group 2 only Percentage of patients, in whom, with 68Ga-PSMA PET/MRI and 68Ga-PSMA location of prostate cancer relapse was detected (detection rate) – Study Group 2 only
- Secondary Outcome Measures
Name Time Method Percentage of patients, in whom 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI prompts an alteration of the treatment plan Percentage of patients, in whom 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI prompts an alteration of the treatment plan
Percentage of patients, in whom 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI prompts finding of the relapse location (Group 2 only) Percentage of patients, in whom 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI prompts finding of the relapse location (Group 2 only)
PSA levels, with which the relapse location was found with 68Ga-PSMA-11 PET/MRI (Group 2 only) PSA levels, with which the relapse location was found with 68Ga-PSMA-11 PET/MRI (Group 2 only)
Number and type of serious adverse effects reported during 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI Number and type of serious adverse effects reported during 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI
Mean absorbed radiation dose during 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI Mean absorbed radiation dose during 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI
Pharmacoeconomic data (cost of procedures planned to be performed after visit 1 and those actually performed after the investigated diagnostics were carried out) Pharmacoeconomic data (cost of procedures planned to be performed after visit 1 and those actually performed after the investigated diagnostics were carried out)
Trial Locations
- Locations (6)
Laboratorium Obrazowania Molekularnego i Rozwoju Technologii Sp. z o.o.
🇵🇱Bialystok, Poland
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
🇵🇱Bialystok, Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku
🇵🇱Bialystok, Poland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
🇵🇱Bydgoszcz, Poland
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
🇵🇱Lublin, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
🇵🇱Lodz, Poland
Laboratorium Obrazowania Molekularnego i Rozwoju Technologii Sp. z o.o.🇵🇱Bialystok, PolandMałgorzata MojsakSite contact48857485970malgorzata.mojsak@umb.edu.pl