Intermediate and high-risk prostate cancer before introduction of radical treatment and in patients diagnosed with biochemical failure following radical treatment MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 68Ga-PSMA-11
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 68Ga-PSMA-HBED-CC
Current Sponsor code: 68Ga-PSMA-11
Other descriptive name: 68Ga-PSMA-HBED-CC
Concentration
Sponsors
Uniwersytet Medyczny w Bialymstoku
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria will be eligible for the study: - Age =18 years - Signing informed consent to participate in the study Group 1. Patients with a diagnosis or high probability of intermediate and high risk CRC according to ISUP, in whom radical treatment is planned to be implemented - Prostate adenocarcinoma confirmed by biopsy and histopathological examination - Results indicative of intermediate (Gleason score 7 or cT2b OR PSA 10-20 ng/ml) or high (Gleason score > 7 OR cT2c or PSA > 20 ng/ml) risk ISUP RGK - Creatinine value to safely perform PET/MR with contrast medium: creatinine less than or equal to 1.5x upper limit of normal, creatinine clearance >60 mL/min - Performed mpMR study of the pelvis/prostate, no more than 90 days prior to inclusion in the project - Status after prostate BAC Group 2. - Age =18 years - Signing informed consent to participate in the study Patients with CRC after radical treatment, with biochemical recurrence according to EAU criteria, in whom further treatment is planned and the result of the imaging/molecular study may change the therapeutic decision: - Prostate adenocarcinoma confirmed by histopathology - After radical treatment 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) 2 ng/mL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 183 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 183
Exclusion criteria
Exclusion criteria: A person who is found to have at least one of the following will be excluded from the study listed below: - No informed consent to participate in the study - Age < 18 years - 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 size preventing PET/MR examination due to the diameter of the gantry. In doubtful cases, consultation with the research centre Bialystok or Bydgoszcz respectively is advisable - Known contraindications to the use of radiopharmaceuticals or excipients (e.g. renal failure and allergy to the components of the preparation) - Hormone therapy (applies to group 1 only) - Treatment for a malignant neoplasm unrelated to the prostate gland (skin cancer) within the last 5 years. - Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 with personalized dosimetry.;Secondary Objective: - To compare incidence of treatment plan alterations following standard diagnostics 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI - To compare incidence of relapse location following standard diagnostics, 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI (Group 2 only) - To determine concentration of Prostate Specific Antigen (PSA) justifying 68Ga-PSMA-11 PET/MRI (Group 2 only) - To assess and compare safety of 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI - To assess and compare absorbed radiation dose during 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI - To assess pharmacoeconomic data (compare costs of procedures planned after visit 1 and those actually performed after the investigated diagnostics were carried out) ;Primary end point(s): - 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 (International Society of Urological Pathology) 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 ;Timepoint(s) of evaluation of this end point: - 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 (International Society of Urological Pathology) 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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) - 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 - 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) ;Timepoint(s) of evaluation of this end point: It is planned to determine PSA concentration during the visit V0, V2 and V3. The total amount of blood during one blood collection - 6.8 ml. | — |
Countries
Poland
Contacts
Public ContactClinical Trial Information Point
Osrodek Wsparcia Badan Klinicznych, Uniwersytet Medyczny w Bialymstoku
Outcome results
None listed