Prostate Cancer
Conditions
Brief summary
Patients suffering either from newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer (cohort A), metastatic castration-resistant prostate cancer (mCRPC, cohort B), newly diagnosed postate cancer with planned radical prostatectomy (cohort C) or primary bladder cancer with planned radical cystectomy (cohort D) as identified by a multidisciplinary team of specialists, will be included. PET imaging patterns using PSMA- and FDHT PET scans will be correlated with prostate-specific membrane antigen and androgen specific receptor expression patterns in prostate cancer and bladder cancer.
Interventions
DIAGNOSTIC_TESTPSMA PET Scan
\[68Ga\]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan
DIAGNOSTIC_TESTFDHT PET Scan
\[18F\]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Cohort A: * Age 18-75 years * Histologically or cytologically confirmed adenocarcinoma of the prostate with very high risk for the development of metastases (defined as PSA ≥20 or Gleason Score ≥8 or ≥cT3) and/or oligometastatic (T any, N positive, M any or T any, N any, M positive) * Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1 * Planned radical prostatectomy * ≤ 5 osseous metastasis * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation * Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures Cohort B - mCRPC: * Age ≥ 18 years * Histologically or cytologically confirmed prostate adenocarcinoma. * Presence of skeletal or nodal metastases according to one of the following criteria: * Confirmed pathological fracture related to the disease OR * Confirmation of distant bone and/or nodal metastases on CT or MRI scan or bone scintigraphy. OR * Positive pathology report of metastatic lesion. * Disease progression despite ADT as indicated by: * PSA increase that is ≥ 2 ng/mL and ≥ 25% above the minimum PSA as reached during ADT or above the pre-treatment level, if no response was observed and which is confirmed by a second value 1 or more weeks later. OR * Progression of measurable lymph nodes (short axis ≥ 15 mm) or visceral lesion measurable per RECIST OR * New metastatic lesions appearing on bone scan/imaging * Chemical or surgical castration * Eastern Cooperative Oncology Group (ECOG) Performance status 0-2. * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation * Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures Cohort C: * Age ≥ 18 years * Histologically or cytologically confirmed prostate adenocarcinoma. * Planned radical prostatectomy * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation * Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures Cohort D: * Age ≥ 18 years * Histologically or cytologically confirmed bladder cancer. * Planned radical cystectomy * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation * Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures
Exclusion criteria
Cohort A: * Tumour infiltration of the rectum or pelvic wall * Visceral metastasis * HIV positive * Any contraindication for surgery * Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures. * Any contraindication for performing a PET/MRI scan (if applicable) * Patient's not eligible for the size of the PET/MRI gantry Cohort B - mCRPC: * HIV positive * Any contraindication for tissue biopsy (if tissue biopsy is planned) * Any contraindication for surgery (if surgery is planned) * Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures. * Any contraindication for performing a PET/MRI scan (if applicable) * Patient's not eligible for the size of the PET/MRI gantry Cohort C: * Any contraindication for surgery * Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures. * Any contraindication for performing a PET/MRI scan (if applicable) * Patient's not eligible for the size of the PET/MRI gantry Cohort D: * Any contraindication for surgery * Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures. * Any contraindication for performing a PET/MRI scan (if applicable) * Patient's not eligible for the size of the PET/MRI gantry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of PET imaging parameters with PSMA and AR expression levels | through study completion, an average of 3 years | To correlate PET imaging parameters with prostate-specific membrane antigen (PSMA), and androgen specific receptor expression levels in tissue biopsy samples using immuno-histochemical methods (IHC). |
Countries
Austria
Outcome results
None listed