Comparison of PET Imaging Patterns With PSMA and AR Expression in Prostate Cancer and Bladder Cancer
- Conditions
- Prostate Cancer
- Interventions
- Diagnostic Test: PSMA PET ScanDiagnostic Test: FDHT PET Scan
- Registration Number
- NCT05109884
- Lead Sponsor
- Medical University of Vienna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer FDHT PET Scan - newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer PSMA PET Scan - metastatic, castration resistant prostate cancer PSMA PET Scan - newly diagnosed prostate cancer with planned radical prostatectomy FDHT PET Scan - primary bladder cancer with planned radical cystectomy PSMA PET Scan - metastatic, castration resistant prostate cancer FDHT PET Scan - newly diagnosed prostate cancer with planned radical prostatectomy PSMA PET Scan - primary bladder cancer with planned radical cystectomy FDHT PET Scan -
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria