Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medical University of Vienna
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
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)
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)
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)
Clareo Health | Comparison of PET Imaging Patterns With PSMA and AR Expression in Prostate Cancer and Bladder Cancer
