Comparison of PET Imaging Patterns With PSMA and AR Expression in Prostate Cancer and Bladder Cancer
NCT ID: NCT05109884
Last Updated: 2023-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
10 participants
INTERVENTIONAL
2020-02-01
2021-04-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer
NCT06122584
PET/MRI in Patients With Suspected Prostate Cancer
NCT02659527
Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors
NCT03453528
Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
NCT06335914
18F-PSMA-1007 PET Imaging to Detect Primary Prostate Cancer
NCT04487847
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer
PSMA PET Scan
\[68Ga\]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan
FDHT PET Scan
\[18F\]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan
metastatic, castration resistant prostate cancer
PSMA PET Scan
\[68Ga\]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan
FDHT PET Scan
\[18F\]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan
newly diagnosed prostate cancer with planned radical prostatectomy
PSMA PET Scan
\[68Ga\]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan
FDHT PET Scan
\[18F\]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan
primary bladder cancer with planned radical cystectomy
PSMA PET Scan
\[68Ga\]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan
FDHT PET Scan
\[18F\]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PSMA PET Scan
\[68Ga\]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan
FDHT PET Scan
\[18F\]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Vienna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Markus Zeitlinger
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Vienna
Vienna, , Austria
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PC_LBI:AD_V3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.