Comparison of PET Imaging Patterns With PSMA and AR Expression in Prostate Cancer and Bladder Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
PSMA PET Scan
FDHT PET Scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer
metastatic, castration resistant prostate cancer
newly diagnosed prostate cancer with planned radical prostatectomy
primary bladder cancer with planned radical cystectomy
Arm Description
Outcomes
Primary Outcome Measures
Correlation of PET imaging parameters with PSMA and AR expression levels
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
Full Information
NCT ID
NCT05109884
First Posted
September 28, 2021
Last Updated
March 16, 2023
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT05109884
Brief Title
Comparison of PET Imaging Patterns With PSMA and AR Expression in Prostate Cancer and Bladder Cancer
Official Title
Comparison of PET Imaging Patterns With Prostate-specific Membrane Antigen and Androgen Specific Receptor Expression Patterns in Prostate Cancer and Bladder Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
April 19, 2021 (Actual)
Study Completion Date
April 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer
Arm Type
Other
Arm Title
metastatic, castration resistant prostate cancer
Arm Type
Other
Arm Title
newly diagnosed prostate cancer with planned radical prostatectomy
Arm Type
Other
Arm Title
primary bladder cancer with planned radical cystectomy
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
PSMA PET Scan
Intervention Description
[68Ga]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan
Intervention Type
Diagnostic Test
Intervention Name(s)
FDHT PET Scan
Intervention Description
[18F]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan
Primary Outcome Measure Information:
Title
Correlation of PET imaging parameters with PSMA and AR expression levels
Description
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).
Time Frame
through study completion, an average of 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of PET Imaging Patterns With PSMA and AR Expression in Prostate Cancer and Bladder Cancer
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