Prostate CancerNCT05109884
Comparison of PET Imaging Patterns With PSMA and AR Expression in Prostate Cancer and Bladder Cancer
A study testing PSMA PET Scan and FDHT PET Scan in people with Prostate Cancer, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSMA PET Scan and FDHT PET Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2020to 19 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of PET Imaging Patterns With Prostate-specific Membrane Antigen and Androgen Specific Receptor Expression Patterns in Prostate Cancer and Bladder Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- PSMA PET Scan, FDHT PET Scan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET ScanDiagnostic test
[68Ga]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan
FDHT PET ScanDiagnostic test
[18F]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan
| Study group | Role | What they receive |
|---|---|---|
| newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer | Other | Not described Receives: Diagnostic Test: PSMA PET Scan; Diagnostic Test: FDHT PET Scan |
| metastatic, castration resistant prostate cancer | Other | Not described Receives: Diagnostic Test: PSMA PET Scan; Diagnostic Test: FDHT PET Scan |
| newly diagnosed prostate cancer with planned radical prostatectomy | Other | Not described Receives: Diagnostic Test: PSMA PET Scan; Diagnostic Test: FDHT PET Scan |
| primary bladder cancer with planned radical cystectomy | Other | Not described Receives: Diagnostic Test: PSMA PET Scan; Diagnostic Test: FDHT PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Feb 2020
- Primary completion19 Apr 2021
- Study completion19 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Zeitlinger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109884
- Sponsor's protocol ID
- PC_LBI:AD_V3
- Status last verified
- Mar 2023
- First submitted
- 28 Sep 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PET Imaging Patterns With Prostate-specific Membrane Antigen and Androgen Specific Receptor Expression Patterns in Prostate Cancer and Bladder Cancer
- ClinicalTrials.gov ID
- NCT05109884
- Acronym / sponsor ID
- PC_LBI:AD_V3
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer | Other | Diagnostic Test: PSMA PET Scan, Diagnostic Test: FDHT PET Scan |
| metastatic, castration resistant prostate cancer | Other | Diagnostic Test: PSMA PET Scan, Diagnostic Test: FDHT PET Scan |
| newly diagnosed prostate cancer with planned radical prostatectomy | Other | Diagnostic Test: PSMA PET Scan, Diagnostic Test: FDHT PET Scan |
| primary bladder cancer with planned radical cystectomy | Other | Diagnostic Test: PSMA PET Scan, Diagnostic Test: FDHT PET Scan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- 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
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA PET Scan[68Ga]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan | Diagnostic test | metastatic, castration resistant prostate cancer, newly diagnosed prostate cancer with planned radical prostatectomy, newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer, primary bladder cancer with planned radical cystectomy |
| FDHT PET Scan[18F]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan | Diagnostic test | metastatic, castration resistant prostate cancer, newly diagnosed prostate cancer with planned radical prostatectomy, newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer, primary bladder cancer with planned radical cystectomy |
Primary outcome
Correlation of PET imaging parameters with PSMA and AR expression levels
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA PET Scan and FDHT PET Scan in people with Prostate Cancer, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of PET imaging parameters with PSMA and AR expression levels (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.