CompletedNCT05109884Updated Mar 17, 2023

Comparison of PET Imaging Patterns With PSMA and AR Expression in Prostate Cancer and Bladder Cancer

An interventional study of PSMA PET Scan and FDHT PET Scan in Prostate Cancer, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-17.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Diagnostic

From the registry’s dates

Registered 1 year 7 months after the study started (first participant enrolled Feb 2020, registered Sep 2021).

Phase: Not applicable
Study type: Interventional
Enrollment: 10
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Prostate Cancer

Browse trials for

Prostatic Neoplasms 6,370

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 10 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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.

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.

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

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

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

Other
newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer
Diagnostic Test: PSMA PET Scan · Diagnostic Test: FDHT PET Scan
Other
metastatic, castration resistant prostate cancer
Diagnostic Test: PSMA PET Scan · Diagnostic Test: FDHT PET Scan
Other
newly diagnosed prostate cancer with planned radical prostatectomy
Diagnostic Test: PSMA PET Scan · Diagnostic Test: FDHT PET Scan
Other
primary bladder cancer with planned radical cystectomy
Diagnostic Test: PSMA PET Scan · Diagnostic Test: FDHT PET Scan

Interventions

Diagnostic testPSMA PET Scan
\[68Ga\]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan
Diagnostic testFDHT PET Scan
\[18F\]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan

What researchers measure

Primary outcomes

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).
Time frame: through study completion, an average of 3 years

Study locations

1 site

Medical University of Vienna
Vienna, 1090, Austria

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05109884
Lead sponsor: Medical University of Vienna
Responsible party: Markus Zeitlinger (Principal Investigator, Medical University of Vienna) — Principal investigator
First posted: Nov 5, 2021
Start date: Feb 1, 2020
Primary completion: Apr 19, 2021
Completion: Apr 19, 2021
Last update: Mar 17, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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