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

Not Applicable
Completed
Conditions
Prostate Cancer
Interventions
Diagnostic Test: PSMA PET Scan
Diagnostic Test: FDHT PET Scan
Registration Number
NCT05109884
Lead Sponsor
Medical University of Vienna
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancerFDHT PET Scan-
newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancerPSMA PET Scan-
metastatic, castration resistant prostate cancerPSMA PET Scan-
newly diagnosed prostate cancer with planned radical prostatectomyFDHT PET Scan-
primary bladder cancer with planned radical cystectomyPSMA PET Scan-
metastatic, castration resistant prostate cancerFDHT PET Scan-
newly diagnosed prostate cancer with planned radical prostatectomyPSMA PET Scan-
primary bladder cancer with planned radical cystectomyFDHT PET Scan-
Primary Outcome Measures
NameTimeMethod
Correlation of PET imaging parameters with PSMA and AR expression levelsthrough 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).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Medical University of Vienna

🇦🇹

Vienna, Austria

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