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

Not Applicable

Completed

• Conditions: Prostate Cancer

• 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

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2021-04-19
• Study Completion: 2021-04-19
• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17

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

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlation of PET imaging parameters with PSMA and AR expression levels	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).

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria