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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: PSMA PET Scan; Diagnostic test: FDHT PET Scan

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer	Diagnostic test: PSMA PET Scan; [68Ga]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan; Diagnostic test: FDHT PET Scan; [18F]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan
Other: metastatic, castration resistant prostate cancer	Diagnostic test: PSMA PET Scan; [68Ga]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan; Diagnostic test: FDHT PET Scan; [18F]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan
Other: newly diagnosed prostate cancer with planned radical prostatectomy	Diagnostic test: PSMA PET Scan; [68Ga]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan; Diagnostic test: FDHT PET Scan; [18F]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan
Other: primary bladder cancer with planned radical cystectomy	Diagnostic test: PSMA PET Scan; [68Ga]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan; Diagnostic test: FDHT PET Scan; [18F]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): April 19, 2021
• Study Completion (Actual): April 19, 2021

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PC_LBI:AD_V3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No