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

NCT05109884 | Completed

• 1 other identifier: PC_LBI:AD_V3
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Interventions

PSMA PET Scan DIAGNOSTIC_TEST

\[68Ga\]Ga-PSMAHBED-CC (Ga-PSMA) PET Scan

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 DIAGNOSTIC_TEST

\[18F\]-fluoro-5α-dihydrotestosterone (18F-FDHT) PET Scan

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: November 5, 2021
• Study Start: February 1, 2020
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)