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

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of PET Imaging Patterns With Prostate-specific Membrane Antigen and Androgen Specific Receptor Expression Patterns in Prostate Cancer and Bladder Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: PSMA PET Scan
* Diagnostic Test: FDHT PET Scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |