Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDHT PET Scan | Diagnostic Test | — | UNRESOLVED |
| PSMA PET Scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- newly diagnosed very high risk locally advanced and/or oligometastatic prostate cancer
- interventionNames
- Diagnostic Test: PSMA PET Scan
- Diagnostic Test: FDHT PET Scan
- type
- OTHER
- label
- metastatic, castration resistant prostate cancer
- interventionNames
- Diagnostic Test: PSMA PET Scan
- Diagnostic Test: FDHT PET Scan
- type
- OTHER
- label
- newly diagnosed prostate cancer with planned radical prostatectomy
- interventionNames
- Diagnostic Test: PSMA PET Scan
- Diagnostic Test: FDHT PET Scan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
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