Clinical trial · Interventional
Multi-modality Prostate Cancer Image Guided Interventions
NCT04009174CI-TRIAL-00074463IGPC-2completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a non-randomized, prospective trial of men who are scheduled for radical prostatectomy for treatment of prostate cancer, or repeat biopsy for localized prostate cancer as standard of care and who will undergo a series of pre-operative multi-modality imaging studies. Post intervention, hybrid imaging maps (HIM) will be generated and the predictions of the HIM (3D location, volume and grade of cancer) will be correlated with actual pathology results to gauge the performance of the HIM in both radical prostatectomy and biopsy settings.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imaging Panel | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imaging Panel
- description
- Patients who provided written informed consent and found to be eligible for study were asked to complete Positron Emission Tomography (PET) + Dynamic CT imaging, PET/MRI (with endorectal coil) and 3D-Transrectal ultrasound prior to standard of care radical prostatectomy.
- interventionNames
- Other: Imaging Panel
Primary outcomes (1)
- measure
- Hybrid Imaging Map (HIM) Validation
- timeFrame
- Within two years of study completion.
- description
- We will determine if individualized hybrid imaging maps (HIMs) based on a pre-operative imaging panel accurately predicts the actual cancer distribution found in the whole mount prostatectomy specimens obtained from the surgery.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of informed consent for this study * Male, aged 18 years or older * Pathologically confirmed prostate cancer on previous biopsy * Suitable for and consenting to Radical Prostatectomy for treatment, or repeat biopsy as standard of care Exclusion Criteria: * Prior therapy for prostate cancer (including hormone therapy), with the exception of radiation therapy for Cohort 2 only * Use of 5-alpha reductase inhibitors, i.e. finasteride (Proscar) or dutasteride (Avodart) within 6 months of study start. Patients undergoing a 6-month washout period prior to study start will be eligible. * Inability to comply with the pre-operative imaging panel * Patients scheduled for radical prostatectomy with prostate size exceeding dimensions for whole mount pathology slides * Allergy to contrast agents to be used as part of the imaging panel * Sickle cell disease or other anemias * Insufficient renal function (eGFR \< 60 mL/min/1.73 m2) * Residual bladder volume \> 150 cc (determined by post-void ultrasound) * Hip prosthesis, vascular grafting that is MRI incompatible or sources of artifact within the pelvis * Contraindication to MRI * pacemaker or other electronic implants * known metal in the orbit * cerebral aneurysm clips
References
Publications (3)
- BACKGROUNDWard A, Crukley C, McKenzie C, Montreuil J, Gibson E, Gomez JA, et al. Registration of in vivo prostate magnetic resonance images to digital histopathology images. MICCAI'10 Proceedings of the 2010 international conference on Prostate cancer imaging: computer-aided diagnosis, prognosis, and intervention; Bejing, China. Berlin: Springer-Verlag; 2010.
- DERIVEDYang DM, Alfano R, Bauman G, Thiessen JD, Chin J, Pautler S, Moussa M, Gomez JA, Rachinsky I, Gaed M, Chung KJ, Ward A, Lee TY. Short-duration dynamic [18F]DCFPyL PET and CT perfusion imaging to localize dominant intraprostatic lesions in prostate cancer: validation against digital histopathology and comparison to [18F]DCFPyL PET/MR at 120 minutes. EJNMMI Res. 2021 Oct 15;11(1):107. doi: 10.1186/s13550-021-00844-0. PMID 34652551
- DERIVEDYang DM, Li F, Bauman G, Chin J, Pautler S, Moussa M, Rachinsky I, Valliant J, Lee TY. Kinetic analysis of dominant intraprostatic lesion of prostate cancer using quantitative dynamic [18F]DCFPyL-PET: comparison to [18F]fluorocholine-PET. EJNMMI Res. 2021 Jan 4;11(1):2. doi: 10.1186/s13550-020-00735-w. PMID 33394284