Clinical trial · Interventional
Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers
Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19
NCT00676286CI-TRIAL-00022853completedPhase 1ClinicalTrials.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 study will use high field MRI (3 Tesla), PET and biomarker to follow prostate cancers and determine if these tests can detect cancers that become aggressive.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3T MR Imaging | Procedure | — | UNRESOLVED |
| C-Choline PET Scanning | Procedure | — | UNRESOLVED |
| Gene Rearrangement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary objective to determine if we can accrue patients to this study in a timely manner.
- timeFrame
- 2 years
Secondary outcomes (8)
- measure
- Patient compliance
- timeFrame
- Patients followed for 5 years from baseline
- measure
- Optimal imaging parameters to characterize prostate cancers
- timeFrame
- patients followed for 5 years from baseline
- measure
- feasibility of detecting gene arrangements in prostate biopsies
- timeFrame
- patients followed for 5 years from baseline
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven adenocarcinoma of the prostate * Registration must occur within 16 weeks of last biopsy * History and physical exam (including DRE) within 8 weeks prior to registration * Patients must have indolent prostate cancer including all of the following: Low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease * Patients must have a minimum of six biopsies (sextant) at registration * PSA test within 8 weeks registration * Creatinine level below 100 umol/L within 8 weeks of registration * Patients must have no contraindications to MRI scans * No history of previous malignancies except non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy * Patients must be reliable for follow up Exclusion Criteria: * Patient does not have histologically-proven adenocarcinoma of the prostate * Last biopsy greater than 16 weeks prior to registration * History and physical exam (including DRE) greater that 8 weeks prior to registration * Patient does not have indolent disease * Patient has less than six sextant biopsies at registration * PSA test done greater than 8 weeks from registration * Creatinine level greater than 100 umol/L within 8 weeks of registration * Contraindications to MRI scans * History of previous malignancies other than non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy * Patients that are not reliable for follow up
References
Publications (0)
Data not yet available
No reference posted for this study.