Clinical trial · Interventional
Guided Biopsy for Mapping Prostate Cancer
Hybrid Imaging Technique (HIT) Guided Biopsy to Map Prostatic Adenocarcinoma in Patients Undergoing Prostatectomy
NCT01007214CI-TRIAL-00013899HITterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not able to meet accrual
Summary
Brief summary (as posted)
Evaluate the accuracy of HIT guided biopsies for mapping tumor foci with men undergoing prostatectomy.
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 |
|---|---|---|---|
| Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostate cancer
- description
- A total of 30 patients diagnosed with prostate cancer who have elected to undergo radical prostatectomy are enrolled over a six year period.
- interventionNames
- Procedure: Prostatectomy
Primary outcomes (1)
- measure
- Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping.
- timeFrame
- Six years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed diagnosis of prostate cancer * Patients must have elected to undergo radical prostatectomy using an open, laparoscopic or robotic approach * Patients must be at least 18 years of age and able to provide written informed consent. * No history of radiotherapy, chemotherapy or hormone therapy within 6 months of surgery * Primary tumor must be amenable to surgical removal for curative intent * Patients must have ECOG-performance status 0 or 1 (appendix II) * Patients must have no history of rectal or anal disease. * Patients must have adequate organ function as defined by the following criteria: * Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\])≤2.5x local laboratory upper limit of normal (ULN), or AST and ALT ≤5x ULN if liver function abnormalities are due to underlying malignancy * Total serum bilirubin ≤1.5 x ULN * Absolute neutrophil count(ANC)≥1,500/microL * Platelets≥lOO,OOO/microL * Hemoglobin≥9.0 g/dL * Serum calcium≤10.2mg/dL (correct for low albumin if necessary; calcium + (normal albumin - serum albumin)x 0.8) * Patients must have serum creatinine\<2 mg/dL or serum creatinine clearance (CrCl)\>40ml/min(CrCl= Wt(kg)x(140-age)\*/72xCr. level,\*female x 0.85) Inclusion of minorities: * Members of all races and ethnic groups are eligible for this trial. Women and children are not eligible since prostate cancer is not diagnosed in these groups.
References
Publications (0)
Data not yet available
No reference posted for this study.