Clinical trial · Interventional
Study of Robotic Template Guidance for Needle Placement in Transperineal Prostate Brachytherapy
A Pilot Study of Robotic Template Guidance for Needle Placement in Transperineal Prostate Brachytherapy
NCT00381966CI-TRIAL-00041925J0511completedN/AResults postedClinicalTrials.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 study that will try see if a device can help to better guide the needle that places prostate cancer treatment.
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 |
|---|---|---|---|
| robotic placement device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic placement device
- description
- The intervention involves use of a robotic template to assist in placement of needles for prostate brachytherapy.
- interventionNames
- Device: robotic placement device
Primary outcomes (2)
- measure
- Positioning Effectiveness as Determined by Confirmatory Measurements of Robotic Movements
- timeFrame
- at time of intervention
- description
- Confirmatory measurements of robotic movements was assessed using infrared tracking to calculate mean error in millimeters.
- measure
- Utility of the Needle Position Device: Number of Adjustments Possible Out of Adjustments Attempted
- timeFrame
- at time of intervention
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion criteria are unchanged from our standard criteria for brachytherapy eligibility: * Histologically confirmed, locally confined adenocarcinoma of the prostate * Clinical stages T1b - T2b * PSA of less than 20 ng/mL * Combined Gleason score 7 or less, with no individual Gleason score of 5 * The patient has decided to undergo brachytherapy at the Johns Hopkins Hospital as treatment choice for his prostate cancer. * Karnofsky Performance Status (KPS) \> 70 * Prostate volume by TRUS \< 50 cc * International Prostate symptom score (IPSS) must be 18 or less * Signed study-specific consent form prior to registration Exclusion Criteria: * Stage T1a, or T3 or greater disease. * Clinical or Pathological Lymph node involvement (N1). * Evidence of distant metastases (M1). * Radical surgery for carcinoma of the prostate. * Previous Chemotherapy or pelvic radiation therapy * Previous transurethral resection of the prostate (TURP) * Significant obstructive symptoms (IPSS greater than 18) * Hip prosthesis. * Anatomic or medical condition (such as prior abdominal-perineal resection or anal stricture) which would preclude the use of TRUS
References
Publications (0)
Data not yet available
No reference posted for this study.