N/A
N=5
Study of Robotic Template Guidance for Needle Placement in Transperineal Prostate Brachytherapy
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00381966 ↗Enrolled (actual)
5
Serious AEs
—
Results posted
Jun 2018
Primary outcome: Primary: Positioning Effectiveness as Determined by Confirmatory Measurements of Robotic Movements — 0.489 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- robotic placement device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positioning Effectiveness as Determined by Confirmatory Measurements of Robotic Movements |
0.489 | — |
| PRIMARY Utility of the Needle Position Device: Number of Adjustments Possible Out of Adjustments Attempted |
18; 36 | — |
Summary
This is a study that will try see if a device can help to better guide the needle that places prostate cancer treatment.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00381966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.