Status:
COMPLETED
Study of Robotic Template Guidance for Needle Placement in Transperineal Prostate Brachytherapy
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This is a study that will try see if a device can help to better guide the needle that places prostate cancer treatment.
Detailed Description
Section 1- Background: Adenocarcinoma of the prostate will affect over 220,900 U.S. males this year, making it the most prevalent cancer in the nation.1 Prostate specific antigen (PSA) is a very usef...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00381966
Start Date
June 1 2006
End Date
December 1 2008
Last Update
November 26 2019
Active Locations (1)
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1
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231