Study of Robotic Template Guidance for Needle Placement in Transperineal Prostate Brachytherapy

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

This is a study that will try see if a device can help to better guide the needle that places prostate cancer treatment.

Key facts

Study ID: NCT00381966
Run by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
People needed: 5
Starts: 2006-06-01
Expected to finish: 2008-12-01
Last updated by the study team: 2019-11-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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