Protocol Title:

A Pilot Study of Robotic Template Guidance For Needle Placement in Transperineal Prostate Brachytherapy
 

Protocol Status:

Closed
 

Protocol Number:

J0511
 

Type of Cancer:

Prostate
 

Principal Investigator :

Danny Y Song, MD
 

Research Nurse:

Shirl DiPasquale, R.N.
 

Phase Number:

Pilot Study
 

General Eligibility:

Any male greater than or equal to 18 years of age with 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 > 70. Prostate volume by TRUS < 50 cc. International Prostate symptom score (IPSS) must be 18 or less and must have signed a study-specific consent form prior to registration.
 

Purpose:

Primary Outcome Measures:

This will be a feasibility trial of a therapeutic device the needle positioner device using the system in an actual operating room environment and determining acceptable positioning effectiveness.
 

Treatment:

Five patients will be enrolled onto the trial. Pre-Study Entry Post Brachytherapy Month 3 (+/- 4 weeks) History/physical Exam Xa X KPS Xa PSA Xa X Chest X-ray Xa Xb CT of pelvis Xa Xb Ultrasound volume Xa Bone scan (if clinically indicated) Xa

  1. within 6 weeks prior to day 1 of brachytherapy

  2. up to 1 day post brachytherapy RADIATION THERAPY AND RESEARCH INTERVENTIONS The patient population who will be offered this protocol are those who are currently offered brachytherapy as standard treatment at our institution. The clinical protocol will not affect what patients experience during the procedure.

Implant procedure As is our routine, within the week prior to implantation the patient will undergo a transrectal ultrasound study to determine the volume of the prostate and estimate the number of sources required. A preliminary implant plan will be developed based on the pre-operative ultrasound.