Protocol Title:

Feasibility Study of Image-guided, Dynamic Dosimetry for Permanent Interstitial Prostate Brachytherapy

Protocol Status:

Closed

Protocol Number:

J04100

Type of Cancer:

Prostate

Principal Investigator :

Danny Y Song, MD

Research Nurse:

Shirl DiPasquale, R.N.

Phase Number:

Feasability Study

General Eligibility:

Locally confined adenocarcinoma of the prostate, Clinical stages T1b - T2a, PSA of less than 10 ng/mL, Combined Gleason score 6 or less, with no individual Gleason score of 4 or 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 18 or less, and signed study-specific consent form prior to registration

Purpose:

Primary Outcome Measures:
Evaluation of the feasibility of using the RUF system and evaluation of real-time optimization in the operating room environment.
Secondary Outcome Measures:

Acute & late toxicity as assessed by IPSS, SHIM, & EPIC questionnaires and PSA-free survival.

Treatment:

This will be a phase I study. This phase I study is not a standard drug dose escalation study, but rather a Clinical System Performance Evaluation Trial of a therapeutic device. However for purposes of this protocol we will refer to this portion of the trial as a phase I study. The purpose of this study is to demonstrate the feasibility and clinical practicability of the registered ultrasound and fluoroscopy (RUF) in combination with CMS Interplant system® in an initial cohort of 6 patients. This will involve demonstrating the feasibility of using the system in an actual operating room environment as well as obtaining a preliminary assessment of the accuracy and performance of the source location algorithm by comparing with postoperative CT dosimetry. The target population will be patients with a diagnosis of adenocarcinoma of the prostate who are seen in consultation at the Johns Hopkins Hospital.