Study of Image-guided Dosimetry for Interstitial Prostate Brachytherapy
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 Primary endpoint of this study will be evaluation of the feasibility of using the RUF system and of performing real-time optimization in the operating room environment.
The Secondary endpoints of this study will be:
- Acute and late toxicity as assessed by IPSS, SHIM, and EPIC questionnaires at multiple follow-up intervals.
- PSA-free survival.
The target population will be patients with a diagnosis of adenocarcinoma of the prostate who are seen in consultation at the Johns Hopkins Hospital.
Approximately 360 patients per year with the diagnosis of prostate cancer are seen in the Department of Radiation Oncology at Johns Hopkins Hospital. Of these patients, approximately 45% have low-risk (T1a-T2a, Gleason 6 or less, PSA 10 ng/ml or less) or intermediate-risk disease and are suitable for brachytherapy based on disease risk. Within this group of patients, approximately 70% are eligible for brachytherapy based on gland size and no prior transurethral resection of prostate (TURP).
Approximately 80% of patients offered brachytherapy at consultation decide to receive their treatment at Johns Hopkins. Overall, we currently perform 2 brachytherapy procedures per week on average, for a yearly total of approximately 90 cases.
For purposes of homogeneity of treatment and patient population, this protocol will only enroll patients currently treated at this institution with brachytherapy alone, and will not enroll patients (intermediate or high risk disease) who will require external beam radiation in addition to brachytherapy.
|Locally Confined Adenocarcinoma of the Prostate||Device: Image Guided Dynamic Dosimetry||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
|Official Title:||Feasibility Study of Image-guided, Dynamic Dosimetry for Permanent Interstitial Prostate Brachytherapy|
- Evaluation of the feasibility of using the RUF system. [ Time Frame: 5 years ]
- Evaluation of real-time optimization in the operating room environment. [ Time Frame: 5 years ]
- Acute & late toxicity as assessed by IPSS, SHIM, & EPIC questionnaires. [ Time Frame: 5 years ]
- PSA-free survival. [ Time Frame: 5 year ]
|Study Start Date:||February 2005|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Device: Image Guided Dynamic Dosimetry
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426959
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins University|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Danny Song, M.D.||Johns Hopkins University|