Study of Image-Guided Dosimetry for Interstitial Prostate Brachytherapy - Full Text View

Purpose

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.

Study Population:

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.

Condition	Intervention	Phase
Locally Confined Adenocarcinoma of the Prostate	Device: Image Guided Dynamic Dosimetry	Phase I

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	Feasibility Study of Image-Guided, Dynamic Dosimetry for Permanent Interstitial Prostate Brachytherapy

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:

Evaluation of the feasibility of using the RUF system.
Evaluation of real-time optimization in the operating room environment.

Secondary Outcome Measures:

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

Estimated Enrollment:	6
Study Start Date:	February 2005
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed, locally confined adenocarcinoma of the prostate
PSA of less than 10 ngmL
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 greater than 70
Prostate volume by TRUS less than 50 cc
International Prostate symptom score must be 18 or less
Signed study-specific consent form prior to registration

Exclusion Criteria:

Clinical or Pathological Lymph node involvement,
Evidence of distant metastases
Radical surgery for carcinoma of the prostate
Chemotherapy or pelvic radiation therapy
Previous transurethral resection of the prostate
Previous or concurrent cancers other than basal or squamous cell skin cancers unless disease free for at least 5 years.
Significant obstructive symptoms
Major medical or psychiatric illness which, in the investigator's opinion, Hip prosthesis
Anatomic or medical condition (such as prior abdominal perineal resection or anal stricture) which would preclude the use of TRUS Implanted device or apparatus which might obstruct visibility of the implanted sources on fluoroscopy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426959

Locations


United States, Maryland
	The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins University
	Baltimore, Maryland, United States, 21231

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

Department of Defense

Investigators


Principal Investigator:	Danny Song, M.D.	Johns Hopkins University

More Information

The Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences This link exits the ClinicalTrials.gov site

Study ID Numbers:	J-04100
First Received:	January 24, 2007
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00426959
Health Authority:	United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:

Adenocarcinoma of the prostate

PSA of less than 10 ng/mL

Combined Gleason score 6 or less

International Prostate Symptom Score (IPSS) must <or= to 18

Study placed in the following topic categories:

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 23, 2008

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center Department of Defense
Information provided by:	Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00426959