Study of Image-guided Dosimetry for Interstitial Prostate Brachytherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00426959
First received: January 24, 2007
Last updated: November 13, 2012
Last verified: November 2012
  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:

  1. Acute and late toxicity as assessed by IPSS, SHIM, and EPIC questionnaires at multiple follow-up intervals.
  2. 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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Feasibility Study of Image-guided, Dynamic Dosimetry for Permanent Interstitial Prostate Brachytherapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluation of the feasibility of using the RUF system. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Evaluation of real-time optimization in the operating room environment. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute & late toxicity as assessed by IPSS, SHIM, & EPIC questionnaires. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • PSA-free survival. [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: February 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Image Guided Dynamic Dosimetry
    Image Guided Dynamic Dosimetry
  Show Detailed Description

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

Additional Information:
No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00426959     History of Changes
Other Study ID Numbers: J-04100
Study First Received: January 24, 2007
Last Updated: November 13, 2012
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

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 22, 2014