Know Cancer

or
forgot password

Evaluation of SpaceOARâ„¢ System When Used to Create Space Between the Rectum and Prostate in Men Undergoing IG-IMRT for Localized Stage T1-T2 Prostate Cancer: A Randomized, Multicenter, Parallel Arm Controlled Clinical Study


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Evaluation of SpaceOARâ„¢ System When Used to Create Space Between the Rectum and Prostate in Men Undergoing IG-IMRT for Localized Stage T1-T2 Prostate Cancer: A Randomized, Multicenter, Parallel Arm Controlled Clinical Study


Inclusion Criteria:



- Subjects greater than 18 years old

- Subjects must have pathologically confirmed invasive adenocarcinoma of the
prostate and must be planning to undergo IMRT

- Subjects must have clinical stage T1 or T2 as determined from a biopsy taken within 6
months of the baseline/screening visit with Gleason Score less than or equal to 7

- Subjects Screening/Baseline laboratory testing must meet the following laboratory
value criteria: PSA less than or equal to 20 ng/mL,hematocrit greater than 30%,serum
creatinine less than 2.0 mg/dl, serum AST and ALT less than 2.5 times upper limit of
institution normal, and serum bilirubin less than 2.0 mg/dl

- Subject or authorized representative, has been informed of the nature of the study
and has provided written informed consent, approved by the appropriate Institutional
Review Board (IRB) of the respective clinical site

Exclusion Criteria:

- Prostate greater than 80cc documented within 3 months preceding the
Screening/Baseline visit

- Subjects with extracapsular extension of the prostate cancer, with greater than 50%
of the number of biopsy cores positive for cancer, metastatic disease, other ongoing
cancers which will be treated during the study, or subjects for whom pelvic lymph
node radiotherapy is planned

- Subjects with any prior invasive malignancy (except non-melanomatous skin cancer)
unless the subject has been disease free for a minimum of 5 years.

- Subjects who are indicated for androgen deprivation therapy or who have been treated
with androgen therapy within the prior 3 months.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects achieving a reduction of 25% or greater in percent volume of the rectum receiving at least 70 Gy measured from CT scans acquired pre and post SpaceOAR hydrogel injection

Outcome Time Frame:

3 months post index procedure

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

AGX-11-001-US

NCT ID:

NCT01538628

Start Date:

January 2012

Completion Date:

May 2014

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Spacer
  • Prostatic Neoplasms

Name

Location

Foundation for Cancer Research and EducationPhoenix, Arizona  85013
University of RochesterRochester, New York  14642
Emory UniversityAtlanta, Georgia  30322
CentraState Medical CenterFreehold, New Jersey  07728
Radiological Associates of SacramentoSacramento, California  95816
Upstate Medical UniversitySyracuse, New York  13210
University Hospitals Case Medical CenterCleveland, Ohio  44106
Oregon Urology InstituteSpringfield, Oregon  97477
The Urology Center of ColoradoDenver, Colorado  80211
21st Century OncologyCape Coral, Florida  33990
Associated Medical Professionals of NYSyracuse, New York  13210
Urological Surgeons of Northern CaliforniaCampbell, California  95008
Lakewood Ranch Oncology Center/21st Century OncologyBradenton, Florida  34202
Johns Hopkins University Department of Radiation Oncology and Molecular Radiation SciencesBaltimore, Maryland  21231
Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center)Owings Mills, Maryland  21117
Advanced Radiation Centers of New YorkLake Success, New York  11042
21st Century OncologyMyrtle Beach, South Carolina  29577
Peninsula Cancer CenterPoulsbo, Washington  98370
Northern Nevada Radiation OncologyReno, Nevada  89521
Western New York Urology Associates, LLC and D/B/A Cancer Care of WNYErie, Niagara, and Chautauqua County, New York  14267