Status:
COMPLETED
Cross-linked Hyaluronan Gel Reduces Rectal Toxicity Due to Radiation Therapy for Prostate Cancer
Lead Sponsor:
Cancer Center of Irvine
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to determine if cross-linked hyaluronan gel reduces the dose of radiation delivered to the rectum and the rectal toxicity of radiotherapy for localized prostate ca...
Detailed Description
The main risk associated with transperineal injection of cross-linked hyaluronan gel into the anterior perirectal fat is infection. Prophylactic antibiotics will be given, resulting in a \<5% risk. An...
Eligibility Criteria
Inclusion
- Histologically-confirmed adenocarcinoma of the prostate, clinical stage T1c-T2c, NX, N0, M0.
- Nodes determined to be negative by imaging methods will be classified as NX. Only nodes determined to be negative by surgical sampling will be classified as N0.
- Prostate cancer biopsy grading by Gleason score classification is mandatory.
- No prior pelvic radiotherapy. Induction hormonal therapy for less than or equal to 6 months is acceptable.
- Prostate volume by TRUS \< 50 cc prior to HDR brachytherapy.
- Prostate specific antigen (PSA) less than or equal to 30 ng/ml.
- Patient has provided informed consent.
Exclusion
- Clinical stage T3 or T4.
- Clinical evidence of lymph node involvement (N1).
- Clinical evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate.
- Allergy to avian products.
- Significant mental, medical, or physical impairment.
- Prisoners.
- Employees of the Cancer Center of Irvine.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00882232
Start Date
September 1 2008
End Date
September 1 2009
Last Update
February 15 2013
Active Locations (1)
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1
Cancer Center of Irvine
Irvine, California, United States, 92618