Cross-linked Hyaluronan Gel Reduces Rectal Toxicity Due to Radiation Therapy for Prostate Cancer

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

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 cancer.

Key facts

Study ID

NCT00882232

Run by

Cancer Center of Irvine

People needed

10

Starts

2008-09-01

Expected to finish

2009-09-01

Last updated by the study team

2013-02-15

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cancer Center of Irvine — Irvine, California, United States

Full record on ClinicalTrials.gov

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