CompletedPhase 1

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

United States10 participantsStarted 2008-09

Plain-language 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 cancer.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Mean rectal dose without Hylaform vs with Hylaform

Timeframe: 8 months

Trial details

NCT IDNCT00882232

SponsorCancer Center of Irvine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-09

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