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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00882232
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : February 15, 2013
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Cancer Center of Irvine

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 cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Cross-linked hyaluronan gel Phase 1

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. Another possible risk (<5%) is an allergic reaction such as itching. Patients who are allergic to avian products will be excluded from the study. Tenderness and pain at the injection site are possible. Bleeding, bruising, redness, or discoloration or the formation of a bump (granuloma) or scar (keloid) at the injection site is also possible. Embolization of cross-linked hyaluronan gel through the blood is a potential, rare complication if the gel is injected into a blood vessel rather than into fat. Prada et al. did not see any side effects related to the injection or the material itself in 27 patients based on a mean follow-up of 13 months (range: 9-22 months). Patients did not complain of pain, tenesmus, rectal pressure, or a sensation of rectal filling. Risks beyond 22 months are not well defined. Potential benefits of cross-linked hyaluronan gel include fewer rectal complications due to radiotherapy for early-stage prostate cancer.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transperineal Injection of Cross-linked Hyaluronan Gel Into Anterior Perirectal Fat to Reduce Rectal Toxicity From High Dose Rate Brachytherapy and/or Intensity-Modulated Radiation Therapy for Prostate Cancer
Study Start Date : September 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: 1
Cross-linked hyaluronan gel and radiotherapy. Cross-linked hyaluronan gel is injected under anesthesia between the prostate and rectum prior to the start of radiotherapy. The gel pushes the prostate away from the rectum over several months, thereby reducing the dose of radiation delivered to the rectum. Hyaluronic acid is a naturally-occurring substance that is gradually absorbed by the body.
Device: Cross-linked hyaluronan gel
Single, transperitoneal injection of 9 mL cross-linked hyaluronan gel into anterior perirectal fat under anesthesia. The gel is injected prior to the start of radiotherapy and is absorbed by the body over several months. It increases the seapartion between the prostate and rectum by 1/3" to 2/3" at the start of radiotherapy.
Other Name: Hylaform

Primary Outcome Measures :
  1. Mean rectal dose without Hylaform vs with Hylaform [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Severity of late diarrhea without Hylaform vs with Hylaform [ Time Frame: 33 months ]
  2. Rectal wall relative V60 and V70 without Hylaform vs with Hylaform [ Time Frame: 8 months ]
  3. Severity of acute diarrhea during IMRT without Hylaform vs with Hylaform [ Time Frame: 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically-confirmed adenocarcinoma of the prostate, clinical stage T1c-T2c, NX, N0, M0.
  2. 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.
  3. Prostate cancer biopsy grading by Gleason score classification is mandatory.
  4. No prior pelvic radiotherapy. Induction hormonal therapy for less than or equal to 6 months is acceptable.
  5. Prostate volume by TRUS < 50 cc prior to HDR brachytherapy.
  6. Prostate specific antigen (PSA) less than or equal to 30 ng/ml.
  7. Patient has provided informed consent.

Exclusion Criteria:

  1. Clinical stage T3 or T4.
  2. Clinical evidence of lymph node involvement (N1).
  3. Clinical evidence of distant metastases (M1).
  4. Radical surgery for carcinoma of the prostate.
  5. Allergy to avian products.
  6. Significant mental, medical, or physical impairment.
  7. Prisoners.
  8. Employees of the Cancer Center of Irvine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00882232

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United States, California
Cancer Center of Irvine
Irvine, California, United States, 92618
Sponsors and Collaborators
Cancer Center of Irvine
Genzyme, a Sanofi Company
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Principal Investigator: Kenneth M Tokita, MD Cancer Center of Irvine
Study Director: Richard B Wilder, MD Cancer Center of Irvine
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Responsible Party: Cancer Center of Irvine Identifier: NCT00882232    
Other Study ID Numbers: G080064
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by Cancer Center of Irvine:
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents