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

This study has been completed.
Sponsor:
Collaborator:
Genzyme
Information provided by (Responsible Party):
Cancer Center of Irvine
ClinicalTrials.gov Identifier:
NCT00882232
First received: April 15, 2009
Last updated: February 14, 2013
Last verified: February 2013
History of Changes

April 15, 2009
February 14, 2013
September 2008
September 2009   (final data collection date for primary outcome measure)
Mean rectal dose without Hylaform vs with Hylaform [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00882232 on ClinicalTrials.gov Archive Site
  • Severity of late diarrhea without Hylaform vs with Hylaform [ Time Frame: 33 months ] [ Designated as safety issue: Yes ]
  • Rectal wall relative V60 and V70 without Hylaform vs with Hylaform [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • Severity of acute diarrhea during IMRT without Hylaform vs with Hylaform [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
Severity of late diarrhea without Hylaform vs with Hylaform [ Time Frame: 33 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Cross-linked Hyaluronan Gel Reduces Rectal Toxicity Due to Radiation Therapy for Prostate Cancer
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

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.

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.
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
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
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.
Intervention: Device: Cross-linked hyaluronan gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00882232
G080064, S002
Yes
Cancer Center of Irvine
Cancer Center of Irvine
Genzyme
Principal Investigator: Kenneth M Tokita, MD Cancer Center of Irvine
Study Director: Richard B Wilder, MD Cancer Center of Irvine
Cancer Center of Irvine
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP