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

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
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
  Purpose

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 Intervention Phase
Prostate Cancer
Device: Cross-linked hyaluronan gel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cancer Center of Irvine:

Primary Outcome Measures:
  • Mean rectal dose without Hylaform vs with Hylaform [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882232

Locations
United States, California
Cancer Center of Irvine
Irvine, California, United States, 92618
Sponsors and Collaborators
Cancer Center of Irvine
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Kenneth M Tokita, MD Cancer Center of Irvine
Study Director: Richard B Wilder, MD Cancer Center of Irvine
  More Information

Additional Information:
No publications provided

Responsible Party: Cancer Center of Irvine
ClinicalTrials.gov Identifier: NCT00882232     History of Changes
Other Study ID Numbers: G080064, S002
Study First Received: April 15, 2009
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cancer Center of Irvine:
prostate
cancer
cross-linked
hyaluronan
gel
Hylaform
rectal
toxicity

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014