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Completed

NCT Number: NCT00882232

Cross-linked Hyaluronan Gel Reduces Rectal Toxicity Due to 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Center of Irvine

Irvine, California, 92618, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cross-linked hyaluronan gel

Device

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 names: Hylaform

Primary outcomes

  1. Mean rectal dose without Hylaform vs with Hylaform

    Time frame: 8 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cancer Center of Irvine

Other

Collaborators

  • Genzyme, a Sanofi Company

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 16, 2009
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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