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.
|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|
- Mean rectal dose 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 ]
- 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 ]
|Study Start Date:||September 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
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
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.
|United States, California|
|Cancer Center of Irvine|
|Irvine, California, United States, 92618|
|Principal Investigator:||Kenneth M Tokita, MD||Cancer Center of Irvine|
|Study Director:||Richard B Wilder, MD||Cancer Center of Irvine|