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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882232
• Other study ID #: G080064
• Secondary ID: S002
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2009
• Last updated: February 14, 2013
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: February 2013
• Source: Cancer Center of Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Cancer Center of Irvine	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Center of Irvine	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean rectal dose without Hylaform vs with Hylaform		8 months	Yes
Secondary	Severity of late diarrhea without Hylaform vs with Hylaform		33 months	Yes
Secondary	Rectal wall relative V60 and V70 without Hylaform vs with Hylaform		8 months	Yes
Secondary	Severity of acute diarrhea during IMRT without Hylaform vs with Hylaform		8 months	Yes

External Links

•   Cancer Center of Irvine