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

NCT ID: NCT00882232

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-09-30

Brief 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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cross-linked hyaluronan gel

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Hylaform

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Cancer Center of Irvine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth M Tokita, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Center of Irvine

Richard B Wilder, MD

Role: STUDY_DIRECTOR

Cancer Center of Irvine

Locations

Cancer Center of Irvine

Irvine, California, United States

Countries

United States

Other Identifiers

S002

Identifier Type: -

Identifier Source: secondary_id

G080064

Identifier Type: -

Identifier Source: org_study_id