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

NCT00882232 | Completed Phase 1 DMC

• 2 other identifiers: G080064S002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate; cancer; cross-linked; hyaluronan; gel; Hylaform; rectal; toxicity

Outcome Measures

Primary Outcomes (1)

• Mean rectal dose without Hylaform vs with Hylaform

  8 months

Secondary Outcomes (3)

• Severity of late diarrhea without Hylaform vs with Hylaform

  33 months

• Rectal wall relative V60 and V70 without Hylaform vs with Hylaform

  8 months

• Severity of acute diarrhea during IMRT without Hylaform vs with Hylaform

  8 months

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

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.

Also known as: Hylaform

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Center of Irvine: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Cancer Center of Irvine

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kenneth M Tokita, MD

  Cancer Center of Irvine

  PRINCIPAL INVESTIGATOR

• Richard B Wilder, MD

  Cancer Center of Irvine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

US (1)