Clinical trial NCT00882232: Cross-linked Hyaluronan Gel Reduces Rectal Toxicity Due to Radiation Therapy for Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: prostate
cancer
cross-linked
hyaluronan
gel
Hylaform
rectal
toxicity
Lead sponsor: Cancer Center of Irvine
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2009-04-16
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean rectal dose without Hylaform vs with Hylaform
timeFrame: 8 months
Secondary outcomes:
measure: Severity of late diarrhea without Hylaform vs with Hylaform
timeFrame: 33 months
measure: Rectal wall relative V60 and V70 without Hylaform vs with Hylaform
timeFrame: 8 months
measure: Severity of acute diarrhea during IMRT without Hylaform vs with Hylaform
timeFrame: 8 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Cancer Center of Irvine
state: California
Study officials:
affiliation: Cancer Center of Irvine
name: Kenneth M Tokita, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Center of Irvine
name: Richard B Wilder, MD
role: STUDY_DIRECTOR
References: