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
18 Years
N/A
Male
Prostate Cancer
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Mean rectal dose without Hylaform vs with Hylaform
Outcome Time Frame:
8 months
Safety Issue:
Yes
Principal Investigator
Kenneth M Tokita, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Center of Irvine
Authority:
United States: Food and Drug Administration
Study ID:
G080064
NCT ID:
NCT00882232
Start Date:
September 2008
Completion Date:
September 2009
Related Keywords:
- Prostate Cancer
- prostate
- cancer
- cross-linked
- hyaluronan
- gel
- Hylaform
- rectal
- toxicity
- Prostatic Neoplasms
Name | Location |
|---|---|
| Cancer Center of Irvine | Irvine, California 92618 |
