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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


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

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