Clinical trial · Interventional
Cross-linked Hyaluronan Gel Reduces Rectal Toxicity Due to Radiation Therapy for Prostate Cancer
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
NCT00882232CI-TRIAL-00009463completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cross-linked hyaluronan gel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- 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.
- interventionNames
- Device: Cross-linked hyaluronan gel
Primary outcomes (1)
- measure
- Mean rectal dose without Hylaform vs with Hylaform
- timeFrame
- 8 months
Secondary outcomes (3)
- measure
- Severity of late diarrhea without Hylaform vs with Hylaform
- timeFrame
- 33 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.