Clinical trial · Interventional
To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy
Initiating Phase II-III Study to Evaluate the Technique and Effects of Separating the Prostate From the Rectum With Hyaluronic Acid During Radiotherapy
- 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 dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.
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 |
|---|---|---|---|
| Prostatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyaluronic acid | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyaluronic acid
- description
- Hyaluronic acid will be injected in the space between the prostate and rectum prior to radiotherapy to perform a dorsal movement of rectum.
- interventionNames
- Device: Hyaluronic acid
Primary outcomes (1)
- measure
- Remaining volume of HA
- timeFrame
- 24 month after end of radiotherapy
- description
- Measurement on the remaining volume of HA by MRI
Secondary outcomes (1)
- measure
- Quality of life
- timeFrame
- 24 month after end of radiotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified prostatic cancer * Low or intermediate risk prostatic cancer * Lymph node negative * Suitable for radiotherapy Exclusion Criteria: * Earlier treatment for prostatic cancer * Unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment
References
Publications (0)
Data not yet available