Trials / Unknown
UnknownNCT01787630
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
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- Anders Widmark · Academic / Other
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hyaluronic acid | Injection in connection with ultrasound |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2016-03-01
- Completion
- 2021-03-01
- First posted
- 2013-02-08
- Last updated
- 2016-11-04
Locations
3 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT01787630. Inclusion in this directory is not an endorsement.