To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy
- Conditions
- Prostatic Cancer
- Registration Number
- NCT01787630
- Lead Sponsor
- Anders Widmark
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 81
- Histologically verified prostatic cancer
- Low or intermediate risk prostatic cancer
- Lymph node negative
- Suitable for radiotherapy
- Earlier treatment for prostatic cancer
- Unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Remaining volume of HA 24 month after end of radiotherapy Measurement on the remaining volume of HA by MRI
- Secondary Outcome Measures
Name Time Method Quality of life 24 month after end of radiotherapy Patient evaluation with questionnaires regarding Quality of Life and side effects after radiotherapy
Trial Locations
- Locations (3)
Department of oncology, Kalmar Hospital
🇸🇪Kalmar, Sweden
Department of oncilogy, Sundsvall Hospital
🇸🇪Sundsvall, Sweden
Department of oncology, University Hospital
🇸🇪Umeå, Sweden
Department of oncology, Kalmar Hospital🇸🇪Kalmar, Sweden