Prostatic Cancer
Conditions
Keywords
Prostatic cancer, Radiotherapy, Hyaluronic acid
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.
Interventions
DEVICEHyaluronic acid
Injection in connection with ultrasound
Sponsors
University Hospital, Umeå
Anders Widmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remaining volume of HA | 24 month after end of radiotherapy | Measurement on the remaining volume of HA by MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 24 month after end of radiotherapy | Patient evaluation with questionnaires regarding Quality of Life and side effects after radiotherapy |
Countries
Sweden
Outcome results
None listed