Trial Information
Initiating Phase II-III Study to Evaluate the Technique and Effects of Separating the Prostate From the Rectum With Hyaluronic Acid During Radiotherapy
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Remaining volume of HA
Outcome Description:
Measurement on the remaining volume of HA by MRI
Outcome Time Frame:
24 month after end of radiotherapy
Safety Issue:
Yes
Principal Investigator
Anders Widmark, Prof MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Umea university, dept of oncology
Authority:
Sweden: Medical Products Agency
Study ID:
NoHarm1
NCT ID:
NCT01787630
Start Date:
January 2010
Completion Date:
December 2014
Related Keywords:
- Prostatic Cancer
- Prostatic cancer
- Radiotherapy
- Hyaluronic acid
- Prostatic Neoplasms