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To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy
Conditions
Prostatic Cancer
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
Prostatic cancer, Radiotherapy, Hyaluronic acid
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Hyaluronic acid
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Male
Criteria: 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
- 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
Locations
Department of oncology, Kalmar Hospital
Kalmar, Sweden
Department of oncilogy, Sundsvall Hospital
Status: Recruiting
Contact: Magnus Lagerlund, MD - magnus.lagerlund@ltkalmar.se
Sundsvall, Sweden
Department of oncology, University Hospital
Status: Not yet recruiting
Umeå, Sweden
Status: Recruiting
Contact: Anders Widmark, MD - anders.widmark@onkologi.umu.se
Start Date
January 2010
Completion Date
December 2014
Sponsors
Anders Widmark
Source
Umeå University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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