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Trial Title:
To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy
NCT ID:
NCT01787630
Condition:
Prostatic Cancer
Conditions: Official terms:
Prostatic Neoplasms
Hyaluronic Acid
Conditions: Keywords:
Prostatic cancer
Radiotherapy
Hyaluronic acid
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Hyaluronic acid
Description:
Injection in connection with ultrasound
Arm group label:
Hyaluronic acid
Other name:
NASHA Spacer Gel
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:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of oncology, Kalmar Hospital
Address:
City:
Kalmar
Zip:
SE-39244
Country:
Sweden
Facility:
Name:
Department of oncilogy, Sundsvall Hospital
Address:
City:
Sundsvall
Zip:
SE-851 86
Country:
Sweden
Facility:
Name:
Department of oncology, University Hospital
Address:
City:
Umeå
Zip:
SE-901 85
Country:
Sweden
Start date:
January 2010
Completion date:
March 2021
Lead sponsor:
Agency:
Anders Widmark
Agency class:
Other
Collaborator:
Agency:
University Hospital, Umeå
Agency class:
Other
Source:
Umeå University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01787630
