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To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy

NCT ID: NCT01787630

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2021-03-31

Brief Summary

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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

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Conditions

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Prostatic Cancer

Keywords

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Prostatic cancer Radiotherapy Hyaluronic acid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyaluronic acid

Hyaluronic acid will be injected in the space between the prostate and rectum prior to radiotherapy to perform a dorsal movement of rectum.

Group Type EXPERIMENTAL

Hyaluronic acid

Intervention Type DEVICE

Injection in connection with ultrasound

Interventions

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Hyaluronic acid

Injection in connection with ultrasound

Intervention Type DEVICE

Other Intervention Names

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NASHA Spacer Gel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Umeå

OTHER

Sponsor Role collaborator

Anders Widmark

OTHER

Sponsor Role lead

Responsible Party

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Anders Widmark

Professor, MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anders Widmark, Prof MD

Role: PRINCIPAL_INVESTIGATOR

Umea university, dept of oncology

Locations

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Department of oncology, Kalmar Hospital

Kalmar, , Sweden

Site Status

Department of oncilogy, Sundsvall Hospital

Sundsvall, , Sweden

Site Status

Department of oncology, University Hospital

Umeå, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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NoHarm1

Identifier Type: -

Identifier Source: org_study_id