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

Primary Purpose

Prostatic Cancer

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Hyaluronic acid
Sponsored by
Anders Widmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Cancer focused on measuring Prostatic cancer, Radiotherapy, Hyaluronic acid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of oncology, Kalmar Hospital
  • Department of oncilogy, Sundsvall Hospital
  • Department of oncology, University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyaluronic acid

Arm Description

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

Outcomes

Primary Outcome Measures

Remaining volume of HA
Measurement on the remaining volume of HA by MRI

Secondary Outcome Measures

Quality of life
Patient evaluation with questionnaires regarding Quality of Life and side effects after radiotherapy

Full Information

First Posted
February 6, 2013
Last Updated
November 3, 2016
Sponsor
Anders Widmark
Collaborators
University Hospital, Umeå
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1. Study Identification

Unique Protocol Identification Number
NCT01787630
Brief Title
To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy
Acronym
NoHarm
Official Title
Initiating Phase II-III Study to Evaluate the Technique and Effects of Separating the Prostate From the Rectum With Hyaluronic Acid During Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anders Widmark
Collaborators
University Hospital, Umeå

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Cancer
Keywords
Prostatic cancer, Radiotherapy, Hyaluronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid
Arm Type
Experimental
Arm Description
Hyaluronic acid will be injected in the space between the prostate and rectum prior to radiotherapy to perform a dorsal movement of rectum.
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid
Other Intervention Name(s)
NASHA Spacer Gel
Intervention Description
Injection in connection with ultrasound
Primary Outcome Measure Information:
Title
Remaining volume of HA
Description
Measurement on the remaining volume of HA by MRI
Time Frame
24 month after end of radiotherapy
Secondary Outcome Measure Information:
Title
Quality of life
Description
Patient evaluation with questionnaires regarding Quality of Life and side effects after radiotherapy
Time Frame
24 month after end of radiotherapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Widmark, Prof MD
Organizational Affiliation
Umea university, dept of oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of oncology, Kalmar Hospital
City
Kalmar
ZIP/Postal Code
SE-39244
Country
Sweden
Facility Name
Department of oncilogy, Sundsvall Hospital
City
Sundsvall
ZIP/Postal Code
SE-851 86
Country
Sweden
Facility Name
Department of oncology, University Hospital
City
Umeå
ZIP/Postal Code
SE-901 85
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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