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

Prostatic Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01787630
• Other study ID #: NoHarm1
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: February 6, 2013
• Last updated: November 3, 2016
• Start date: January 2010
• Est. completion date: March 2021

Study information

• Verified date: November 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: March 2021
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Cancer
• Prostatic Neoplasms

Intervention

Device:
• Hyaluronic acid
Injection in connection with ultrasound

Locations

Country	Name	City	State
Sweden	Department of oncology, Kalmar Hospital	Kalmar
Sweden	Department of oncilogy, Sundsvall Hospital	Sundsvall
Sweden	Department of oncology, University Hospital	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Anders Widmark	University Hospital, Umeå

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remaining volume of HA	Measurement on the remaining volume of HA by MRI	24 month after end of radiotherapy	Yes
Secondary	Quality of life	Patient evaluation with questionnaires regarding Quality of Life and side effects after radiotherapy	24 month after end of radiotherapy	No