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

A

Anders Widmark

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Prostatic Cancer

Treatments

Device: Hyaluronic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01787630
NoHarm1

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

81 participants in 1 patient group

Hyaluronic acid
Experimental group
Description:
Hyaluronic acid will be injected in the space between the prostate and rectum prior to radiotherapy to perform a dorsal movement of rectum.
Treatment:
Device: Hyaluronic acid

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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