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

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)

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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