Protection of Rectum From High Radiation Doses Using a Spacer

University of Oulu

Status: Terminated

Conditions: Neoplasms by Site; Urogenital Neoplasms; Genital Neoplasms, Male; Prostatic Neoplasms

Treatments: Device: Non-diluted spacer; Device: Diluted spacer

Study type: Interventional

Funder types: Other

Identifiers

NCT01918605

OY-111

Details and patient eligibility

About

The purpose of this study is to evaluate the usefulness of diluted and non-diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy.

Full description

Radiation therapy for prostate cancer leads to inappropriate radiation dose to the rectum wall leading rectum adverse effects in long term for some patients. A resorbable spaces between prostate and rectum could decrease the incidence of these side effect. In this trial, men with prostate cancer with intention to curative treatment by low-dose brachytherapy will be recruited. The subjects will be randomized to receive either diluted or non-diluted DuraSeal product as a spacer between prostate and rectum. Diluted or non-diluted DuraSeal will be applied between rectum and prostate at the end of the brachytherapy seed implantation procedure. After the implantation of the brachytherapy seeds, a needle is placed between rectum and prostate through perineal skin under transrectal ultrasound guidance. The proper position of the needle is confirmed by the injection of 10-15 ml sterile saline solution. After that, DuraSeal components are diluted in 1:1 with sterile saline and 6-10 ml of this diluted product will be injected using DuraSeal applicator. If the subject is randomized to receive non-diluted DuraSeal, the procedure will be identical with the exception the DuraSeal components will not be diluted. The resolution of the spacer will be followed by repeated plain computer tomography (CT) of pelvis performed a day before operation, a day after the operation, and 4, 8 and 12 weeks after the operation. In addition, magnetic resonance imaging of pelvis performed 12 weeks after the operation. The space created between prostate and rectum will be documented by plain CT and magnetic resonance imaging. Rectum radiation dose will be calculated based on these scans. Time to DuraSeal resolution will be evaluated from the scans. Possible side effects will be collected by subject interviews during follow-up visits at 4, 8 and 12 weeks after the operation.

Enrollment: 5 patients

Sex: Male

Ages: 50 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• prostate cancer patients with planned low-dose brachytherapy for the treatment of prostate cancer

Exclusion criteria

• not willing to participate this study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

5 participants in 2 patient groups

Diluted spacer

Experimental group

Description:

Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate

Treatment:

Device: Diluted spacer

Non-diluted spacer

Active Comparator group

Description:

Single dose of DuraSeal product injected between rectum and prostate

Treatment:

Device: Non-diluted spacer