Clinical trial NCT01918605: Protection of Rectum From High Radiation Doses Using a Spacer
Official title: Protection of Rectum From High Radiation Doses During Prostate Cancer Low-dose Brachytherapy Using Diluted or Non-diluted DuraSeal as a Spacer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Keywords: prostate cancer
brachytherapy
spacer
side effect
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2013-08-08
Enrollment: 5
Sex: MALE
Minimum age (years): 50
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* not willing to participate this study

Primary outcomes:
measure: Change in spacer volume
timeFrame: 1 day, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Side effects
timeFrame: 1 day, 4 weeks, 8 weeks, 12 weeks
measure: Rectum radiation dose
timeFrame: 1 day, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Markku Vaarala, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Merja Korpela, MD
role: STUDY_CHAIR
affiliation: Oulu University Hospital
name: Vesa-Pekka Heikkilä, PhL
role: STUDY_CHAIR
References: