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Protection of Rectum From High Radiation Doses Using a Spacer

NCT ID: NCT01918605

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site

Keywords

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prostate cancer brachytherapy spacer side effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Diluted spacer

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

Group Type EXPERIMENTAL

Diluted spacer

Intervention Type DEVICE

Non-diluted spacer

Single dose of DuraSeal product injected between rectum and prostate

Group Type ACTIVE_COMPARATOR

Non-diluted spacer

Intervention Type DEVICE

Interventions

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Diluted spacer

Intervention Type DEVICE

Non-diluted spacer

Intervention Type DEVICE

Other Intervention Names

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DuraSeal DuraSeal

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* not willing to participate this study
Minimum Eligible Age

50 Years

Maximum Eligible Age

78 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Markku Vaarala, MD, PhD

Associate Chief Urologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markku Vaarala, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Merja Korpela, MD

Role: STUDY_CHAIR

Oulu University Hospital

Vesa-Pekka Heikkilä, PhL

Role: STUDY_CHAIR

Oulu University Hospital

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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OY-111

Identifier Type: -

Identifier Source: org_study_id