TERMINATEDNA

Protection of Rectum From High Radiation Doses Using a Spacer

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.

Sponsor

University of Oulu

Enrollment

5 participants

Sites

1 locations

Start Date

June 2013

Completion

October 2017

Prostatic NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteDiluted spacer

Enrollment & Timeline

Terminated

Target N

participants

Sites

locations

Duration

4.3 years

total trial span

Jun 2013Month 154 of 52Oct 2017

100% of trial timeline elapsed

View on ClinicalTrials.gov

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Primary Outcomes

Change in spacer volume

1 day, 4 weeks, 8 weeks, 12 weeks

Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 12 weeks after the operation in order to confirm the extent of spacer.

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

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Fetching protocol from ClinicalTrials.gov…

TERMINATEDNA

Protection of Rectum From High Radiation Doses Using a Spacer

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.

Sponsor

University of Oulu

Enrollment

5 participants

Sites

1 locations

Start Date

June 2013

Completion

October 2017

Prostatic NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteDiluted spacer

Enrollment & Timeline

Terminated

Target N

participants

Sites

locations

Duration

4.3 years

total trial span

Jun 2013Month 154 of 52Oct 2017

100% of trial timeline elapsed

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Change in spacer volume

1 day, 4 weeks, 8 weeks, 12 weeks

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

50 Years

Max Age

78 Years

Sex

male

Healthy Volunteers

View full 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

Protection of Rectum From High Radiation Doses Using a Spacer

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Protection of Rectum From High Radiation Doses Using a Spacer

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)