Experiences With HDR-brachytherapy in Norway

NCT ID: NCT03162523

Last Updated: 2017-05-25

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

COMPLETED

Total Enrollment

325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2016-10-15

Brief Summary

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There are 3 articles that will be written about the experience with HDR-brachytherapy (HDR-BT) in patients with high-risk prostate cancer in Norway as part of a doctorial thesis-project. The project will focus on survival, side-effects and dosimetry variables as the main points of interest.

Detailed Description

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First article will compare overall and prostate cancer specific-mortality in patients who has received HDR-BT compared to patients who has received external beam radiation therapy only (EBRT). Patients who have been treated with HDR-BT have been enrolled in an approved registry at Oslo University Hospital since 2004. The control group (EBRT only) data are from the Lancet published hallmark study SPCG-7 (Scandinavian Prostate Cancer Group). This is a case-control study.

Second article will focus on side-effects of HDR-BT compared to EBRT patients. Patients included in the registry described above have been sent (and completed with a 72% answer rate) a questionnaire of the standard Expanded Prostate Cancer Index (EPIC-26) form. This will be compared to patients who already have answered the same questionnaire in a previously published study (approved by the Norwegian Ethical Committee).

The Third article will investigate if there are any association between patients reporting severe adverse effects after HDR-BT and the patients dosimetry reports (i.e are there a larger dose to the urethra or rectum in these patients?)

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Scandinavian Prostate Cancer Group (SPCG), study number 7

Patients included in hallmark study of SPCG-7 receiving EBRT to 70 Gy in combination with lifelong anti-androgen treatment

High-Dose Rate Brachytherapy

Intervention Type RADIATION

Norwegian Urologic Cancer Group (NUCG) study number 7

Patients receiving EBRT to 74 Gy in combination with hormonal therapy. Approved by ethical comittee. Questionnaires already been completed during a different study (NUCG-7). These patients will therefore not be contacted again.

High-Dose Rate Brachytherapy

Intervention Type RADIATION

Interventions

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High-Dose Rate Brachytherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* age, high-risk prostate cancer, general good Health, anatomical favourable condition for brachytherapy

Exclusion Criteria

* poor Health, metastasis, T3b stage tumour, Prostate Specific Antigen (PSA) Levels \> 75, biological age \> 75 years
Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Trude Baastad Wedde

Consultant oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Trude Wedde, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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677905

Identifier Type: -

Identifier Source: org_study_id

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