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Experiences With HDR-brachytherapy in Norway

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ClinicalTrials.gov Identifier: NCT03162523
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : May 25, 2017
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Trude Baastad Wedde, Oslo University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Radiation: High-Dose Rate Brachytherapy

Detailed Description:

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?)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 325 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: Norwegian Experiences With Interstitial Radiation Treatment (Brachytherapy) for Men With High-risk Localised Prostate Cancer
Actual Study Start Date : January 2004
Actual Primary Completion Date : October 15, 2016
Actual Study Completion Date : October 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
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
Radiation: High-Dose Rate Brachytherapy
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.
Radiation: High-Dose Rate Brachytherapy



Primary Outcome Measures :
  1. Overall- and Prostate-Cancer specific mortality in patients treated with HDR-BT compared to EBRT alone [ Time Frame: 24 weeks ]
    The final measured outcome is death by prostate cancer, death due to other cause (overall mortality) or alive at 10 years.

  2. Patient-reported side-effects after HDR-BT compared to conventional EBRT [ Time Frame: 1 year ]
    Patient self-reported side-effects focusing on rectal, bladder, quality of life, sexual function and psycological bother will be recorded in both Groups and compared.

  3. Are there an Association between rectal dosage after HDR-BT and self-reported rectal bother in patients undergone HDR-BT treatment ? [ Time Frame: 2 years ]
    Investigations into needle placement, dosage and anatomical variations will be examined in patients who report rectal problems 5 years after HDR-BT treatment.



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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men are included from the south-east area of Norway and for control Groups from the entire country so that the study population is generalised.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162523


Locations
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Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
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Principal Investigator: Trude Wedde, MD Oslo University Hospital
Additional Information:

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Responsible Party: Trude Baastad Wedde, Consultant oncologist, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03162523    
Other Study ID Numbers: 677905
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases