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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

Tracking Information
First Submitted Date May 7, 2017
First Posted Date May 22, 2017
Last Update Posted Date May 25, 2017
Actual Study Start Date January 2004
Actual Primary Completion Date October 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 19, 2017)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Experiences With HDR-brachytherapy in Norway
Official Title Norwegian Experiences With Interstitial Radiation Treatment (Brachytherapy) for Men With High-risk Localised Prostate Cancer
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.
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?)

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
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.
Condition Prostate Cancer
Intervention Radiation: High-Dose Rate Brachytherapy
Study Groups/Cohorts
  • 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
    Intervention: 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.
    Intervention: Radiation: High-Dose Rate Brachytherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 19, 2017)
325
Original Actual Enrollment Same as current
Actual Study Completion Date October 15, 2016
Actual Primary Completion Date October 15, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages up to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03162523
Other Study ID Numbers 677905
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Trude Baastad Wedde, Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators University of Oslo
Investigators
Principal Investigator: Trude Wedde, MD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date May 2017