Experiences With HDR-brachytherapy in Norway
Norwegian Experiences With Interstitial Radiation Treatment (Brachytherapy) for Men With High-risk Localised Prostate Cancer
1 other identifier
observational
325
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2016
CompletedFirst Submitted
Initial submission to the registry
May 7, 2017
CompletedFirst Posted
Study publicly available on registry
May 22, 2017
CompletedMay 25, 2017
May 1, 2017
12.8 years
May 7, 2017
May 23, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Overall- and Prostate-Cancer specific mortality in patients treated with HDR-BT compared to EBRT alone
The final measured outcome is death by prostate cancer, death due to other cause (overall mortality) or alive at 10 years.
24 weeks
Patient-reported side-effects after HDR-BT compared to conventional EBRT
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.
1 year
Are there an Association between rectal dosage after HDR-BT and self-reported rectal bother in patients undergone HDR-BT treatment ?
Investigations into needle placement, dosage and anatomical variations will be examined in patients who report rectal problems 5 years after HDR-BT treatment.
2 years
Study Arms (2)
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
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- age, high-risk prostate cancer, general good Health, anatomical favourable condition for brachytherapy
You may not qualify if:
- poor Health, metastasis, T3b stage tumour, Prostate Specific Antigen (PSA) Levels \> 75, biological age \> 75 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- University of Oslocollaborator
Study Sites (1)
Oslo University Hospital
Oslo, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Trude Wedde, MD
Oslo University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant oncologist
Study Record Dates
First Submitted
May 7, 2017
First Posted
May 22, 2017
Study Start
January 1, 2004
Primary Completion
October 15, 2016
Study Completion
October 15, 2016
Last Updated
May 25, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share