Prostate Cancer
Conditions
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?)
Interventions
RADIATIONHigh-Dose Rate Brachytherapy
Sponsors
University of Oslo
Oslo University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
MALE
Age
No minimum to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall- and Prostate-Cancer specific mortality in patients treated with HDR-BT compared to EBRT alone | 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 | 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 ? | 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. |
Countries
Norway
Outcome results
None listed