Experiences With HDR-brachytherapy in Norway

Oslo University Hospital325 enrolled

Overview

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.

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

Enrollment

325

Conditions

Prostate Cancer

Interventions

High-Dose Rate BrachytherapyRADIATION

Eligibility

Sex: MALEMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Oslo University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 2 years

Data from ClinicalTrials.gov

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