Experiences With HDR-brachytherapy in Norway

Study Overview
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Brief Summary
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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
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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?)

Official Title
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Norwegian Experiences With Interstitial Radiation Treatment (Brachytherapy) for Men With High-risk Localised Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: High-Dose Rate Brachytherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Scandinavian Prostate Cancer Group (SPCG), study number 7<br>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<br> <br> |
| Norwegian Urologic Cancer Group (NUCG) study number 7<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |