Experiences With HDR-brachytherapy in Norway

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162523
• Other study ID #: 677905
• Status: Completed
• Phase: N/A
• First received: May 7, 2017
• Last updated: May 23, 2017
• Start date: January 2004
• Est. completion date: October 15, 2016

Study information

• Verified date: May 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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?)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: October 15, 2016
• Est. primary completion date: October 15, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• High-Dose Rate Brachytherapy

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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