Experiences With HDR-brachytherapy in Norway

University of Oslo (UIO)

Status: Completed

Conditions: Prostate Cancer

Treatments: Radiation: High-Dose Rate Brachytherapy

Study type: Observational

Funder types: Other

Identifiers

NCT03162523

677905

Details and patient eligibility

About

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.

Full 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?)

Enrollment: 325 patients

Sex: Male

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

325 participants in 2 patient groups

Scandinavian Prostate Cancer Group (SPCG), study number 7

Description:

Patients included in hallmark study of SPCG-7 receiving EBRT to 70 Gy in combination with lifelong anti-androgen treatment

Treatment:

Radiation: High-Dose Rate Brachytherapy

Norwegian Urologic Cancer Group (NUCG) study number 7

Description:

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.

Treatment:

Radiation: High-Dose Rate Brachytherapy