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Space OAR™-pilot observational study - implementation in clinical practice

Space OAR™-pilot observational study - implementation in clinical practice - Space OAR™- pilot observational study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00003273
Enrollment
50
Registered
2011-09-27
Start date
2011-10-10
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: Patients with hydrogel injection before radiation treatment of low/intermediate risk prostae cancer are interviewed with questionaires in the first ten years after radiotherapy.

Sponsors

Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Routine application of Space OAR™ before radiation treatment 2. age of at least 18 years 3. unimpaired consciousness 4. ability to understand questionnaires 5. follow-uo at the institution

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Acute and chronic toxicity is measured weekly during radiotherapy and after three months. Therafter, patients are interviewed with questionaires annually. The questionaires evaluate toxicity regarding bladder, rectum, continence, potency and quality of life according to CTC or RTOG criteria and the quality of life questionaire of DKG (QoL, health status, continence score, potency score).

Secondary

MeasureTime frame
Radiation dose calculation of organs at risk in Gy for correlation with resulting side effects.

Countries

Germany

Contacts

Public ContactSilke Theden

Universitätsklinik für Radioonkologie

silke.theden@med.uni-tuebingen.de07071-2983420

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 24, 2026