Trials / Terminated
TerminatedNCT03740191
Spot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer
"Spot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer" "Hypofraktionierte Protonentherapie Mit Spot-Scanning-Technik Bei Prostatakarzinom Mit Niedrigem Oder Mittlerem Risiko"
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- EBG MedAustron GmbH · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This prospective study assess the effectiveness and safety of hypofractionated proton radiotherapy in the treatment of intermediate and low risk prostate cancer.
Detailed description
The purpose of this study is to assess the effectiveness and safety of spot-scanning based hypofractionated proton radiotherapy for the treatment of intermediate and low risk prostate cancer. The treatment effectiveness is defined as freedom from biochemical failure. Treatment safety will be documented with acute and late morbidity assessments. Dose volume relationships for late side effects in organs at risk surrounding the prostate will be calculated from the dose volume histogram parameters assessed during treatment planning. Patient assessed Quality of life data including sexual function will be collected to increase our understanding how the reduction of normal tissue irradiation with proton therapy with subsequent decrease in functional impairments will overall affect the patient's life.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | EPIC questionnaire | The EPIC questionnaire is used to evaluated the Quality of life of the patients including the sexual function. |
| RADIATION | kV x-ray images | After the applied daily fraction, x-ray imaging will be repeated daily to assess for intra-fraction motion of the prostate. |
| RADIATION | Conebeam CT | For the assessment of interfraction target and organs at risk movement. Conebeam CT as soon as it becomes available will be performed 5 x/week or at each day of proton therapy before treatment application. |
Timeline
- Start date
- 2018-07-03
- Primary completion
- 2025-03-14
- Completion
- 2025-03-14
- First posted
- 2018-11-14
- Last updated
- 2025-05-11
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT03740191. Inclusion in this directory is not an endorsement.