Recuitment target for patient enrollment was not met.
"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"
Sponsor study identifier
Secondary identifiers
OTHER · EBG MedAustron GmbH
interventional
5
1 country
1
Study Start
July 3, 2018
Actual (reported)Primary Completion
March 14, 2025
Actual (reported)Study Completion
March 14, 2025
Actual (reported)This prospective study assess the effectiveness and safety of hypofractionated proton radiotherapy in the treatment of intermediate and low risk prostate cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 14, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 3, 2018
Actual (reported)July 9, 2018
Actual (reported)November 14, 2018
Actual (reported)March 14, 2025
Actual (reported)March 14, 2025
Actual (reported)freedom from biochemical failure
Freedom from biochemical failure outcomes (FFBF) following spot-scanning based, moderately hypofractionated proton therapy will be compared with results of published studies using either similar or standard dose fractionation treatment regimen and using either photon or proton therapy. Determination of e.g., PSA, IPSS, Adverse Events
5 years
Determination of the intra-fraction target movement using planar kilovoltage (kV) x-ray Imaging 5x/week or at each day of ion therapy.
daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment)
Determination of the inter-fraction target and organ at risk movement using Conebeam CT 5x/week or at each day of ion therapy.
daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment)
Determination of the incidence of gastrointestinal and genitourinary toxicities acute during treatment
weekly through treatment completion, Months 3(±1)
Determination of the incidence of gastrointestinal and genitourinary toxicities late at 2 years
Months 24(±2)
Determination of the incidence of gastrointestinal and genitourinary toxicities late at 5 years
Months 60(±4)
Patients with low and intermediate risk are included. The following interventions are performed: * 'Expanded Prostate Cancer Index Composite' (EPIC) questionnaire * kV x-ray images * Conebeam CT
The EPIC questionnaire is used to evaluated the Quality of life of the patients including the sexual function.
After the applied daily fraction, x-ray imaging will be repeated daily to assess for intra-fraction motion of the prostate.
EBG MedAustron GmbH
Wiener Neustadt, Lower Austria, 2700, Austria
Carola Lütgendorf-Caucig, MD MPH MBA
EBG MedAustron GmbH
5 participants (actual enrollment reported by the registry).
First Submitted
July 9, 2018
First Posted
November 14, 2018
Study Start
July 3, 2018
Actual (reported)Primary Completion
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
March 14, 2025
Actual (reported)Study Completion
March 14, 2025
Actual (reported)Last Updated
May 11, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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