1. freedom from biochemical failure (Time Frame - 5 years): 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
Secondary outcome:
1. Determination of the intra-fraction target movement using planar kilovoltage (kV) x-ray Imaging 5x/week or at each day of ion therapy. (Time Frame - daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment))
2. Determination of the inter-fraction target and organ at risk movement using Conebeam CT 5x/week or at each day of ion therapy. (Time Frame - daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment))
3. Determination of the incidence of gastrointestinal and genitourinary toxicities acute during treatment (Time Frame - weekly through treatment completion, Months 3(±1))
4. Determination of the incidence of gastrointestinal and genitourinary toxicities late at 2 years (Time Frame - Months 24(±2))
5. Determination of the incidence of gastrointestinal and genitourinary toxicities late at 5 years (Time Frame - Months 60(±4))
6. Assessment of the quality of life and sexual function following proton therapy. (Time Frame - Baseline, Months 3(±1), 6(±2), 12(±2), 18(±2), 24(±2), 36(±4), 48(±4), 60(±4)): Change of quality of life and sexual function from Baseline following proton therapy. The Prostate cancer-specific Health-Related Quality of Life questionnaire Expanded Prostate Index Composite (EPIC-26) will be used. EPIC is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. EPIC-26 was developed as a short-form version of the full EPIC. This version contains 26 item and the same 5 domains as the full version of EPIC: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better quality of life.
7. Correlation of adverse events (toxicity), quality of life (QoL) and sexual function with dosevolume histogram parameters adjusted according to actual dose delivered. (Time Frame - Dose volume histogram parameters: Pre-Treatment, Toxicity: Weekly during proton therapy, Months 3(±1), 6(±2), 12(±2), 18(±2), 24(±2), 36(±4), 48(±4), 60(±4), Quality of life: Pre-Treatment, Months 3(±1), 6(±2), 12(±2), 18(±2), 24(±2), 36(±4)): Correlation of adverse events (toxicity) (see Determination of the incidence of gastrointestinal and genitourinary toxicities), quality of life (QoL) and sexual function (see Assessment of the quality of life and sexual function) with dosevolume histogram parameters adjusted according to actual dose delivered.
8. Determine disease specific survival at 5 years. (Time Frame - 5 years)
9. Determine overall survival at 5 years. (Time Frame - 5 years)
10. Determination of the intra- and inter- mobility of prostate, seminal vesicles and rectum in order to further define and refine planning target volume parameters for future applications. (Time Frame - daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment)): Determination of the intra- and inter- mobility of prostate, seminal vesicles and rectum in order to further define and refine planning target volume parameters for future applications by using data assessed by determination of the intra-fraction target movement using planar kV x-ray imaging 5x/week or at each day of ion therapy (see Determination of the intra-fraction target movement using planar kilovoltage (kV) x-ray Imaging 5x/week or at each day of ion therapy) and determination of the inter-fraction target and organ at risk movement using Conebeam CT (see Determination of the inter-fraction target and organ at risk movement using Conebeam CT 5x/week or at each day of ion therapy).
EPIC questionnaire: The EPIC questionnaire is used to evaluated the Quality of life of the patients including the sexual function.
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.
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.
Quelle: ClinicalTrials.gov
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"Spot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer"
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