NCT02761889Befejeződött
Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 12.
Rövid összefoglaló (regiszter, angolul)
The present study evaluates the safety, feasibility, quality-of-life effects, PSA kinetics, and clinical outcomes of definitive dose-escalated external beam radiotherapy for localized adenocarcinoma of the prostate. Eligible patients will have biopsy-proven localized prostate adenocarcinoma without radiographic evidence of regional or distant metastases and without MRI evidence of radiographic T3/T4 disease. Patients may have low-risk, intermediate-risk, or selected high-risk disease. Previous or concomitant hormonal therapy is allowed but is not required, provided prior hormonal therapy was not given for more than 6 months before protocol therapy. Patients enrolled in the study will receive image-guided volumetric modulated arc radiotherapy (IGRT-VMAT) to 45 Gy in five fractions of 9 Gy each, delivered on five consecutive treatment days unless a clinically or operationally justified interruption is required. Treatment will use organ-motion mitigation, urethral localization, online target tracking, urethral sparing, and treatment-planning quality assurance procedures designed to support normal tissue sparing and accurate radiation delivery. A rectal balloon with air filling will be used for prostate immobilization and anatomical reproducibility, and a urethral catheter loaded with beacon transponders will be used for set-up reproducibility and online tracking. Patients will be followed at approximately 1 month after treatment, then at approximately 3, 6, 9, and 12 months, and every 6 months thereafter through 60 months. Patients will be followed for a minimum of 5 years. Follow-up assessments will include physician-graded gastrointestinal and genitourinary toxicity using NCI CTCAE v4.0, patient-reported urinary, bowel, and sexual quality-of-life outcomes using validated instruments including EPIC, IPSS, and IIEF questionnaires, and serum PSA testing. Biochemical relapse-free survival will be assessed using the Phoenix definition, and recurrence patterns will be summarized from clinically indicated imaging.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 444 (tényleges)
- Első benyújtás
- 2016. ápr. 26.
- Kezdés
- 2013. máj. 1.
- Elsődleges befejezés
- 2025. dec. 30.
- Fő szponzor
- Fundacao Champalimaud
- Betegségek
- Prosztatarák
- NCT-szám
- NCT02761889
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 444
- 2013. máj. 1. és az elsődleges befejezés (2025. dec. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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- Participants must meet all of the following criteria:
- Signed study-specific informed consent.
- Histologic confirmation of adenocarcinoma of the prostate by biopsy.
- Localized low-risk, intermediate-risk, or selected high-risk adenocarcinoma of the prostate. Selected high-risk disease is limited to patients with no MRI evidence of radiographic T3/T4 disease and no radiographic regional or distant metastases.
- No direct evidence of regional or distant metastases after appropriate staging studies.
- Previous or concomitant hormonal therapy is allowed but not required. - Previous hormonal therapy must not have been given for more than 6 months before protocol therapy.
- Age ≥40 years.
- Performance status 0-2.
- IPSS score ≤20; alpha blockers are allowed.
- CT- or ultrasound-based prostate volume estimate ≤150 grams.
- Participants meeting any of the following criteria are ineligible:
- Metastatic prostate cancer on imaging studies.
- MRI evidence of radiographic T3 or T4 disease.
- Previous pelvic radiotherapy.
- Previous surgery for prostate cancer.
- Previous hormonal therapy given for more than 6 months before protocol therapy.
- History of Crohn's disease or ulcerative colitis.
- Significant obstructive urinary symptoms, defined as IPSS >20.
- Significant psychiatric illness that would interfere with protocol participation.
- Severe active comorbidity that, in the investigator's judgment, would preclude safe protocol therapy or required follow-up.
Életkor a regiszterben: 40 év – - · Nem: csak férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
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| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Champalimaud Foundation | Lisbon | Portugália | Ismeretlen állapot |
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