NCT02761889Completed
Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 444 (actual)
- First submitted
- 26 Apr 2016
- Start date
- 1 May 2013
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Fundacao Champalimaud
- Diseases
- Prostate cancer
- NCT number
- NCT02761889
What you commit to
- Study type: Interventional
- Participants enrolled: 444
- From 1 May 2013 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 40 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Champalimaud Foundation Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.