Adenocarcinoma of the ProstateNCT02761889
Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer
A study testing Ultra-hypofractionated IGRT-VMAT with organ-motion mitigation and urethral sparing, Rectal balloon with air filling and Urethral catheter loaded with beacon transponders in people with Adenocarcinoma of the Prostate, run by Fundacao Champalimaud at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- Ultra-hypofractionated IGRT-VMAT with organ-motion mitigation and urethral sparing, Rectal balloon with air filling and Urethral catheter loaded with beacon transponders
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2013to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
This is a prospective, single-arm phase II study of definitive ultra-hypofractionated image-guided radiotherapy for localized prostate adenocarcinoma. The study is designed to evaluate the acute and late safety profile, feasibility, patient-reported quality-of-life outcomes, PSA kinetics, biochemical relapse-free survival, and clinical outcomes of dose-escalated IGRT-VMAT using organ-motion mitigation and urethral sparing.
Patients will receive 45 Gy in 5 fractions of 9 Gy each. Treatment planning will use CT/MRI-based target and organ-at-risk delineation. The protocol incorporates a rectal balloon for prostate stabilization and anatomical reproducibility, a urethral catheter loaded with beacon transponders for urethral localization and online motion tracking, and inverse dose-painting to reduce urethral dose when compatible with target coverage and disease anatomy. Erectile-related structures, including the neurovascular bundles, urogenital diaphragm, and penile bulb, may be contoured and recorded for quality-of-life and dosimetric analyses.
The primary safety assessments are treatment-related Grade 3 or higher gastrointestinal or genitourinary toxicity occurring from the first protocol fraction through 90 days after treatment completion, and treatment-related late Grade 2 or higher gastrointestinal or genitourinary toxicity occurring more than 90 days through 5 years after completion of radiotherapy. Late Grade 3 or higher gastrointestinal or genitourinary toxicity will be summarized separately. Clinically meaningful deterioration from baseline in urinary, bowel, and sexual patient-reported outcomes will be evaluated as a key safety and quality-of-life assessment.
Secondary assessments include PSA kinetics, biochemical relapse-free survival using the Phoenix definition, quality-of-life changes measured by EPIC, IPSS, and IIEF instruments, erectile and sexual function preservation, associations between clinical or dosimetric factors and outcomes, hormonal therapy exposure, and patterns of recurrence on clinically indicated imaging.
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- Ultra-hypofractionated IGRT-VMAT with organ-motion mitigation and urethral sparing, Rectal balloon with air filling, Urethral catheter loaded with beacon transponders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-hypofractionated IGRT-VMAT with organ-motion mitigation and urethral sparingRadiation
Image-guided volumetric modulated arc radiotherapy delivered to 45 Gy in 5 fractions of 9 Gy each. Treatment uses CT/MRI-based planning, a rectal balloon for target immobilization and anatomical reproducibility, a urethral catheter loaded with beacon transponders for localization and online tracking, and urethral dose sparing using inverse dose-painting when compatible with target coverage and disease anatomy.
Rectal balloon with air fillingDevice
A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility.
Urethral catheter loaded with beacon transpondersDevice
A urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Ultra-hypofractionated IGRT-VMAT 45 Gy in 5 fractions of 9 Gy | Experimental | Participants will receive definitive dose-escalated image-guided volumetric modulated arc radiotherapy for localized prostate adenocarcinoma. Radiotherapy will be delivered to 45 Gy in 5 fractions of 9 Gy each over 5 consecutive days, using organ-motion mitigation, urethral localization, online target tracking, urethral sparing, rectal balloon stabilization, and protocol-specified treatment planning and quality assurance procedures. Receives: Radiation: Ultra-hypofractionated IGRT-VMAT with organ-motion mitigation and urethral sparing; Device: Rectal balloon with air filling; Device: Urethral catheter loaded with beacon transponders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute treatment-related Grade ≥3 gastrointestinal or genitourinary toxicity
Incidence of treatment-related Grade 3 or higher gastrointestinal or genitourinary adverse events, graded using NCI CTCAE version 4.0.
Measured: From first protocol fraction through 90 days after completion of radiotherapy
Late treatment-related Grade ≥2 gastrointestinal or genitourinary toxicity
Incidence of treatment-related late Grade 2 or higher gastrointestinal or genitourinary adverse events, graded using NCI CTCAE version 4.0. Late Grade 3 or higher toxicity will be summarized separately.
Measured: More than 90 days through 60 months after completion of radiotherapy
Secondary outcomes (7)
Change from baseline in urinary quality of life
Change in urinary symptoms and urinary quality-of-life domains using validated instruments including EPIC-26 and IPSS. Change from baseline in EPIC-26 and IPSS, . The EPIC-26 (Expanded Prostate Cancer Index Composite score) questionnaire ranges between 0 and 100, with higher values indicating better quality of life. The IPSS (International Prostatic Symptoms Score) questionnaire ranges between 0 and 35 with higher values indicating worse urinary symptoms.
Measured: Baseline; approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Change from baseline in bowel quality of life
Change in bowel/rectal patient-reported outcomes using EPIC bowel-domain assessments. The EPIC-26 (Expanded Prostate Cancer Index Composite score) questionnaire ranges between 0 and 100, with higher values indicating better quality of life.
Measured: Baseline; approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Change from baseline in sexual function
Change in sexual function and sexual quality of life using EPIC-26 sexual-domain and IIEF instruments. The EPIC-26 (Expanded Prostate Cancer Index Composite score) questionnaire ranges between 0 and 100, with higher values indicating better quality of life. The IIEF (International Index of Erectile Function) questionnaire ranges between 0 and 30 with higher scores indicating better sexual function.
Measured: Baseline; approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
PSA kinetics after radiotherapy
Longitudinal serum PSA values after treatment, including PSA decline patterns and association with clinical outcomes.
Measured: Approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Biochemical relapse-free survival
Time to biochemical relapse, assessed using the Phoenix definition.
Measured: Through 60 months or longer after completion of radiotherapy
Patterns of recurrence
Local, nodal, or distant recurrence patterns summarized from clinically indicated imaging at or after biochemical relapse.
Measured: Through 60 months or longer after completion
Correlation of clinical and dosimetric variables with toxicity and quality-of-life outcomes (EPIC-26)
Analysis of correlations between treatment-planning dose metrics, clinical factors, toxicity, and EPIC-26 patient-reported outcomes. EPIC-26 (Expanded Prostate Cancer Index Composite score) questionnaire ranges between 0 and 100, with higher values indicating better quality of life.
Measured: Through 60 months after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start1 May 2013
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacao Champalimaud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Greco, MD, Fundacao Champalimaud
- Investigators
- Carlo Greco, MD, Principal investigator, Fundacao Champalimaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761889
- Sponsor's protocol ID
- HYPO
- Status last verified
- May 2026
- First submitted
- 26 Apr 2016
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Greco C, Pares O, Pimentel N, Louro V, Nunes B, Kociolek J, Marques J, Fuks Z. Early PSA density kinetics predicts biochemical and local failure following extreme hypofractionated radiotherapy in intermediate-risk prostate cancer. Radiother Oncol. 2022 Apr;169:35-42. doi: 10.1016/j.radonc.2022.02.016. Epub 2022 Feb 18.
PubMed 35189157
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02761889
- Acronym / sponsor ID
- HYPO
- Conditions
- Adenocarcinoma of the Prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Fundacao ChampalimaudUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-arm phase II study of definitive ultra-hypofractionated image-guided radiotherapy for localized prostate adenocarcinoma. The study is designed to evaluate the acute and late safety profile, feasibility, patient-reported quality-of-life outcomes, PSA kinetics, biochemical relapse-free survival, and clinical outcomes of dose-escalated IGRT-VMAT using organ-motion mitigation and urethral sparing.
Patients will receive 45 Gy in 5 fractions of 9 Gy each. Treatment planning will use CT/MRI-based target and organ-at-risk delineation. The protocol incorporates a rectal balloon for prostate stabilization and anatomical reproducibility, a urethral catheter loaded with beacon transponders for urethral localization and online motion tracking, and inverse dose-painting to reduce urethral dose when compatible with target coverage and disease anatomy. Erectile-related structures, including the neurovascular bundles, urogenital diaphragm, and penile bulb, may be contoured and recorded for quality-of-life and dosimetric analyses.
The primary safety assessments are treatment-related Grade 3 or higher gastrointestinal or genitourinary toxicity occurring from the first protocol fraction through 90 days after treatment completion, and treatment-related late Grade 2 or higher gastrointestinal or genitourinary toxicity occurring more than 90 days through 5 years after completion of radiotherapy. Late Grade 3 or higher gastrointestinal or genitourinary toxicity will be summarized separately. Clinically meaningful deterioration from baseline in urinary, bowel, and sexual patient-reported outcomes will be evaluated as a key safety and quality-of-life assessment.
Secondary assessments include PSA kinetics, biochemical relapse-free survival using the Phoenix definition, quality-of-life changes measured by EPIC, IPSS, and IIEF instruments, erectile and sexual function preservation, associations between clinical or dosimetric factors and outcomes, hormonal therapy exposure, and patterns of recurrence on clinically indicated imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Ultra-hypofractionated IGRT-VMAT 45 Gy in 5 fractions of 9 Gy | Experimental | Radiation: Ultra-hypofractionated IGRT-VMAT with organ-motion mitigation and urethral sparing, Device: Rectal balloon with air filling, Device: Urethral catheter loaded with beacon transpondersParticipants will receive definitive dose-escalated image-guided volumetric modulated arc radiotherapy for localized prostate adenocarcinoma. Radiotherapy will be delivered to 45 Gy in 5 fractions of 9 Gy each over 5 consecutive days, using organ-motion mitigation, urethral localization, online target tracking, urethral sparing, rectal balloon stabilization, and protocol-specified treatment planning and quality assurance procedures. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-hypofractionated IGRT-VMAT with organ-motion mitigation and urethral sparingImage-guided volumetric modulated arc radiotherapy delivered to 45 Gy in 5 fractions of 9 Gy each. Treatment uses CT/MRI-based planning, a rectal balloon for target immobilization and anatomical reproducibility, a urethral catheter loaded with beacon transponders for localization and online tracking, and urethral dose sparing using inverse dose-painting when compatible with target coverage and disease anatomy. | Radiation | Experimental: Ultra-hypofractionated IGRT-VMAT 45 Gy in 5 fractions of 9 Gy |
| Rectal balloon with air fillingA rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility. | Device | Experimental: Ultra-hypofractionated IGRT-VMAT 45 Gy in 5 fractions of 9 Gy |
| Urethral catheter loaded with beacon transpondersA urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking. | Device | Experimental: Ultra-hypofractionated IGRT-VMAT 45 Gy in 5 fractions of 9 Gy |
Primary outcome
Acute treatment-related Grade ≥3 gastrointestinal or genitourinary toxicity
Time frame: From first protocol fraction through 90 days after completion of radiotherapy
Incidence of treatment-related Grade 3 or higher gastrointestinal or genitourinary adverse events, graded using NCI CTCAE version 4.0.
Late treatment-related Grade ≥2 gastrointestinal or genitourinary toxicity
Time frame: More than 90 days through 60 months after completion of radiotherapy
Incidence of treatment-related late Grade 2 or higher gastrointestinal or genitourinary adverse events, graded using NCI CTCAE version 4.0. Late Grade 3 or higher toxicity will be summarized separately.
7 secondary outcomes
Change from baseline in urinary quality of life
Time frame: Baseline; approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Change from baseline in bowel quality of life
Time frame: Baseline; approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Change from baseline in sexual function
Time frame: Baseline; approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
PSA kinetics after radiotherapy
Time frame: Approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Biochemical relapse-free survival
Time frame: Through 60 months or longer after completion of radiotherapy
Patterns of recurrence
Time frame: Through 60 months or longer after completion
Correlation of clinical and dosimetric variables with toxicity and quality-of-life outcomes (EPIC-26)
Time frame: Through 60 months after completion of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 35189157Greco C, Pares O, Pimentel N, Louro V, Nunes B, Kociolek J, Marques J, Fuks Z. Early PSA density kinetics predicts biochemical and local failure following extreme hypofractionated radiotherapy in intermediate-risk prostate cancer. Radiother Oncol. 2022 Apr;169:35-42. doi: 10.1016/j.radonc.2022.02.016. Epub 2022 Feb 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Greco, MD principal investigator
Fundacao Champalimaud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-hypofractionated IGRT-VMAT with organ-motion mitigation and urethral sparing, Rectal balloon with air filling and Urethral catheter loaded with beacon transponders in people with Adenocarcinoma of the Prostate, run by Fundacao Champalimaud at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute treatment-related Grade ≥3 gastrointestinal or genitourinary toxicity (time frame: From first protocol fraction through 90 days after completion of radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02761889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.