Malignant Neoplasm of ProstateNCT01764646
Hypofractionated Radiation Therapy in Prostate Cancer
A study testing Intensity modulated radiation therapy, Volumetric modulated arc therapy and Image guided radiation therapy in people with Malignant Neoplasm of Prostate and Local Disease, run by Thomas Zilli at 9 sites in 8 countries.
Trial summary
RATIONALE: It is not yet known whether extreme hypofractionation is equally safe and effective than standard radiation therapy in treating prostate cancer. PURPOSE: This protocol presents a randomised phase II study aiming to investigate the tolerance and disease control of extreme hypofractionated Radiation Therapy… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Malignant Neoplasm of Prostate, Local Disease
- What is being tested?
- Intensity modulated radiation therapy, Volumetric modulated arc therapy and Image guided radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 9 sitesin 8 countries
- Study dates
- Sep 2012to Sep 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 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: >18
- WHO performance status ≤ 2
- Any patient where prophylactic lymph node irradiation is not required, i.e. risk of nodal microscopic involvement ≤ 20% (according to Roach et al (25):
- "N+ (in %) = (Gleason score - 6) x 10 + 2/3 PSA at diagnosis)"
- T-stage: cT1-cT3a.
- Previous TURP is allowed provided there is at least 8 weeks interval with radiotherapy.
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- Combined hormonal treatment (Neoadjuvant-concomitant androgen deprivation, AD, for 6 months) is mandatory if two or more of the following tumour characteristics are present: ≥cT2c, Gleason 4+3, PSA >10 ng/ml, perineural invasion, and/or >1/3 of positive biopsies. RT shall be delivered between 2 and 3 months (+/- 1 week) after starting AD and according to the following chronologic sequence:
- Neoadjuvant AD for 2 months (30 days of bicalutamide 50mg qd, and a 3-month slow-releasing LH-RH analog to be started 15 days after initiating bicalutamide).
- Randomization at the end of the neoadjuvant AD period (2 months after starting AD).
- Planning RT (to be started within 1 month after randomization (i.e., between the 2nd and 3th month after initiating AD)
- Concomitant and adjuvant HT for 4 more months (a second 3-month slow-releasing LH-RH analog injection).
Who cannot join
- Inability to obtain a written informed consent
- Patient preference to be treated with one rather than the other treatment arm.
- WHO performance status > 2
- cT3b,cT4
- Gleason score ≥8
- Clinical N+ on metastases work-up or N+ risk >20% (Roach algorithm)
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- Severe urinary obstructive symptoms (IPSS symptom index >19)
- Previous TURP less than 8 weeks before radiotherapy
- Previous prostate surgery other than TURP
Trial locations and contacts
9 sites in 8 countries.
9 sites in 8 countries
Spain2 sites
Teknon Oncologic Institute
Barcelona
Hospital Universitario Sanchinarro
Madrid
About this study
Official title: Stereotactic Body Radiation Therapy for cT1c - cT3a Prostate Cancer With a Low Risk of Nodal Metastases (≤ 20%, Roach Index): a Novalis Circle Phase II Prospective Randomized Trial
RATIONALE: It is not yet known whether extreme hypofractionation is equally safe and effective than standard radiation therapy in treating prostate cancer.
PURPOSE: This protocol presents a randomised phase II study aiming to investigate the tolerance and disease control of extreme hypofractionated Radiation Therapy for prostate cancer.
Read the detailed description
This protocol presents a randomised phase II study aiming to investigate the tolerance and disease control of extreme hypofractionated RT for prostate cancer by delivering 5 x 7.25 Gy = 36.25 Gy over two alternative time schedules: either over 9 days (study A), or over 28 days once-a-week, the same week-day (study B).
The total dose and fractionation schedules have been chosen based on the assumption of their isoeffectivity regarding potential late rectal effects to be expected with a maximum equivalent dose of 74 Gy in 2 Gy fractions and assuming an alpha/beta = 3 Gy for the rectum.
In both arms, the prescribed dose per fraction to the urethra and the surrounding transitional zone will be dropped from 7.25 Gy to 6.5 Gy with a simultaneous integrated boost (SIB) technique. A dose of 5 x 6.5 Gy is equivalent to 31 x 2 Gy assuming an alpha/beta = 3 Gy for the urethra and equivalent to 37 x 2 Gy assuming an alpha/beta = 1.5 Gy for microscopic tumour foci in the transitional zone surrounding the urethra. The two treatment regimens chosen will each be the object of a separate phase I-II study covered by the same protocol and performed in parallel by the participating centres. Randomised assignment to either of the two studies will be introduced to avoid selection bias in treatment assignment within each centre.
OBJECTIVES:
Primary
- To determine the risk of urinary, rectal and sexual acute and late toxicities rates in patients receiving two different time schedules of extreme hypofractionated radiation therapy
- Secondary
- To determine the Quality of life (EORTC QLQ-C30, Prostate cancer module EORTC QLQ-PR25) in patients receiving two different time schedules of extreme hypofractionated radiation therapy
- To determine the rate of local failure
- To determine in the two study arms the biochemical disease-free survival bDFS rate
- To determine in the two study arms the metastases-free survival rate
- To determine in the two study arms the disease-specific survival rate
OUTLINE:
This is a multicenter study.
Patients undergo extreme hypofractionated radiation therapy for prostate cancer by delivering 5 x 7.25 Gy = 36.25 Gy over two alternative time schedules:
Experimental Arm A: Over 9 days. Experimental Arm B: Over 28 days once-a-week, the same week-day. All patients will be followed up for at least 18 months to contribute to the analysis of the main endpoints of the study. With reference to the secondary endpoints, follow-up will be extended to 10 years.
Stopping rule: In order to avoid exposure of patients to a treatment that may be unsafe, acute GI and GU toxicity will be continuously monitored with the purpose of assisting in the decision of possibly interrupt recruitment in case of an alarming frequency.To this purpose, the procedure of Ivanova et al., 2005 will be applied.
- Conditions
- Malignant Neoplasm of Prostate, Local Disease
- Being tested
- Intensity modulated radiation therapy, Volumetric modulated arc therapy, Image guided radiation therapy
- Keywords
- Prostate cancer, Radiation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity modulated radiation therapyRadiation
Minimize radiation doses to surrounding area
Volumetric modulated arc therapyRadiation
Highly conformational dose distribution
Image guided radiation therapyRadiation
Follow target by the use of fiducial markers and ERB
| Study group | Role | What they receive |
|---|---|---|
| 9 days | Experimental | Patients undergo extreme hypofractionated radiation therapy (Intensity modulated radiation therapy, Volumetric modulated arc therapy, Image guided radiation therapy) once a week over 28 days Receives: Radiation: Intensity modulated radiation therapy; Radiation: Volumetric modulated arc therapy; Radiation: Image guided radiation therapy |
| 28 days | Experimental | Patients undergo extreme hypofractionated radiation therapy (Intensity modulated radiation therapy, Volumetric modulated arc therapy, Image guided radiation therapy) other 9 days. Receives: Radiation: Intensity modulated radiation therapy; Radiation: Volumetric modulated arc therapy; Radiation: Image guided radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance to treatment
Tolerance to treatment (urinary, rectal, sexual): Acute (up to 90 days) and late (up to 5 years) toxicity follow-up according to NCI CTCAE version 3.0
Measured: up to 5 years
Secondary outcomes (5)
1. Quality of life
Quality of life (EORTC QLQ-C30, Prostate cancer module EORTC QLQ-PR25)
Measured: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years
2. Local failure
Assessed by digital rectal examination (DRE). MRI or PET-CT with choline or acetate may be a confirmatory option. Biopsy confirmation is required for those patients with exclusive local failures and candidates for local salvage.
Measured: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years
3. Biochemical disease-free survival bDFS
Phoenix definition (PSA nadir + 2 ng/ml)
Measured: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years
4. Metastases-free survival
Outcomes 3 or 4 - investigations PET-CT choline
Measured: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years
5. Disease-specific survival
Alive/dead status, date and cause of death and prostate cancer disease status (outcomes 3/4 and 5).
Measured: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2020 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 5 x 7.25 Gy delivery in 2 alternative time Schedule: over 9 days every other treatment or over 28 days once a week
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Zilli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Zilli, University Hospital, Geneva
- Investigators
- Thomas Zilli, Dr, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764646
- Sponsor's protocol ID
- 11-196
- Status last verified
- May 2020
- First submitted
- 20 Dec 2012
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: No plan to share participant data for now
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation Therapy for cT1c - cT3a Prostate Cancer With a Low Risk of Nodal Metastases (≤ 20%, Roach Index): a Novalis Circle Phase II Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01764646
- Acronym / sponsor ID
- 11-196
- Conditions
- Malignant Neoplasm of Prostate, Local Disease
- Keywords
- Prostate cancer, Radiation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Thomas ZilliUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 9 Jan 2013 (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.
RATIONALE: It is not yet known whether extreme hypofractionation is equally safe and effective than standard radiation therapy in treating prostate cancer.
PURPOSE: This protocol presents a randomised phase II study aiming to investigate the tolerance and disease control of extreme hypofractionated Radiation Therapy for prostate cancer.
Detailed description
This protocol presents a randomised phase II study aiming to investigate the tolerance and disease control of extreme hypofractionated RT for prostate cancer by delivering 5 x 7.25 Gy = 36.25 Gy over two alternative time schedules: either over 9 days (study A), or over 28 days once-a-week, the same week-day (study B).
The total dose and fractionation schedules have been chosen based on the assumption of their isoeffectivity regarding potential late rectal effects to be expected with a maximum equivalent dose of 74 Gy in 2 Gy fractions and assuming an alpha/beta = 3 Gy for the rectum.
In both arms, the prescribed dose per fraction to the urethra and the surrounding transitional zone will be dropped from 7.25 Gy to 6.5 Gy with a simultaneous integrated boost (SIB) technique. A dose of 5 x 6.5 Gy is equivalent to 31 x 2 Gy assuming an alpha/beta = 3 Gy for the urethra and equivalent to 37 x 2 Gy assuming an alpha/beta = 1.5 Gy for microscopic tumour foci in the transitional zone surrounding the urethra. The two treatment regimens chosen will each be the object of a separate phase I-II study covered by the same protocol and performed in parallel by the participating centres. Randomised assignment to either of the two studies will be introduced to avoid selection bias in treatment assignment within each centre.
OBJECTIVES:
Primary
- To determine the risk of urinary, rectal and sexual acute and late toxicities rates in patients receiving two different time schedules of extreme hypofractionated radiation therapy
- Secondary
- To determine the Quality of life (EORTC QLQ-C30, Prostate cancer module EORTC QLQ-PR25) in patients receiving two different time schedules of extreme hypofractionated radiation therapy
- To determine the rate of local failure
- To determine in the two study arms the biochemical disease-free survival bDFS rate
- To determine in the two study arms the metastases-free survival rate
- To determine in the two study arms the disease-specific survival rate
OUTLINE:
This is a multicenter study.
Patients undergo extreme hypofractionated radiation therapy for prostate cancer by delivering 5 x 7.25 Gy = 36.25 Gy over two alternative time schedules:
Experimental Arm A: Over 9 days. Experimental Arm B: Over 28 days once-a-week, the same week-day. All patients will be followed up for at least 18 months to contribute to the analysis of the main endpoints of the study. With reference to the secondary endpoints, follow-up will be extended to 10 years.
Stopping rule: In order to avoid exposure of patients to a treatment that may be unsafe, acute GI and GU toxicity will be continuously monitored with the purpose of assisting in the decision of possibly interrupt recruitment in case of an alarming frequency.To this purpose, the procedure of Ivanova et al., 2005 will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 5 x 7.25 Gy delivery in 2 alternative time Schedule: over 9 days every other treatment or over 28 days once a week
| Arm | Type | Receives |
|---|---|---|
| 9 days | Experimental | Radiation: Intensity modulated radiation therapy, Radiation: Volumetric modulated arc therapy, Radiation: Image guided radiation therapyPatients undergo extreme hypofractionated radiation therapy (Intensity modulated radiation therapy, Volumetric modulated arc therapy, Image guided radiation therapy) once a week over 28 days |
| 28 days | Experimental | Radiation: Intensity modulated radiation therapy, Radiation: Volumetric modulated arc therapy, Radiation: Image guided radiation therapyPatients undergo extreme hypofractionated radiation therapy (Intensity modulated radiation therapy, Volumetric modulated arc therapy, Image guided radiation therapy) other 9 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: >18
- WHO performance status ≤ 2
- Any patient where prophylactic lymph node irradiation is not required, i.e. risk of nodal microscopic involvement ≤ 20% (according to Roach et al (25):
- "N+ (in %) = (Gleason score - 6) x 10 + 2/3 PSA at diagnosis)"
- T-stage: cT1-cT3a.
Key exclusion criteria (9 listed)
- Inability to obtain a written informed consent
- Patient preference to be treated with one rather than the other treatment arm.
- WHO performance status > 2
- cT3b,cT4
- Gleason score ≥8
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 |
|---|---|---|
| Intensity modulated radiation therapyMinimize radiation doses to surrounding area | Radiation | 28 days, 9 days |
| Volumetric modulated arc therapyHighly conformational dose distribution | Radiation | 28 days, 9 days |
| Image guided radiation therapyFollow target by the use of fiducial markers and ERB | Radiation | 28 days, 9 days |
Primary outcome
Tolerance to treatment
Time frame: up to 5 years
Tolerance to treatment (urinary, rectal, sexual): Acute (up to 90 days) and late (up to 5 years) toxicity follow-up according to NCI CTCAE version 3.0
5 secondary outcomes
1. Quality of life
Time frame: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years
2. Local failure
Time frame: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years
3. Biochemical disease-free survival bDFS
Time frame: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years
4. Metastases-free survival
Time frame: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years
5. Disease-specific survival
Time frame: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: Undecided. No plan to share participant data for now
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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.
Thomas Zilli, Dr principal investigator
University Hospital, Geneva
9 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensity modulated radiation therapy, Volumetric modulated arc therapy and Image guided radiation therapy in people with Malignant Neoplasm of Prostate and Local Disease, run by Thomas Zilli at 9 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, Belgium, Finland, Israel, Netherlands and 3 more countries. 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?
Results are not available in the source record.
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?
Tolerance to treatment (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2020; AzTrials last refreshed its copy on 1 Nov 2026.