Prostate CancerPhase 2BRAPROSTNCT01909388
Dose Escalation to Dominant Intraprostatic Lesions (DIL) With MRI-TRUS Fusion High Dose Rate (HDR) Prostate Brachytherapy
A Phase 2 study testing MRI-TRUS fusion guided real time HDR in people with Prostate Cancer, run by Alfonso Gomez-Iturriaga at 1 site in Spain.
Trial summary
The Magnetic Resonance (MR) provides high resolution of soft tissue images allowing an appropriate assessment of the local extent of the disease. Recent studies have shown an increase in sensitivity and specificity for the detection of Dominant intraprostatic lesions when using multiparametric MRI as a diagnostic tool… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI-TRUS fusion guided real time HDR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2013to Jul 2016
- Phase
- Phase 2
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men ≥18 years
- Histologically proven adenocarcinoma of the prostate
- Intermediate or high risk prostate cancer
- Intermediate risk prostate cancer patients must have:
- Clinical stage ≤ T2c, Gleason score = 7 and iPSA ≤ 20, or Gleason score ≤ 6 and iPSA > 10 and ≤ 20. High risk patients may have Clinical stage T3 Gleason score 8-10 PSA > 20 ng/ml
- A palpable nodule or a cluster of positive biopsies from a single region suggesting the presence of dominant nodule and with radiologic correlation by MRI.
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- Estimated life expectancy of at least 10 years.
- ECOG performance status of 0 - 2.
- Signature of informed conseny
Who cannot join
- Contraindications to interstitial prostate brachytherapy.
- If on coumadin therapy and NOT able to stop safely for 7 days.
- Does not have a localized high volume of intraprostatic disease and MRI contraindicated
- Unfit for general anesthetic
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Cruces
Barakaldo, Bizkaia, 48903
Alfonso Gomez-Iturriaga, MD PhD, +34946006000 ext. 6232, alfonso.gomezdeiturriaga@osakidetza.net
Alfonso Gomez-Iturriaga, MD, PhD
About this study
Official title: Phase II Study of Dose Escalation to Dominant Intraprostatic Lesions (DIL) With MRI-TRUS Fusion Real Time High Dose Rate (HDR) Brachytherapy in Patients With Intermediate and High Risk Prostate Cancer
The Magnetic Resonance (MR) provides high resolution of soft tissue images allowing an appropriate assessment of the local extent of the disease. Recent studies have shown an increase in sensitivity and specificity for the detection of Dominant intraprostatic lesions when using multiparametric MRI as a diagnostic tool in the staging of the disease.
Among the various irradiation techniques currently available for prostate cancer, Brachytherapy is the superior in terms of dose conformation; this conformation allows greater dose escalation, adjusting the isodoses to the prostate with exquisite accuracy, keeping healthy adjacent organs, such as the urethra and rectum, in a tolerable dose range
Read more
Brachytherapy companies have recently developed software allowing for TRUS-MR image fusion.
The purpose of this study is to demonstrate the feasibility of the delivery of a higher than prescription dose to the dominant intra-prostatic nodule as defined on multiparametric MRI.
Dose to prostate, and adjacent structure will remain the same as the current treatment practice. Timing and the delivery of brachytherapy will not change from our current practice
Read the detailed description
Treatment:
The patient's treatment will consist of combined Hypofractionated external beam (3750 cGray in 15 fractions) and MRI-TRUS fusion HDR brachytherapy boost (1 fraction of 1500 cGray.
Brachytherapy performed under general anesthesia as an outpatient procedure
TRUS-MRI fusion:
T2 axial volumetric sequence (VISTA) is imported directly from the picture archiving and communication systems (PACS). Then MR images are reconstructed and segmented. Target volumes (prostate gland, dominant intraprostatic lesions (DILs)and Organs at risk (OARs) urethra and rectum are delineated.
A transrectal sagittal volumetric ultrasound image is immediately adquired every 2 degrees, a rapid reconstruction algorithm converts the series of 2D images into a 3D volume, which is then displayed in axial, sagittal and coronal views and transferred to the module of fusion with the MRI.
The MRI images and the real-time sonography examination are displayed on a split-screen with the possibility of overlaying the images live in one image. A graphical user interface is used for rigid manual registration of the ultrasound and MRI volumes. This interface allows for displacements in the three dimensions and rotations, until both images are correctly superimposed.
Then the contoured structures are transferred to the US dataset, and these contours are slightly modified until a perfect matching with the US images is achieved.
Dose prescription:
The homogeneity parameters used for optimization aim for prostate V100 > 98%, V150 of 25-33%, V200 < 8%, where Vn is the fractional volume of the organ that receives n% of the prescribed dose, urethral dmax < 115% and rectal 1cc < 70% of prescribed dose.
The treatment plan will be manipulated such that the normally occurring high dose regions (125%, 150%) are positioned at the site of the identified disease
Endpoints Feasibility of higher doses administration, toxicity and efficacy will be measured
- Conditions
- Prostate Cancer
- Being tested
- MRI-TRUS fusion guided real time HDR
- Keywords
- Cancer, Prostate Cancer, Brachytherapy, Dose escalation, High Dose Rate, MRI-TRUS fusion, Detection of DILs by MRI
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-TRUS fusion guided real time HDRRadiation
Also called Dose escalation to 125% of prescription dose, Planning software Oncentra Prostate for Nucletron
| Study group | Role | What they receive |
|---|---|---|
| MRI-TRUS fusion guided real time HDR | Experimental | Patients treated with dose escalation to Dominant Intraprostatic Lesions Receives: Radiation: MRI-TRUS fusion guided real time HDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of delivery higher than prescription doses (at least 125% of the dose)using inverse planned MRI-TRUS fusion high dose rate (HDR) brachytherapy.
Use the multiparametric MRI to identify dominant intraprostatic lesions (DIL) and deliver higher doses to these lesions with real time HDR brachytherapy. The procedure will be considered feasible if DIL is covered by the 125% of prescription dose while respecting tolerance doses of adjacent normal organs
Measured: 12 months
Secondary outcomes (2)
Acute toxicity and tolerability compared to the historic cohort of patients treated with standard HDR brachytherapy
Data to be collected: urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity
Measured: 24 months
Efficacy assessed by PSA, Multiparametric MRI and prostate biopsy
Patients will be followed with PSA at every follow-up; Multiparametric MRI: at 12 months and 30 months; and TRUS guided biopsy: at 30 months
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfonso Gomez-Iturriaga
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Cruces
- Responsible party
- Sponsor-investigator, Alfonso Gomez-Iturriaga, Hospital de Cruces
- Investigators
- Alfonso Gomez-Iturriaga, MD, Principal investigator, Hospital de Cruces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909388
- Sponsor's protocol ID
- BRAPROST
- Acronym
- BRAPROST
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Dose Escalation to Dominant Intraprostatic Lesions (DIL) With MRI-TRUS Fusion Real Time High Dose Rate (HDR) Brachytherapy in Patients With Intermediate and High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT01909388
- Acronym / sponsor ID
- BRAPROST / BRAPROST
- Conditions
- Prostate Cancer
- Keywords
- Cancer, Prostate Cancer, Brachytherapy, Dose escalation, High Dose Rate, MRI-TRUS fusion, Detection of DILs by MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Alfonso Gomez-IturriagaUniversity, hospital or other
- Collaborators
- Hospital de Cruces
- Study start
- Jun 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 26 Jul 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.
The Magnetic Resonance (MR) provides high resolution of soft tissue images allowing an appropriate assessment of the local extent of the disease. Recent studies have shown an increase in sensitivity and specificity for the detection of Dominant intraprostatic lesions when using multiparametric MRI as a diagnostic tool in the staging of the disease.
Among the various irradiation techniques currently available for prostate cancer, Brachytherapy is the superior in terms of dose conformation; this conformation allows greater dose escalation, adjusting the isodoses to the prostate with exquisite accuracy, keeping healthy adjacent organs, such as the urethra and rectum, in a tolerable dose range
Brachytherapy companies have recently developed software allowing for TRUS-MR image fusion.
The purpose of this study is to demonstrate the feasibility of the delivery of a higher than prescription dose to the dominant intra-prostatic nodule as defined on multiparametric MRI.
Dose to prostate, and adjacent structure will remain the same as the current treatment practice. Timing and the delivery of brachytherapy will not change from our current practice
Detailed description
Treatment:
The patient's treatment will consist of combined Hypofractionated external beam (3750 cGray in 15 fractions) and MRI-TRUS fusion HDR brachytherapy boost (1 fraction of 1500 cGray.
Brachytherapy performed under general anesthesia as an outpatient procedure
TRUS-MRI fusion:
T2 axial volumetric sequence (VISTA) is imported directly from the picture archiving and communication systems (PACS). Then MR images are reconstructed and segmented. Target volumes (prostate gland, dominant intraprostatic lesions (DILs)and Organs at risk (OARs) urethra and rectum are delineated.
A transrectal sagittal volumetric ultrasound image is immediately adquired every 2 degrees, a rapid reconstruction algorithm converts the series of 2D images into a 3D volume, which is then displayed in axial, sagittal and coronal views and transferred to the module of fusion with the MRI.
The MRI images and the real-time sonography examination are displayed on a split-screen with the possibility of overlaying the images live in one image. A graphical user interface is used for rigid manual registration of the ultrasound and MRI volumes. This interface allows for displacements in the three dimensions and rotations, until both images are correctly superimposed.
Then the contoured structures are transferred to the US dataset, and these contours are slightly modified until a perfect matching with the US images is achieved.
Dose prescription:
The homogeneity parameters used for optimization aim for prostate V100 > 98%, V150 of 25-33%, V200 < 8%, where Vn is the fractional volume of the organ that receives n% of the prescribed dose, urethral dmax < 115% and rectal 1cc < 70% of prescribed dose.
The treatment plan will be manipulated such that the normally occurring high dose regions (125%, 150%) are positioned at the site of the identified disease
Endpoints Feasibility of higher doses administration, toxicity and efficacy will be measured
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-TRUS fusion guided real time HDR | Experimental | Radiation: MRI-TRUS fusion guided real time HDRPatients treated with dose escalation to Dominant Intraprostatic Lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men ≥18 years
- Histologically proven adenocarcinoma of the prostate
- Intermediate or high risk prostate cancer
- Clinical stage ≤ T2c, Gleason score = 7 and iPSA ≤ 20, or Gleason score ≤ 6 and iPSA > 10 and ≤ 20. High risk patients may have Clinical stage T3 Gleason score 8-10 PSA > 20 ng/ml
- A palpable nodule or a cluster of positive biopsies from a single region suggesting the presence of dominant nodule and with radiologic correlation by MRI.
Key exclusion criteria (4 listed)
- Contraindications to interstitial prostate brachytherapy.
- If on coumadin therapy and NOT able to stop safely for 7 days.
- Does not have a localized high volume of intraprostatic disease and MRI contraindicated
- Unfit for general anesthetic
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 |
|---|---|---|
| MRI-TRUS fusion guided real time HDRAlso: Dose escalation to 125% of prescription dose, Planning software Oncentra Prostate for Nucletron | Radiation | MRI-TRUS fusion guided real time HDR |
Primary outcome
Feasibility of delivery higher than prescription doses (at least 125% of the dose)using inverse planned MRI-TRUS fusion high dose rate (HDR) brachytherapy.
Time frame: 12 months
Use the multiparametric MRI to identify dominant intraprostatic lesions (DIL) and deliver higher doses to these lesions with real time HDR brachytherapy. The procedure will be considered feasible if DIL is covered by the 125% of prescription dose while respecting tolerance doses of adjacent normal organs
2 secondary outcomes
Acute toxicity and tolerability compared to the historic cohort of patients treated with standard HDR brachytherapy
Time frame: 24 months
Efficacy assessed by PSA, Multiparametric MRI and prostate biopsy
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
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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.
Alfonso Gomez-Iturriaga, MD principal investigator
Hospital de Cruces
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRI-TRUS fusion guided real time HDR in people with Prostate Cancer, run by Alfonso Gomez-Iturriaga at 1 site in Spain.
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 9 inclusion and 4 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 26 Jul 2013. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Alfonso Gomez-Iturriaga, MD, PhD (946006233, ALFONSO.GOMEZDEITURRIAGAPINA@osakidetza.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of delivery higher than prescription doses (at least 125% of the dose)using inverse planned MRI-TRUS fusion high dose rate (HDR) brachytherapy. (time frame: 12 months). 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 26 Jul 2013.