Dose Escalation to Dominant Intraprostatic Lesions (DIL) With MRI-TRUS Fusion High Dose Rate (HDR) Prostate Brachytherapy (BRAPROST)

July 23, 2013 updated by: Alfonso Gomez-Iturriaga

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Recruiting
        • Hospital Universitario Cruces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.
  • Estimated life expectancy of at least 10 years.
  • ECOG performance status of 0 - 2.
  • Signature of informed conseny

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MRI-TRUS fusion guided real time HDR
Patients treated with dose escalation to Dominant Intraprostatic Lesions
Radiation: MRI-TRUS fusion guided real time HDR
Other Names:
  • Planning software Oncentra Prostate for Nucletron
  • Dose escalation to 125% of prescription dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute toxicity and tolerability compared to the historic cohort of patients treated with standard HDR brachytherapy
Time Frame: 24 months
Data to be collected: urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity
24 months
Efficacy assessed by PSA, Multiparametric MRI and prostate biopsy
Time Frame: 30 months
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
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alfonso Gomez-Iturriaga

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital de Cruces

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alfonso Gomez-Iturriaga, MD, Hospital Universitario Cruces

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BRAPROST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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