Single Fraction Real-time High-Dose-Rate Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer (SINFRA_PROST)

January 16, 2015 updated by: Alfonso Gomez-Iturriaga, Hospital de Cruces

Prospective Phase II Trial of Single Fraction Real-time High-Dose-Rate (19-HDR) Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer

High-dose rate brachytherapy (HDR-BT) is an advanced technology theorized to be more advantageous than LDR-BT and External Beam Radiotherapy (EBRT), to the patient himself, and in terms of resource allocation. Studies of HDR-BT monotherapy have encouraging results in terms of biochemical control, patient survival and toxicity, but there are still certain limitations that preclude recommending HDR-BT monotherapy outside the setting of a clinical trial.

The primary endpoint of this study is to evaluate the safety, tolerance and impact on quality of life (QoL) of the BT-HDR 19Gy administered in single fraction in patients with low and intermediate risk prostate cancer. Secondary endpoint is to measure the efficacy, in terms of cancer control and satisfaction of the patients undergoing the experimental treatment.

Forty nine patients will be recruited for the experimental procedure Quality of Life, tolerance, gastrointestinal and genitourinary toxicity will be assessed using standardized procedures and scales. Patient satisfaction with the procedure will be appraised using five-category predetermined Likert scale questions.

Two different types of intermediate analyses will be performed: with 15 and 30 recruited patients.

The experimental treatment tested in this study is very innovative. Since prostate cancer is the most frequent cancer in men in Spain, this trial results are very likely to have a major impact on the standard therapy for prostate cancer in our National Health Service, allowing for a higher number of Hospitals within our country and other countries starting protocols of HDR BT 19Gy in single fraction.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Treatment:

The patient´s treatment will consist of MRI-TRUS fusion single HDR brachytherapy fraction (1 fraction of 1900 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) Organs at risk (OARs) urethra and rectum are delineated.

A transrectal sagittal volumetric ultrasound image is immediately acquired 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:

Ultrasound images with the catheters in place will be exported to Oncentra Prostate. The prostate, Foley catheter and anterior rectal wall will be contoured. Catheters will be reconstructed on the planning system. Anatomy based inverse planning will be used for dwell time optimization.

The homogeneity parameters used for optimization aim are:

-For prostate V100 > 95%, V150 <35%, V200 < 6%, where Vn is the fractional volume of the organ that receives n% of the prescribed dose.

The dose constraints for the organ at risk will be:

  • Urethral dmax < 110% and
  • Rectal 1cc < 60% of prescribed dose.

Endpoints

Feasibility of higher doses administration, toxicity and efficacy will be measured

Study Type

Interventional

Enrollment (Anticipated)

49

Phase

  • 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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men older than 18 years old
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate
  • Clinical stage T1c/T2a disease
  • Low and Intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA < 20 ng/ml.
  • Prostate volume < 60 cc as determined by ultrasound, CT or MRI
  • Life expectancy of more than 10 years
  • Willing to give informed consent to participate in this clinical trial
  • Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
  • Eastern Cooperative Oncology Group (ECOG) of 0 - 2.
  • Give competent informed consent to participate in this trial.

Exclusion Criteria:

  • Documented nodal or distant metastases
  • Previous pelvic radiotherapy
  • Previous trans-urethral resection of prostate, previous prostatectomy or HIFU
  • Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors is permitted
  • Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >19
  • Contra-indication to radical prostate radiotherapy
  • Significant medical co-morbidity rendering patient unsuitable for general anaesthetic

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MRI-TRUS fusion guided Single Frac HDR
Patients treated with a Single Fraction Real-Time High-Dose-Rate (HDR 19Gy)
Radiation: MRI-TRUS fusion guided Single Frac HDR
Other Names:
  • Single Fraction real time HDR (19Gy)
  • Planning software Oncentra Prostate for Nucletron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measured by i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize
Time Frame: 12 months

Data to be collected are:

i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize
12 months
Quality of Life measured by alidated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC
Time Frame: 12 months
Quality of life will be measured through validated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicity measured by urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity
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, measured by PSA
Time Frame: 24 months
Patients will be followed with PSA at every follow-up;
24 months
Patient satisfaction measured with Likert scale question
Time Frame: 24 months
Patient Satisfaction will be measured with Likert scale question
24 months

Collaborators and Investigators

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

Sponsor

Hospital de Cruces

Investigators

  • Principal Investigator: Alfonso Gomez-Iturriaga, MD, PhD, Hospital Universitario Cruces/Biocruces

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2014

Primary Completion (ANTICIPATED)

October 1, 2015

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (ESTIMATE)

January 19, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 16, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SINFRA_PROST

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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