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Prostate CancerPhase 2SINFRA_PROSTNCT02342054

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

A Phase 2 study testing MRI-TRUS fusion guided Single Frac HDR in people with Prostate Cancer, run by Hospital de Cruces at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. 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 Single Frac HDR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteSpain
Study dates
Oct 2014to Dec 2017
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 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Alfonso Gomez-Iturriaga, MD, PhD contact

946006233

ALFONSO.GOMEZDEITURRIAGAPINA@osakidetza.net

Spain1 site, 1 recruiting

  • Hospital Universitario Cruces

    Barakaldo, Bizkaia, 48903

    Alfonso Gomez-Iturriaga, MD PhD, +34946006000 ext. 6232, alfonso.gomezdeiturriaga@osakidetza.net

    Alfonso Gomez-Iturriaga, MD, PhD

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read more

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.

Read the 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

Conditions
Prostate Cancer
Being tested
MRI-TRUS fusion guided Single Frac HDR
Keywords
Cancer, Prostate Cancer, Brachytherapy, Dose escalation, High Dose Rate, MRI-TRUS fusion, Detection of DILs by MRI, SINGLE FRACTION
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 Single Frac HDRRadiation

    Also called Single Fraction real time HDR (19Gy), Planning software Oncentra Prostate for Nucletron

Study groups in NCT02342054
Study groupRoleWhat they receive
MRI-TRUS fusion guided Single Frac HDRExperimentalPatients treated with a Single Fraction Real-Time High-Dose-Rate (HDR 19Gy)
Receives: Radiation: MRI-TRUS fusion guided Single Frac HDR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety measured by i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize

    Data to be collected are:

    1. urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize

    Measured: 12 months

  2. Quality of Life measured by alidated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC

    Quality of life will be measured through validated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC

    Measured: 12 months

Secondary outcomes (3)

  1. Acute toxicity measured by urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity

    Data to be collected: urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity

    Measured: 24 months

  2. Efficacy, measured by PSA

    Patients will be followed with PSA at every follow-up;

    Measured: 24 months

  3. Patient satisfaction measured with Likert scale question

    Patient Satisfaction will be measured with Likert scale question

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionOct 2015 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02342054
Sponsor's protocol ID
SINFRA_PROST
Acronym
SINFRA_PROST
Status last verified
Jan 2015
First submitted
12 Jan 2015
Last updated
19 Jan 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Gomez-Iturriaga A, Casquero F, Pijoan JI, Minguez P, Espinosa JM, Irasarri A, Bueso A, Cacicedo J, Buchser D, Bilbao P. Health-related-quality-of-life and toxicity after single fraction 19 Gy high-dose-rate prostate brachytherapy: Phase II trial. Radiother Oncol. 2018 Feb;126(2):278-282. doi: 10.1016/j.radonc.2017.10.039. Epub 2017 Nov 15.

    PubMed 29153462

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MRI-TRUS fusion guided Single Frac HDR in people with Prostate Cancer, run by Hospital de Cruces 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 10 inclusion and 7 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 Jan 2015. 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?

Safety measured by i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize (time frame: 12 months). 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 NCT02342054, 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 19 Jan 2015.

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