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

Prostate Cancer Clinical Trial

— SINFRA_PROST  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02342054
• Other study ID #: SINFRA_PROST
• Status: Recruiting
• Phase: Phase 2
• First received: January 12, 2015
• Last updated: January 16, 2015
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2015
• Source: Hospital de Cruces
• Contact: Alfonso Gomez-Iturriaga, MD, PhD
• Phone: 946006233
• Email: ALFONSO.GOMEZDEITURRIAGAPINA[@]osakidetza.net
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: December 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• MRI-TRUS fusion guided Single Frac HDR

Locations

Country	Name	City	State
Spain	Hospital Universitario Cruces	Barakaldo	Bizkaia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Cruces

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize	Data to be collected are: i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize	12 months	Yes
Primary	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	12 months	No
Secondary	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	24 months	Yes
Secondary	Efficacy, measured by PSA	Patients will be followed with PSA at every follow-up;	24 months	No
Secondary	Patient satisfaction measured with Likert scale question	Patient Satisfaction will be measured with Likert scale question	24 months	No