Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients treated with a Single Fraction Real-Time High-Dose-Rate (HDR 19Gy)

MRI-TRUS fusion guided Single Frac HDR

Alfonso Gomez-Iturriaga, MD, PhD

Alfonso Gomez-Iturriaga, MD PhD

Francisco Casquero Ocio, MD PhD

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.

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

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

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

Data to be collected are:

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

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

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

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

Patient Satisfaction will be measured with Likert scale question

Hospital de Cruces

Staff physician department of Radiation Oncology

Patients treated with dose escalation to Dominant Intraprostatic Lesions

MRI-TRUS fusion guided real time HDR

Alfonso Gomez-Iturriaga, MD

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

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

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single Fraction Real-time High-Dose-Rate Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer	NCT02342054	Prostate Cancer	MRI-TRUS fusion...	18 Years -	Hospital de Cruces
Single Fraction Real-time High-Dose-Rate Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer	NCT02342054	Prostate Cancer	MRI-TRUS fusion...	18 Years -	Hospital de Cruces
Dose Escalation to Dominant Intraprostatic Lesions (DIL) With MRI-TRUS Fusion High Dose Rate (HDR) Prostate Brachytherapy	NCT01909388	Prostate Cancer	MRI-TRUS fusion...	18 Years -	Hospital de Cruces

Spots Global Cancer Trial Database for detection of dils by mri