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An array of 17 gauge steel needles, 20 cm in length, is inserted under Ultrasound (US) guidance into the prostate and advanced to the base of the prostate. A template is used to maintain spacing and parallelism and the needles are individually locked into the template once positioned. A continuously acquired set of US images is obtained for treatment planning purposes. Each needle is connected to a Varisource afterloader and treatment is delivered using a 10 Curie Iridium-192 source. The needles are then removed.

HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a "boost" combined with external beam radiotherapy

HDR prostate brachytherapy

Matthew Schmid, MSc

High Dose Rate (HDR) temporary prostate brachytherapy offers a precise form of dose escalation for prostate cancer. Needles are placed, the position is confirmed and treatment is delivered. Previously High Dose Rate prostate brachytherapy was performed under TransRectal UltraSound (TRUS) guidance but planned with Computed Tomography (CT) imaging which introduced a source of error through needle displacement while transporting and repositioning patient. Recently Varian has introduced a one-step procedure where both implant and planning are based on UltraSound imaging and performed without patient repositioning. This planning system is approved by Health Canada and is commercially available.

This study will use High Dose Rate brachytherapy to treat 20 men. Treatment will be planned with TransRectal UltraSound and validated using Computed Tomography imaging.

Twenty men with intermediate risk prostate cancer, suitable for the combination of external beam radiotherapy and High Dose Rate brachytherapy will be entered in this study. High Dose Rate brachytherapy will be performed using TransRectal UltraSound guidance and then planned using both cone-beam Computed Tomography and TransRectal UltraSound. Planning by Computed Tomography is to check the reliability and reproducibility of UltraSound imaging to correctly identify the needle positions. Correct needle localization is essential because this is the basis for determining source dwell positions, dose calculation and dose optimization.

CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse

High Dose Rate (HDR)Prostate Brachytherapy With Vitesse tm

Precise location of the tip of each needle in 3-dimensional space relative to the prostate determines the pattern of dose delivery. Inaccuracies in needle tip location may lead to differences detected between UltraSound(US)-based and Computed Tomography (CT)-based plans.The distance of the needle tip (as identified on either CT images or US images) protruding beyond the template was measured in mm. The template acted as a fixed reference point as it was locked into the stabilizer/stepper apparatus. The 2 protrusion readings for each needle tip were compared, the difference recorded in mm, and categorized as \< 1 mm, 1-2 mm, 2-3 mm and \> 3 mm.

British Columbia Cancer Agency

MD FRCPC

Patients had either intermediate risk or favorable high risk disease suitable for definitive radiotherapy.

Localized Prostate Cancer

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Canada

Region of Enrollment

Dr Juanita Crook

Accuracy of Needle Tip Identification on TransRectal UltraSound Compared to Computed Tomography

HDR prostate brachytherapy: HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a "boost" combined with external beam radiotherapy

HDR Prostate Brachytherapy

Overall Study

HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion

2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy

HDR interstitial brachytherapy

This study will investigate the feasibility of using technology of ultrasound guided HDR brachytherapy to focally increase dose to regions within the prostate that are heavily infiltrated with cancer. Such regions, referred to as dominant intraprostatic lesions (DIL) can be visualized using diffusion contrast enhanced MRI employing an endo-rectal coil. The magnetic resonance (MR) images can be fused with the planning transrectal ultrasound (TRUS) prior to the brachytherapy procedure to design a dose distribution that will encompass the malignant volume with higher than the prescription dose. By its nature, brachytherapy has subvolumes that receive (for example)125% of the prescription dose or 150% of the prescription dose. With TRUS-guided and TRUS-planned HDR these areas can be manipulated to coincide with the DIL. The limit of dose escalation has been reached at whole prostate external beam doses of 81-86 Gy and still failure rates for intermediate and high risk disease are unacceptable. There is much interest in focal dose escalation and TRUS-guided HDR brachytherapy is perfectly suited to achieving this.

Methods: If a dominant nodule is visualized on dynamic contrast enhanced (DCE) MRI, it will be contoured in 3D and the images fused to the planning TRUS study that is done in preparation for brachytherapy (of any type: seeds or HDR). The patient's treatment will consist of the standard combined external beam (4600 centiGray (cGy) in 23 fractions) and HDR brachytherapy boost (2 fractions of 1000 cGy given on days 5 and 15 of the external beam course). During each HDR treatment the plan will be manipulated such that the normally occurring high dose regions (125%, 150%) are positioned at the site of the identified disease. Normally approximately 60% of the prostate volume receives 125% of the dose and 30% receives 150%. By ensuring that the inherent dosimetry favors treatment of the known cancer, no region of the prostate would be "underdosed". HDR treatments are performed under general anesthesia as an out patient procedure.

Statistical Analysis: This is a feasibility study and the data reported will be descriptive including the frequency with which the DIL can be visualized in this population, the DIL volume compared to total prostate volume, and the isodose that can encompass the DIL without violating dose constraints to adjacent organs (urethra and bladder). Toxicity will be monitored and efficacy will be assessed by repeat DCE MRI at 12 months and biopsy at 30 months.

High Dose Rate Prostate Brachytherapy: Dose Escalation to Dominant Intra-prostatic Nodule

High Dose Rate Prostate (HDR) Brachytherapy Dose Escalation to Dominant Intra-prostatic Nodule for Patients With Intermediate and High Risk Prostate Cancer

Feasibility of dose escalation to a minimum dose of 125% of prescription to 90% of the dominant intra-porstatic lesion (DIL) volume as defined on multiparametric endo-rectal magnetic resonance imaging (mpMRI) without exceeding critical organ dose constraints (Urethral volume receiving 115%= 0, Dose to 1cc of rectal wall \< 7 Gy). 2 Fractions were performed and the mean dose to 90% of DIL volume was averaged.

Time to normalize International Prostate Symptom Score (months). Score range 0-35 with 35 being worst outcome. Normalization refers to a return to baseline urinary function prior to treatment.

Efficacy assessed by biochemical PSA response reported at median 5 year follow up.

HDR prostate brachytherapy with dose escalation to 1250 cGy to the MRI-defined dominant intraprostatic lesion

HDR interstitial brachytherapy: 2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy

HDR Interstitial Brachytherapy

Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis.

Baseline PSA ng/mL

Gleason 7

Gleason 8 or 9

Gleason score is assigned by pathologist on examination of prostate biopsy material and ranges from 2 to 10 with higher score representing more aggressive undifferentiated tumors

Gleason score

Stage T1c

Stage T2a

Stage T2b

Clinical Tumor Stage is assigned from combination of digital rectal exam and imaging. T1 representants tumor that is neither palpable nor visible on imaging. cT2a and cT2b represent palpable/visible disease that is either less than half of one lobe (cT2a) or more than half of one lobe(cT2b).

clinical stage

HDR prostate brachytherapy with dose escalation to 1250 centiGray (cGy) to the MRI-defined dominant intraprostatic lesion

HDR interstitial brachytherapy: 2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy

High Dose Rate (HDR) Interstitial Brachytherapy

Average Mean Dose to 90% of DIL Volume

Months to normalization of International Prostate Symptom Score following treatment.

Acute Toxicity

All 25 underwent dose escalation to dominant lesion in prostate to median 132% of prescription dose

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse	NCT01248741	Prostate Cancer Interstitial Ra... High Dose Rate ... Ultrasound-base...	HDR prostate br...	45 Years - 80 Years	British Columbia Cancer Agency
High Dose Rate Prostate Brachytherapy: Dose Escalation to Dominant Intra-prostatic Nodule	NCT01605097	Prostate Cancer	HDR interstitia...	40 Years - 80 Years	British Columbia Cancer Agency

Spots Global Cancer Trial Database for interstitial radiation