Advice

Technology overview

Technology overview

This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology in other indications and settings.

About the technology

CE marking

Oncentra Prostate received a CE mark in May 1998. This was reissued in June 2013 and is valid until July 2017. The CE mark is held by the manufacturer, Nucletron, which is part of Elekta AB.

The individual components of the Oncentra Prostate system for HDR brachytherapy are listed below, alongside their device class:

  • software (class IIb)

  • afterloaders (class IIb)

  • applicators (class IIa and IIb)

  • radioactive sources (class IIb).

Description

The Oncentra Prostate system enables a single‑step, real‑time HDR prostate brachytherapy workflow that aims to reduce both the number and complexity of steps involved in administering the radiotherapy treatment plan. The system provides the clinician with 3D ultrasound guidance to show precisely where in the prostate gland the applicators are inserted, and it gives a clear view of the surrounding organs at risk from the radiation dose. The Oncentra software also provides tools to evaluate the radiotherapy treatment plan and assists in determining the best radiation dose distribution. By combining the imaging and treatment planning software, it eliminates the need to transfer the data to another software planning platform (as is the case when using a non‑integrated ultrasound machine for visualising the placement of the applicators). The treatment plan can be generated before the radiation source is applied and can be changed by adapting the position of the applicators without moving the patient.

The first commercial version of the system (marketed under the name SWIFT) was made available in 2002. Since then, Nucletron has released several versions, the most recent of which (version 4) became available in 2011. The information provided in this briefing relates to version 4.0 of the system and above, referred to as v4.x. NHS clinical oncology departments using the previous version of the system (version 3.x) can upgrade their software without the need to purchase additional hardware (although in some cases a hardware upgrade may be needed).

The Oncentra Prostate system comprises software and hardware components. The software components are:

  • Oncentra Prostate treatment planning software

  • database software.

The hardware components are:

  • The OncoSelect stepper. This controls the ultrasound probe and reports its position to the treatment planning software, enabling a 3D image to be constructed. The OncoSelect stepper also holds the OncoSmart template. The Oncentra Prostate system is also compatible with third‑party steppers. Depending on the type of stepper, Nucletron provides adapters for probe fixation.

  • The microSelectron HDR, or the more recent Flexitron HDR remote afterloading platform. These are computer‑controlled mobile units that contain the radiation source. The Flexitron has up to 40 channels (10, 20 or 40) and is designed to support a standardised workflow with less flexibility to change the treatment variables (such as the offset and the reference length). The microSelectron has up to 30 channels (6, 18 or 30) with higher accuracy of source positioning, and is designed to allow more flexibility and non‑standard approaches to treatment.

  • OncoSmart single‑use applicators or metal reusable applicators. These are used to guide the insertion of the radioactive source inside the prostate.

  • The OncoSmart template, used to secure the position of the applicators for insertion into the prostate. The system is also compatible with third‑party templates.

  • A USB dongle, which is a protection hardware key that prevents unauthorised copying of the software.

  • A laptop computer (with docking station) and monitor.

  • The EndoCavity Rotational Mover (ECRM), a computer‑controlled, motor‑driven rotational device used to rotate the ultrasound probe. This is an optional component that is only needed for rotational probe/stepper systems.

Advanced modules are available in addition to the basic Oncentra Prostate software platform. These are developed by MedCom and Pi Medical for Nucletron and provide different levels of functionality, allowing the clinician to optimise the radiotherapy treatment plan. Table 1 lists the radiotherapy planning tools provided by advanced versions of the Oncentra Prostate software (Pi Medical).

Table 1: Advanced radiotherapy planning features and the Oncentra Prostate software version in which they were first introduced

Feature

Functionality

Software version

Anatomy‑based inverse optimization (VBO)

Radiotherapy planning optimization based on anatomical information

1 and above

DVH‑Shaper

A graphical user interface that enables users to interact with the optimization engine

2 and above

Hybrid Inverse Planning and

Optimization (HIPO)

Automatic placement of the catheters, defined by the user, in such a way that all selected objectives are realised in the most effective way

3 and above

Multiplan

A toolkit for comparing different brachytherapy treatment plans, by comparing the dose volume histograms or directly the 3D dose distributions

3 and above

Live Automatic Catheter Reconstruction on Ultrasound (LACRUS)

A segmentation algorithm used to track an applicator in real‑time whilst it is inserted by the clinician during brachytherapy treatment

4 and above

Advanced shaper

A multi‑objective inverse optimization, based on the Dose Volume Histogram representation.

Not clear

According to the manufacturer, Oncentra Prostate 4.x software has the following features that were not available in previous versions:

  • A radiotherapy treatment plan manager module that automates routine tasks during treatment planning.

  • The ability to contour in arbitrary planes.

Table 2 lists the software modules available for installation with version 4.x.

Table 2: Modules available for installation with Oncentra Prostate software 4.x and their functionality

Module name

Functionality

Basic module

Main user interface and basic functions

SmoothBase

Patient management and administration database

3D Ultrasound

3D capabilities and ultrasound control

Auto recognition of catheters

Automatic catheter recognition onultrasound images

Auto contouring

Automatic VOl contouring

Inverse planning

Multi‑objective anatomy‑ and DVH‑based optimization and decision tools

RT‑HDR William Beaumont

Anatomic placement of catheters using customizable parameters according to the William Beaumont Hospital method

CT/MR and advanced optimizations

Radiotherapy treatment planning using CT and MRI images

Colour US (Doppler)

Support of colour ultrasound imaging for acquisition and planning

Fusion for all modalities

Volume fusion and registration of two volumes

Intended use

The Oncentra Prostate is a real‑time ultrasound‑guided system intended for HDR brachytherapy in patients with intermediate‑ or high‑risk localised prostate cancer.

Setting and intended user

HDR brachytherapy with the Oncentra Prostate may be offered as an in‑patient treatment in NHS clinical oncology departments equipped to deliver brachytherapy. Patients with intermediate‑ or high‑risk prostate cancer in these centres can have brachytherapy with the Oncentra Prostate either as monotherapy or in combination with EBRT to provide a boost dose.

The system is intended for use by qualified medical personnel suitably trained in brachytherapy procedures. Installation, maintenance, and training support services for the Oncentra Prostate are available from Nucletron.

Current NHS options

Current NHS options include either active surveillance or radical treatment of intermediate‑ or high‑risk localised prostate cancer. Active surveillance is considered for men with intermediate‑risk localised prostate cancer who do not wish to have immediate radical prostatectomy or radiotherapy, as outlined in NICE's guideline on prostate cancer: diagnosis and treatment.

For men with intermediate‑risk prostate cancer who wish to have radical treatment, and men with high‑risk localised prostate cancer, NICE recommends a combination of radical radiotherapy and androgen deprivation therapy. NICE suggests that these men can be offered HDR brachytherapy with EBRT. Brachytherapy should not be offered as a monotherapy for men with high‑risk localised prostate cancer.

The guideline makes no distinction between HDR prostate brachytherapy given as a 1‑step (real‑time) or 2‑step procedure, and the decision will be based on the clinical oncology department's equipment and ability to adopt a single‑step technique.

NICE is aware of the following CE‑marked device that appears to fulfil a similar function to the Oncentra Prostate:

  • Vitesse 3.0 (Varian).

Costs and use of the technology

Information on the cost of using the technology has been provided by the manufacturer. All costs presented below exclude VAT and were converted from euros to pounds sterling using purchasing power parities and exchange rates (Organisation for Economic Co‑operation and Development, September 2014).

The NHS acquisition cost of the Oncentra Prostate depends on whether an older system is being upgraded or an entire new system is being purchased. Both scenarios assume that an ultrasound scanner is already available in the brachytherapy unit. If not, the capital costs associated with a new ultrasound scanner should be added.

The manufacturer states a total cost of £34,250 (excluding VAT) for systems to be upgraded from Oncentra Prostate 3.x to 4.x. The upgrade is mainly related to changes in system software, with some minor hardware upgrades such as increased computer memory. This total includes the following costs:

  • Product upgrade (Oncentra Prostate 3.x to Oncentra prostate 4.x): £13,885.

  • Laptop cart package to enable hardware upgrade: £20,365.

The total cost of a new Oncentra Prostate 4.x system is £127,657 (excluding VAT and the optional components), including the following individual costs (all prices exclude VAT):

  • Oncentra Prostate 4.x: £97,295.

  • OncoSelect stepper and stepper encoder: £25,919.

  • Adapter set for the OncoSelect stepper: £4443 (other steppers can be used with the system, and the manufacturer provides adapters for probe fixation using different types of stepper).

Costs for optional extra components for either an upgrade or a new system:

  • An optional advanced imaging and advanced optimisation system: £19,439.

  • EndoCavity rotation mover (ECRM): £3703.

Costs for consumable items used with the Oncentra Prostate system:

  • Disposable applicators: during each brachytherapy session, around 16 disposable applicators are used per patient at a total cost of £2222.

  • Non‑disposable applicators: these can be sterilised and used for more than 1 patient, but are eventually disposed of after approximately 6 months. The cost for 16 non‑disposable applicators is £1290.

In addition to hardware and software costs, maintenance costs add up to £18,513 per year (excluding the first year).

Additional hardware costs associated with the Oncentra Prostate system (not included in costs listed above) include the following:

  • A HDR source and delivery unit (the afterloader) are required but are not core components of the Oncentra Prostate system. The Oncentra Prostate 4.x is only compatible with Nucletron afterloaders:

    • microSelectron Digital 30 Channels, costing £166,904

    • microSelectron Digital 18 Channels, costing £141,868

    • microSelectron Digital 6 Channels, costing £125,177

    • Flexitron HDR 40 Channels (220–240V), costing £183,593

    • Flexitron HDR 40 Channels (110–120V), costing £183,593

    • Flexitron HDR 20 Channels (220–240V), costing £156,054

    • Flexitron HDR 20 Channels (110–120V), costing £156,054

    • Flexitron HDR 10 Channels (230V), costing £137,695.

  • A compatible ultrasound scanner is needed in order to use the Oncentra Prostate 4.x, and this must be purchased separately. The system can be used with commercially available ultrasound systems using a regular video output and bi‑plane probe.

Staff must be appropriately trained in order to use the Oncentra Prostate system. Nucletron provides dedicated education and training in the form of peer‑to‑peer sessions. For example, a combined on‑site team training and consulting program is available at an additional cost of £13,073.

The anticipated lifespan of the technology is 10 years. The following assumptions were used to estimate a cost per treatment:

  • The technology is used in 240 patients (that is, 1 patient per day for 240 working days per year).

  • The duration of a brachytherapy session with the Oncentra Prostate 4.x is estimated to be 2–3 hours.

  • Personnel costs as follows: 1 urologist, 1 oncologist and 1 anaesthetist at £139 per hour (Curtis, 2013); 2 physicists at £100 per hour; 1 registered nurse at £100 per hour, 1 technician at £100 per hour and 1 operating department assistant at £21 per hour.

  • The use of a brachytherapy room at £200 per hour.

  • The re‑use of the metal applicators (where used) for a period of 6 months (that is, in 120 patients).

  • The annual capital costs were estimated using a standard 'annuity method' with an equipment lifespan of 10 years and a discount rate of 4% (Drummond et al. 2005).

The total cost per treatment if upgrading from the Oncentra Prostate 3.x to the 4.x is £2757 per treatment. The total cost per treatment if a new Oncentra Prostate 4.x is purchased is £2803 per treatment.

No other practical difficulties have been identified in using or adopting the technology. Nucletron provides refresher training for staff performing brachytherapy, ensuring compliance with the technology.

Current standard of care in the NHS is 2‑step HDR brachytherapy.

Likely place in therapy

The Oncentra Prostate is an option for managing intermediate‑ and high‑risk localised prostate cancer needing radical radiotherapy treatment. Different treatment modalities with various side effects are available for prostate cancer, and so men with prostate cancer should be given the opportunity to discuss their treatment options with specialist surgical and clinical oncologists. If the decision is made to have radical radiotherapy with HDR brachytherapy, then the Oncentra Prostate system can be used to deliver that treatment.

Specialist commentator comments

All specialist commentators agreed that single‑step HDR brachytherapy with the Oncentra Prostate system would save time compared with conventional 2‑step HDR brachytherapy treatment. However, they were not able to estimate how much time could be saved. They noted that an experienced brachytherapy team needed 2–3 hours to complete the single‑step real‑time procedure with the Oncentra Prostate, compared with approximately 6 hours to complete the 2‑step procedure (from administration of anaesthetic in theatre to the removal of the applicators).

Two commentators stated that although the total procedural time would be reduced, the overall length of hospital stay would not be significantly shortened using a single‑step real‑time approach with the Oncentra Prostate. This is because the patient would have to stay in hospital overnight regardless of the length of the procedure, because it is recommended that the patient stays in hospital until the urinary catheter is removed (the urinary catheter is only removed when the patient's urine becomes clear of blood, and the time taken to reach this stage would be no different for single‑step or 2‑step HDR brachytherapy). However, 1 specialist commentator felt that the total procedure time would be reduced by 3–4 hours and could potentially avoid the need for the patient to stay in hospital overnight.

Three commentators noted that because single‑step real‑time HDR brachytherapy is done in a single room, the risk of applicators being dislodged is lower than with the 2‑step procedure. They commented that treatment delivery is more accurate when there is no movement of the applicators and when the overall procedural time is reduced.

Two commentators noted that the single‑step real‑time process is more straightforward because there is no dependence on the availability of a CT or MRI scanner, and the patient does not need to be transferred to another room. Because no CT or MRI is needed, using the Oncentra Prostate system would reduce the number of staff involved in the procedure and therefore reduce the associated costs.

One commentator noted that the microSelectron HDR and the Flexitron HDR afterloaders can be used to treat other cancer sites, which may offset the additional costs in departments that share these resources for treating different cancer types. The same commentator also noted that the Oncentra Prostate 4.x can be used for low‑dose rate seed implant prostate brachytherapy. One specialist commentator stated that the Oncentra Prostate system is also compatible with third‑party steppers and templates.

All of the commentators confirmed that there are only minor changes between the Oncentra Prostate v4.x and v3.x. In terms of hardware, these changes are mainly the introduction of sagittal ultrasound acquisition support, which improves the image quality and therefore speed and accuracy. In terms of the software, the changes between the 2 versions are mostly improvements to existing features rather than major changes that would affect patient outcomes. In general, the changes make the system more user‑friendly, potentially more accurate and faster.

Equality considerations

NICE is committed to promoting equality and eliminating unlawful discrimination. We aim to comply fully with all legal obligations to:

  • promote race and disability equality and equality of opportunity between men and women, and

  • eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief, in the way we produce our guidance (these are protected characteristics under the Equality Act [2010]).

Men aged over 50 years and men of African‑Caribbean family origin are both at increased risk of prostate cancer. Age and race are protected characteristics defined in the Equality Act (2010).

Patient and carer perspective

Single‑step real‑time HDR brachytherapy is a safe and effective procedure. However, as with most cancer treatments, there are some risks associated with HDR brachytherapy with EBRT. It is therefore important that all men offered this treatment discuss the benefits and side effects with their doctor and clinical team. They can then make an informed decision about their treatment.

The long‑term risks associated with the procedure are:

  • impotence (problems with getting and keeping an erection)

  • narrowing of the urethra and thus difficulty in passing urine

  • proctitis (inflammation of the back passage).

More detailed information on these risks can be found in CRUK's guide on prostate brachytherapy (Cancer Research UK, 2014b).