ProFocal Score — Focal Therapy Modality Selector

About Focal Therapy & Shared Decision Making

Modality overview · Treatment tradeoffs · Evidence base

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⚖ Shared Decision Making — Understanding Your Options

For localised prostate cancer, robotic-assisted radical prostatectomy (RARP) and radiotherapy (EBRT / brachytherapy) remain the gold standard treatments with the longest evidence base for oncologic control. Both offer well-established cure rates and are endorsed by all major guidelines (EAU, AUA, NCCN).

Focal therapy is an emerging, minimally invasive alternative that targets only the index lesion rather than the whole gland. It aims to achieve oncologic control whilst preserving urinary continence, erectile function, and quality of life to a greater degree than whole-gland treatments. However, it is not yet a guideline-endorsed standard of care and patients must understand the following tradeoffs before proceeding.

✓ Potential Advantages

· Preservation of erectile function and continence
· Shorter recovery time, often day-case procedure
· Retreatment possible if cancer recurs
· Radical therapy (surgery/radiation) remains available
· Reduced impact on quality of life

⚠ Tradeoffs & Limitations

· More intensive surveillance required post-treatment
· PSA monitoring, repeat MRI, and follow-up biopsies
· Risk of residual or recurrent cancer in untreated areas
· Potential need for further therapy in future
· Less long-term outcome data than surgery/radiation
· Requires specialist centre with MRI fusion capability

Focal Therapy Modalities

HIFU

High Intensity Focused Ultrasound

A transrectal probe focuses high-energy ultrasound waves to a precise focal point within the prostate, generating temperatures exceeding 80°C and causing coagulative necrosis. The Focal One® and Sonablate® devices allow real-time MRI-ultrasound fusion targeting. Treatment is performed under general or spinal anaesthesia as a day-case procedure.

Thermal Transrectal Day-case No ionising radiation Retreatable

Cryotherapy

Cryoablation / Partial Gland Ablation

Argon gas–cooled cryoneedles are placed transperineally under ultrasound guidance into the target zone. Repeated freeze-thaw cycles to −40°C destroy tissue through ice crystal formation and vascular disruption. The iceball is monitored in real time. Urethral warming is used to protect the urethra during treatment.

Cryo-ablation Transperineal Ultrasound-guided Argon gas Retreatable

TULSA-PRO

Transurethral Ultrasound Ablation

A directional ultrasound applicator is placed within the prostatic urethra and rotated to deliver precisely shaped thermal ablation outward from the centre of the gland. Treatment is performed entirely within the MRI bore, allowing real-time MR thermometry to guide and confirm ablation boundaries. The ECD (endorectal cooling device) protects the rectal wall.

Thermal Transurethral MRI-guided Real-time thermometry MR suite required

IRE

Irreversible Electroporation (NanoKnife®)

Multiple transperineal electrodes deliver high-voltage, ultra-short electrical pulses that permanently disrupt cell membrane integrity, causing non-thermal cell death. Because the mechanism is electrical rather than thermal, critical structures including the neurovascular bundles, urethra, and rectum are relatively preserved. Requires general anaesthesia with full neuromuscular blockade.

Non-thermal Transperineal NVB-sparing GA + paralysis Retreatable

📈 Evidence: Focal Therapy vs Surveillance — Freedom from Radical Therapy

Martin SC, Gonzalez S, Kwan L et al. · J Urol 2025;214(2):177–187 · Senior author: Leonard S. Marks MD, UCLA

              SVG reconstruction based on published figure — not a reproduction. For exact data refer to the original article (PMID 40257918).
            

Key Findings

~71%

of focal therapy patients remained RP/RT-free at 11 years

~39%

of surveillance-only patients remained RP/RT-free at 11 years

P <0.01

Log-rank test. Median survival of No FT group crossed 0.5 at ~3.5 years (dashed line)

Study Context

Single-centre UCLA cohort. FT group n=99; No FT group n=271. All patients had baseline MRI-guided biopsy showing low- to intermediate-risk prostate cancer. Focal therapy offered from 2016 for higher-risk or progressing cancers. Authors note specialist-centre limitation.

/ 50 pts

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HIFU

—

Cryo

—

TULSA-PRO

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IRE

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Anatomic Reference Map

Axial & Sagittal cross-sections · Prostate zonal anatomy

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Axial View — Mid-Gland

Sagittal View — Craniocaudal Anatomy

Peripheral Zone (PZ)

Transition Zone (TZ)

Central Zone (CZ)

Prostatic Urethra

Neurovascular Bundle (NVB)

External Urethral Sphincter (EUS) — d_EUS measured from inferior lesion margin to proximal sphincter border on sagittal MRI

Ant / Post Equator

Axial view is a schematic cross-section at mid-gland level. NVBs depicted at posterolateral 5 & 7 o'clock positions. Sagittal view shows left paramedian plane. Not to scale.

⊙

Imaging Characterisation

mpMRI visibility · PSMA-PET · Unfold AI contour analysis

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        Imaging characterisation is a clinical pre-requisite for focal therapy and does not contribute to the anatomical complexity score. Findings here inform eligibility, targeting confidence, and disease extent — and generate clinical flag alerts.
      

mpMRI — Lesion Visibility

          MRI-visible index lesion is a prerequisite for MRI-guided focal therapy. PI-RADS score and size should be confirmed on a prostate MRI meeting ACR PI-RADS v2.1 standards, ideally at 3T with endorectal coil or surface coil protocol.
        

Yes — MRI-visible lesion confirmed

PI-RADS ≥ 3 lesion identified on mpMRI · Target defined for fusion biopsy and treatment planning

✓

No — No MRI-visible lesion

Lesion not visible on mpMRI · MRI-guided focal therapy is not feasible without a defined target

Not yet performed / pending

mpMRI not yet available — required before focal therapy planning can proceed

—

PSMA-PET — Disease Extent

          PSMA-PET/CT (⁶⁸Ga-PSMA or ¹⁸F-DCFPyL) provides whole-body staging. For focal therapy candidates, PSMA-PET detects occult nodal or metastatic disease that would contraindicate focal-only treatment, and may identify additional intraprostatic foci not visible on MRI.
        

Not performed / Not indicated

PSMA-PET not yet done or not clinically indicated for this risk category

—

Negative — Intraprostatic lesion only (organ-confined)

PSMA avidity confined to prostate · No nodal or distant disease · Favourable for focal therapy

✓

Multiple intraprostatic foci — No extraprostatic disease

≥ 2 PSMA-avid foci within prostate · Multifocal disease — index lesion focal therapy may leave significant disease untreated

⚠

Extraprostatic / Nodal / Metastatic PSMA uptake

PSMA activity beyond prostate capsule · Focal therapy alone is inadequate — systemic and/or multimodal therapy required

Unfold AI — Prostate Contour & Targeting Analysis

          Unfold AI (Avenda Health) generates a 3D probabilistic cancer map of the prostate from mpMRI and biopsy data, estimating cancer burden distribution across the gland. The output guides treatment zone planning and identifies contralateral disease risk — directly informing the choice between hemi-gland, quadrant, and focal ablation.
        

Not performed

Unfold AI analysis not yet available · Treatment zone to be defined by conventional MRI + biopsy mapping

—

Performed — Unilateral / Focal disease confirmed

3D cancer map supports index lesion targeting · Contralateral lobe low probability · Favourable for focal or hemi-ablation

✓

Performed — Bilateral or Diffuse disease pattern

Cancer probability map shows bilateral involvement or high-risk contralateral foci · Focal ablation may leave significant disease untreated · Consider whole-gland treatment

⚠

Performed — Discordant with mpMRI (additional foci identified)

Unfold AI identifies disease burden not apparent on MRI alone · Treatment plan should be revised to incorporate AI-identified targets · Discuss with treating team before finalising ablation zone

⚡

◎

Treatment Margin Planning

Ablation margin · Modality-specific margin feasibility

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        Treatment margin is the additional tissue ablated beyond the visible tumour boundary to account for microscopic extension and targeting uncertainty. A wider margin improves oncologic control but increases collateral injury risk to the urethra, NVBs, EUS, and rectum. Margin selection must be reconciled against the proximity scores in the P+S and R domains above.
      

Intended Ablation Margin Beyond Index Lesion

          Select the planned isotropic margin around the visible MRI lesion. Margin should be chosen before considering proximity constraints — the P+S and R scores then indicate where full margin delivery is compromised.
        

Margin not yet defined

Treatment planning not initiated · Margin to be determined at MDT or pre-procedure planning session

—

Targeted / Zero margin — Lesion boundary only

Ablation confined to visible MRI lesion · Highest functional preservation · Highest risk of marginal miss · Typically reserved for lesions immediately adjacent to critical structures

0 mm

Narrow margin — 5 mm

Standard minimum margin for focal ablation · Balances oncologic safety with functional preservation · May be appropriate near NVB, urethra, or EUS

5 mm

Standard margin — 10 mm

Preferred oncologic margin for intermediate-risk disease · Greater confidence in microscopic extension coverage · Increased proximity risk near critical structures

10 mm

Wide margin — 15 mm or hemi-gland

Extended coverage for higher-risk lesions, multifocal disease, or unfavourable intermediate risk · Approaches hemi-gland ablation territory · Significant proximity implications for urethra and contralateral NVB

15 mm+

Tumor Zone & Side

Prostate zone · Laterality

0 pts

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Prostate Zone (affects heat/cold delivery)

Peripheral Zone

Transition Zone

Central Zone

Tumor Laterality

Unilateral

Bilateral

Tumor Orientation

Anterior vs posterior · Craniocaudal location

0 pts

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Anterior vs Posterior

Posterior

Anterior + Central

Vertical Location (Craniocaudal)

Base / Mid

Apex

Spanning Base–Apex

P+S

Proximity to Critical Structures

EUS · NVB · Rectal wall

0 pts

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Distance to External Urethral Sphincter (EUS) — Apex to Sphincter

          dEUS is measured on sagittal MRI from the inferior margin of the index lesion (or ablation zone far edge) to the proximal border of the striated urethral sphincter. See Anatomic Reference Map above for diagram. Sphincter injury risks permanent stress urinary incontinence — the most feared functional complication of apical focal therapy.
        

> 10 mm — Safe distance

Full margin delivery achievable at apex · Sphincter preservation expected · See green zone on diagram

5–10 mm — Borderline

Margin must be trimmed at apex · TULSA periurethral thermal effect critical · Intraoperative US monitoring mandatory · See amber zone on diagram

< 5 mm — High risk

Sphincter in ablation field · SUI risk high · Zero-margin or ablation modification essential · Consider alternative approach · See red zone on diagram

Neurovascular Bundle (NVB) Proximity

> 5 mm

≤ 5 mm

Abutting / Involving NVB

Rectal Wall Proximity

> 6 mm

4–6 mm

< 4 mm

Radius from Urethra

Minimum distance from prostatic urethra

0 pts

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Minimum Distance from Prostatic Urethra

> 10 mm

5–10 mm

< 5 mm or Periurethral

PSA

Preoperative PSA Assessment

Absolute PSA · PSA density · Kinetics · Risk stratification

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        PSA is the primary biochemical staging tool for prostate cancer and informs risk stratification, focal therapy eligibility, post-treatment surveillance thresholds, and the definition of biochemical recurrence (BCR). Preoperative PSA must be measured off 5-ARI and at least 4 weeks after prostate biopsy.
      

Absolute Preoperative PSA (ng/mL)

          Measured at minimum 4 weeks post-biopsy and off any 5α-reductase inhibitor. Use the most recent pre-treatment value. Note: PSA is prostate-specific, not cancer-specific — benign prostatic hyperplasia (BPH) and prostatitis elevate PSA independently of cancer.
        

< 4 ng/mL

Low absolute PSA · Within normal range · Low systemic tumour burden consistent with localised disease

4–10 ng/mL — Diagnostic grey zone

Standard detection range · PSA density and ancillary biomarkers (PHI, 4Kscore) should inform biopsy decision and cancer characterisation

4–10

10–20 ng/mL — Elevated

Elevated PSA requiring careful staging · Increased probability of unfavourable intermediate or high-risk disease · PSMA-PET staging strongly recommended before focal therapy

10–20

> 20 ng/mL — High / Very high risk

PSA > 20 defines high-risk disease per EAU/NCCN guidelines · Focal therapy generally not recommended without comprehensive staging · PSMA-PET/CT and MDT review mandatory

>20

PSA Density (PSAD) — PSA ÷ Prostate Volume (ng/mL/cc)

          PSA density normalises PSA for prostate volume (calculated from MRI volumetry: V = π/6 × AP × RL × CC). PSAD ≥ 0.15 ng/mL/cc is the widely accepted threshold for clinically significant cancer. Higher PSAD independent of absolute PSA correlates with aggressive biology and increases likelihood of missed contralateral or multifocal disease.
        

PSAD < 0.10 ng/mL/cc — Low

PSA excess accounted for by gland volume · Low density cancer burden · Favourable for focal approach · Below threshold for clinically significant cancer

<0.10

PSAD 0.10–0.15 ng/mL/cc — Borderline

Approaching clinically significant threshold · Confirm systematic biopsy template is complete · Correlate with Unfold AI cancer mapping if available

0.10–0.15

PSAD 0.15–0.30 ng/mL/cc — Elevated

Above clinically significant threshold · Increased index cancer burden and risk of satellite foci · Systematic biopsy recommended alongside targeted cores · Wider ablation margins warranted

0.15–0.30

PSAD > 0.30 ng/mL/cc — High

High PSA density strongly associated with multifocal and aggressive disease · Focal therapy may be insufficient · PSMA-PET and systematic biopsy essential · Consider whole-gland treatment discussion at MDT

>0.30

PSA Kinetics — Velocity (PSAV) & Doubling Time (PSADT)

          PSA velocity (ng/mL/yr) and doubling time reflect the rate of PSA rise over serial measurements. Rapid kinetics suggest aggressive tumour biology independent of absolute PSA level. Requires minimum 3 measurements over ≥ 18 months for reliable calculation. PSAV > 2 ng/mL/yr or PSADT < 3 years are associated with worse outcomes and altered screening algorithms.
        

Stable / Slow — PSAV < 0.75 ng/mL/yr or PSADT > 3 years

Slow-growing indolent disease kinetics · Favourable biology · Consistent with low-volume localised cancer

Slow

Moderate — PSAV 0.75–2.0 ng/mL/yr or PSADT 1–3 years

Intermediate kinetics · Acceptable but warrants repeat PSA confirmation and accurate staging · Discuss with patient that active surveillance would require close PSA monitoring

Moderate

Rapid — PSAV > 2.0 ng/mL/yr or PSADT < 1 year

Rapid PSA kinetics suggest aggressive biology · High risk of understaging with focal-only treatment · PSMA-PET and MDT discussion strongly recommended · PSA rise > 2 ng/mL/yr after focal therapy = widely used biochemical recurrence threshold (Phoenix + 2 nadir)

Rapid

Insufficient serial data — Kinetics not calculable

Fewer than 3 PSA measurements or < 18 months of data · Record baseline PSA now for future kinetics calculation post-treatment

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Ancillary PSA-based Biomarkers (if performed)

          Reflex biomarkers improve specificity for clinically significant cancer (csPC) in the PSA grey zone (4–10 ng/mL) and may inform focal therapy eligibility or the need for re-staging. %fPSA, PHI (Prostate Health Index), and 4Kscore are blood-based; SelectMDx and ExoDx are urine-based; Confirm MDx is a tissue-based epigenetic marker.
        

Not performed / Not applicable

No ancillary biomarker testing — proceed with PSA, PSAD, and MRI-based risk stratification

—

Low risk on ancillary biomarker — Below csPC threshold

%fPSA > 25% · PHI < 27 · 4Kscore < 7.5% · SelectMDx low risk · Reduces probability of clinically significant cancer · Supports conservative/focal management

Low risk

Intermediate risk on ancillary biomarker

PHI 27–55 · 4Kscore 7.5–15% · Intermediate probability of csPC · Systematic biopsy alongside targeted biopsy recommended before committing to focal approach

Intermediate

High risk on ancillary biomarker — Above csPC threshold

PHI > 55 · 4Kscore > 15% · %fPSA < 10% · High probability of clinically significant or high-grade cancer · Comprehensive systematic + targeted biopsy and PSMA-PET staging before focal therapy planning

High risk

Post-Treatment PSA Surveillance Plan

          Following focal therapy, PSA does not fall to undetectable (unlike radical prostatectomy). A PSA nadir is reached at 3–6 months, with the residual gland contributing background PSA. Biochemical recurrence (BCR) after focal therapy is defined as: PSA rise ≥ 2 ng/mL above nadir (adapted Phoenix criteria). Serial PSA at 3, 6, and 12 months post-treatment, then 6-monthly, is the standard surveillance schedule.
        

Surveillance plan confirmed — PSA schedule agreed with patient

Post-treatment monitoring schedule in place · 3/6/12 months then 6-monthly · Patient understands PSA will not be undetectable

✓

Surveillance plan not yet discussed

Post-treatment PSA monitoring to be agreed at pre-procedure consent appointment · Patient education on BCR definition and surveillance intensity required

Pending

Gleason Grade Group

Index lesion grade · Positive cores · % Pattern 4

0 pts

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Grade Group (Index / Dominant Lesion)

Grade Group 1 Gleason 3+3=6

Low risk · Ideal focal candidate

Grade Group 2 Gleason 3+4=7

Favourable intermediate risk · Established focal indication

Grade Group 3 Gleason 4+3=7

Unfavourable intermediate risk · Focal with caution

Grade Group 4 Gleason 4+5 / 5+4=9

High risk · Selective focal, MDT required

Grade Group 5 Gleason 5+5=10

Very high risk · Focal therapy generally not indicated

Positive Cores on Biopsy

          Report targeted cores (MRI-fusion) and systematic cores separately where available. Extensive core positivity suggests disease burden beyond the index lesion, complicating focal ablation zone selection and raising the risk of leaving significant disease untreated.
        

Targeted (MRI-fusion) Cores

1 of 2 positive

Single targeted core involved · Focal lesion well-characterised · Low volume index lesion likely

2 of 2 positive

Both targeted cores positive · Higher lesion volume implied · Ensure MRI diameter accurately captures full extent

Systematic Cores — Ipsilateral Lobe

1–2 of 6 positive

Low systematic burden · Disease likely confined to index lesion territory

3–4 of 6 positive

Moderate systematic involvement · Wider ablation zone may be required · Correlate with MRI and Unfold AI mapping

5–6 of 6 positive

Extensive ipsilateral systematic involvement · Hemi-gland or whole-gland treatment may be more appropriate · Focal ablation risks significant residual disease

Systematic Cores — Contralateral Lobe

Negative — No contralateral involvement

Contralateral lobe clear on systematic biopsy · Supports unilateral focal approach

1–2 cores positive — GG1 or low-volume GG2

Minor contralateral involvement · May be accepted as index lesion–only focal if GG1 and < 3 mm · Requires careful discussion — some centres extend to hemi-gland in this scenario

≥ 2 cores positive — GG2 or higher contralaterally

Significant contralateral disease · Bilateral focal or whole-gland treatment should be considered · Unilateral focal ablation is unlikely to be adequate

% Pattern 4 (Cribriform / Non-cribriform)

          Quantitative pattern 4 percentage within GG2 and GG3 cancers refines risk beyond the grade group alone. Cribriform and intraductal carcinoma patterns carry the worst prognosis within GG2. High % pattern 4 is independently associated with adverse pathology and biochemical recurrence after focal therapy.
        

Not applicable — GG1 (no pattern 4)

Pure Gleason 3+3 · No pattern 4 present · Lowest oncologic risk

< 10% Pattern 4

Minimal pattern 4 burden · Favourable within GG2 · Risk stratification similar to GG1 in some nomograms

10–50% Pattern 4 — Non-cribriform

Moderate pattern 4 without cribriform architecture · Intermediate risk within GG2/3 · Standard focal therapy margins apply

10–50% Pattern 4 — With cribriform architecture

Cribriform pattern 4 is an independent adverse prognostic marker · Associated with higher ECE risk and worse oncologic outcomes after focal therapy · Consider wider margins and MDT review

> 50% Pattern 4 — Non-cribriform

Dominant pattern 4 burden · Equivalent to GG3 behaviour in many series · Focal therapy requires careful patient counselling on oncologic risk · MDT discussion recommended

> 50% Pattern 4 — With cribriform architecture or intraductal carcinoma

Highest risk within GG2/3 · Cribriform or IDC pattern with dominant pattern 4 — equivalent to GG3/4 prognosis in multiple studies · Whole-gland treatment or MDT review strongly recommended before proceeding with focal therapy

A+E

Tumor Size & Extracapsular Risk

Index lesion diameter · ECE / T-stage · Prostate volume

0 pts

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Index Lesion Maximum Diameter

≤ 15 mm

16–25 mm

> 25 mm

Extracapsular Extension (ECE) / T-Stage

None (T2)

Suspected T3a (ECE)

Confirmed T3b (SVI)

Prostate Volume

< 40 cc

40–80 cc

> 80 cc

Anatomical Complexity Factors

Urethral architecture · Pubic arch · Calcifications · HIFU focal depth

0 pts

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Urethral Architecture

Normal

Deviated / BPH

Stricture / Prior TURP

Pubic Arch Interference (for HIFU / TULSA)

None

Partial (< 25% shadow)

Significant (> 25% shadow)

Calcifications, Fiducial Markers or Brachytherapy Seeds in Treatment Field

          All dense hyperechoic / hyperdense objects cause acoustic shadowing for HIFU/TULSA and arc artefact for MR-guided systems. Brachytherapy seeds are particularly problematic — multiple seeds cause confluent shadowing and may render thermal mapping unreliable.
        

None

No calcifications, markers or seeds in field

Minor — calcification < 5 mm or 1–2 fiducial markers

Limited shadowing · Ablation planning can accommodate

Moderate — calcification ≥ 5 mm or ≥ 3 fiducial markers

Significant shadowing · HIFU/TULSA accuracy reduced · IRE unaffected

Severe — prior brachytherapy seeds in treatment field

Confluent shadowing · Thermal mapping unreliable · HIFU/TULSA strongly cautioned

HIFU Focal Depth — Distance from Rectal Transducer to Index Lesion HIFU ONLY

          Measured from the centre of the rectal lumen (transducer nucleus) to the far edge of the index lesion on axial MRI. HIFU effective focal range ≤ 40 mm. Beyond this, sonication energy is insufficient for reliable ablation.
        

< 25 mm

Optimal focal depth · Full sonication power available

25–35 mm

Acceptable range · May require extended treatment time

35–40 mm

Near limit · Reduced energy delivery · Ablation margins at risk

> 40 mm

Beyond HIFU focal range · HIFU contraindicated for this lesion

♡

Functional Baseline & Quality of Life

Lower urinary tract · Continence · Erectile function · Bowel function

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        Pre-treatment functional status is the strongest predictor of post-focal therapy outcomes. Baseline assessment using validated instruments is essential for informed consent, treatment planning, and post-treatment comparison. Domains affected vary by modality — findings here are used to contextualise risk, not to exclude patients from treatment.
      

        01 · Lower Urinary Tract Symptoms (LUTS)
      

IPSS — International Prostate Symptom Score

          7-item validated questionnaire covering urinary frequency, urgency, nocturia, weak stream, hesitancy, incomplete emptying, and intermittency. Score 0–35. Obstructive LUTS pre-treatment predicts acute retention and prolonged catheterisation post-procedure, particularly with TULSA and HIFU.
        

Mild — IPSS 0–7

Minimal or no voiding symptoms · Low risk of post-procedure urinary retention

0–7

Moderate — IPSS 8–19

Significant voiding symptoms present · Medical optimisation (alpha-blocker / 5-ARI) before procedure recommended · Monitor post-op voiding carefully

8–19

Severe — IPSS 20–35

Severe obstructive symptoms · High retention risk · Urodynamics recommended before proceeding · TULSA highest periurethral risk · May represent exclusion criterion (see Exclusion Criteria section)

20–35

Peak Urinary Flow Rate (Qmax) & Post-Void Residual (PVR)

Normal — Qmax ≥ 15 mL/s & PVR < 50 mL

Adequate bladder outflow · Proceed with standard protocol

✓

Borderline — Qmax 10–15 mL/s or PVR 50–150 mL

Reduced flow or incomplete emptying · Consider pre-treatment alpha-blocker · Enhanced post-procedure catheter protocol

⚡

Impaired — Qmax < 10 mL/s or PVR > 150 mL

Obstructed or failing bladder · Urodynamics mandatory · See exclusion criteria — may be relative or absolute contraindication depending on severity

        02 · Urinary Continence
      

ICIQ-UI SF — Incontinence Severity & Continence Status

          Validated 3-item instrument scoring frequency, volume, and impact of urinary leakage (0–21). Pre-treatment continence is a primary determinant of outcome reporting and patient satisfaction post-focal therapy. Sphincter integrity (dEUS) is the anatomic correlate — see P+S section.
        

Fully continent — ICIQ-UI 0

No urinary leakage · Baseline fully preserved · Optimal candidate for functional outcome tracking

✓

Mild leakage — ICIQ-UI 1–5

Occasional stress or urgency leakage · Socially continent · Inform patient that focal therapy may worsen continence particularly with apical lesions

1–5

Moderate leakage — ICIQ-UI 6–12

Regular leakage with moderate impact · Baseline already impaired · Must be clearly discussed in informed consent · Any apical treatment carries significant additional SUI risk

6–12

Severe leakage — ICIQ-UI 13–21

Severe baseline incontinence · Focal therapy unlikely to improve and may significantly worsen continence · Specialist continence / pelvic floor review recommended before proceeding

13–21

        03 · Erectile Function
      

IIEF-5 / SHIM — Erectile Function Domain

          5-item abridged International Index of Erectile Function (score 5–25). Preservation of erection is a primary advantage of focal therapy over radical prostatectomy. However, apical and posterolateral lesions near the NVBs remain at risk — correlate with NVB proximity score. PDE5i use and penile rehabilitation should be discussed pre-treatment.
        

No dysfunction — IIEF-5 22–25

Normal erectile function · Preservation is a key treatment goal · Discuss NVB proximity and modality-specific risk at consent

22–25

Mild dysfunction — IIEF-5 17–21

Mild ED present at baseline · Pen rehabilitation and PDE5i should be initiated peri-treatment · Reasonable expectation of maintenance if NVBs spared

17–21

Mild-moderate dysfunction — IIEF-5 12–16

Moderate pre-treatment ED · PDE5i optimisation before focal therapy recommended · Lower expectation of significant improvement post-treatment · NVB-sparing approach important

12–16

Moderate-severe dysfunction — IIEF-5 8–11

Significant pre-treatment dysfunction · Focal therapy unlikely to improve erections · Counsel patient accordingly · ED preservation advantage of focal therapy over RP is reduced in this domain

8–11

Severe dysfunction / Non-functional — IIEF-5 5–7

Erectile function severely impaired at baseline · NVB preservation no longer a primary treatment driver · ED advantage of focal therapy over RP is absent · Discuss realistic expectations · Investigate reversible causes (testosterone, vascular)

5–7

PDE5 Inhibitor / Penile Rehabilitation Status

Not on PDE5i — No current rehabilitation

Consider initiating sildenafil/tadalafil peri-treatment if NVBs in treatment field · Early pharmacological rehabilitation improves erectile recovery

—

On PDE5i — Responsive (adequate erections with medication)

Continue perioperatively · Good prognosis for maintained function if NVBs preserved · Document dosing for baseline

✓

On PDE5i — Non-responsive / Requires ICI or device

Advanced penile rehabilitation already required · Realistic counselling essential · Penile prosthesis planning may be appropriate regardless of focal therapy outcome

⚠

        04 · Bowel Function
      

Baseline Bowel Function — EPIC-26 Bowel Domain / Clinical Assessment

          Rectal injury is rare with focal therapy but catastrophic when it occurs (recto-urethral fistula). Baseline bowel function establishes prior rectal symptoms and determines healing capacity. EPIC-26 bowel domain scores urgency, frequency, leakage, haemorrhage, and bother on a 0–100 scale (higher = better function).
        

No bowel symptoms — EPIC-26 Bowel ≥ 90

Normal rectal function · Proceed with standard approach · Rectal wall proximity (P+S) is key anatomic determinant of risk

✓

Mild symptoms — EPIC-26 Bowel 70–89

Minor rectal symptoms at baseline · Document clearly · Inform patient of small additional fistula risk · Rectal cooling (TULSA ECD) or rectal spacing important

70–89

Moderate symptoms — EPIC-26 Bowel 50–69

Established rectal symptoms · Risk of worsening with posterior thermal treatments · Colonoscopy / gastroenterology review recommended · Rectal wall proximity particularly important in this group

50–69

Severe symptoms — EPIC-26 Bowel < 50

Severely compromised rectal function · High risk of fistula or worsening rectal injury with posterior thermal or cryo ablation · Consider non-posterior approach (anterior lesions, IRE) · Gastroenterology and colorectal surgery input required

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        05 · Treatment Intent & Prior Therapy History
      

Treatment Intent

          Determines the clinical context for focal therapy. Primary focal therapy is delivered to treatment-naïve patients. Salvage focal therapy targets biopsy-confirmed recurrence after a prior definitive treatment — technical complexity, complication risk, and modality suitability differ substantially between these two settings.
        

Primary — Treatment-naïve prostate cancer

No prior definitive local therapy · Standard focal therapy indication · All modalities potentially applicable subject to anatomic scoring

Primary

Salvage — Biopsy-confirmed recurrence after prior definitive treatment

Prior local therapy has altered tissue planes, vascularity, and healing capacity · Salvage focal therapy requires specialist MDT review · Specify prior treatment type below

Salvage

Prior Radiation Therapy SALVAGE ONLY

          Prior radiation induces fibrosis, reduced vascularity, impaired tissue healing, and cumulative rectal dose that dramatically increases fistula risk with thermal focal therapy. The specific radiation modality and dose delivered determines residual tissue tolerance.
        

No prior radiation

Radiation-naïve prostate and rectum · Normal healing capacity and rectal tissue tolerance

✓

Prior EBRT (External Beam Radiotherapy)

Conventionally fractionated or moderately hypofractionated EBRT (e.g. 74–78 Gy / 20 fx) · Diffuse prostate and rectal fibrosis expected · Recto-urethral fistula risk elevated with posterior thermal ablation · Confirm total rectal dose and radiation proctitis grade before planning

⚠

Prior SBRT / SABR (Stereotactic Body Radiotherapy)

High ablative dose-per-fraction (e.g. 35–40 Gy / 5 fx) · Concentrated tissue damage at target · Rectal hotspot dose may be higher than conventional EBRT relative to volume · Late rectal toxicity risk significant · Tissue necrosis risk with re-treatment is high

⚠⚠

Prior LDR Brachytherapy (Permanent seeds — I-125 / Pd-103)

Seeds remain in situ · Confluent ultrasound shadowing severely limits HIFU and TULSA treatment planning · IRE unaffected by seeds · Seed map essential for treatment planning · Check Cx section — calcification/seed scoring required

⚠⚠

Prior HDR Brachytherapy (Temporary high-dose rate)

No seeds remaining · High focal dose delivered to prostate · Periurethral and perirectal dose may be high depending on plan geometry · Tissue fibrosis concentrated around implant tracks · Obtain original dosimetry records

⚠

Prior Focal Therapy SALVAGE ONLY

          Repeat focal therapy after in-field recurrence is technically feasible but carries higher complication risk than primary treatment due to treated zone fibrosis, altered tissue planes, and cumulative thermal load near critical structures. Out-of-field recurrence in untreated areas may be treated with lower additional risk.
        

No prior focal therapy

Treatment-naïve prostate tissue in target zone · Standard tissue characteristics expected

✓

Prior HIFU — In-field recurrence (same zone)

Hyperechoic scar and fibrosis in treated zone · HIFU re-treatment technically feasible but increased risk · Altered tissue echogenicity may compromise targeting accuracy · Periurethral and rectal structures at cumulative risk

⚠

Prior Cryotherapy — In-field recurrence (same zone)

Dense fibrosis and tissue contraction in treated zone · Needle placement for repeat cryo may be difficult · Iceball propagation less predictable in fibrotic tissue · NVB and urethral structures at elevated cumulative risk · Consider alternative modality

⚠

Prior TULSA-PRO — In-field recurrence (same zone)

Periurethral thermal scar tissue alters MR thermometry signal in re-treatment · TULSA repeat feasible but thermometry calibration requires careful specialist assessment · IRE may be preferable to avoid cumulative periurethral thermal injury

⚠

Prior IRE (NanoKnife) — In-field recurrence (same zone)

Non-thermal — minimal structural fibrosis compared to thermal modalities · Re-treatment with IRE or thermal modality generally feasible · Electrode placement geometry should be reviewed from prior procedure · Lowest cumulative structural change of all focal modalities

Low risk

Prior Focal Laser Ablation (FLA) — In-field recurrence

Small-volume thermal scar · Localised fibrosis confined to needle track zone · Generally favourable tissue characteristics for repeat ablation · Confirm extent of prior treatment on follow-up MRI before planning

Low–Mod

Out-of-field recurrence — Untreated zone (new lesion)

Recurrence is in a prostate zone not previously treated · Target tissue is essentially naïve · Complication risk similar to primary focal therapy · Confirm on MRI and re-biopsy that prior treatment zone is clear

✓

Clinical Flags & Alerts

Complete the scoring to see flags.

Important Disclaimer This tool is intended as a clinical decision support aid only and does not replace individualized patient assessment, multidisciplinary team review, or the clinical judgment of an experienced urologist or interventional oncologist. Modality selection must incorporate PSA, biopsy grade, MRI quality, patient comorbidities, and institutional expertise. Score thresholds are based on expert consensus principles analogous to the RENAL nephrometry framework and should be validated prospectively before use in clinical protocols.

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PROSTATE Score