Appendix 2: Results of questionnaires

Items of on which consensus was reached (≥75% agreement) are marked with (*)

General:

What is your profession?
Urologist / 70%
Radiologist / 28%
Other / 2%
With which focal therapy for prostate cancer do you have experience in your personal practice?
HIFU / 58%
Cryotherapy / 50%
Laser Therapy / 26%
Irreversible Electroporation / 16%
Photodynamic Therapy / 24%
Radiofrequency Ablationn / 6%
Focal Brachytherapy / 24%
What do you recommend as the MINIMUM duration for follow-up after Focal Therapy for prostate cancer?
1 year / 2%
2 years / 4%
5 years / 80%*
10 years / 8%
Indefinetely (lifelong) / 4%
Until life expectance < 10 y / 2%
What do you recommend as the OPTIMUM duration for follow-up after focal therapy for prostate cancer in the clinical setting?
10 years / 67%
Indefinately (lifelong) / 28%
Until life expectance < 5 y / 2%
Until life expectance < 10 y / 2%
Treatment success - How do we define ONCOLOGIC TREATMENT SUCCESS after focal therapy? (multiple answers possible)
No cancer on biopsies of the TREATED AREA / 93%*
No significant (high volume, high Gleason) cancer in biopsies of the TREATED AREA / 13%
No cancer in biopsies of the UNTREATED AREA / 17%
No significant (high volume, high Gleason) cancer in biopsies of the UNTREATED AREA / 22%
No cancer suspicion on imaging / 28%
No biochemical recurrence / 30%
No progression to metastatic disease / 28%
No side effects / 7%
Treatment success - How do we define FUNCTIONAL TREATMENT SUCCESS after focal therapy? (multiple answers possible)
No worseling of baseline QoL defined by validated questionnaire / 96%*
No worsening of baseline erections defined by validated questionnaire / 78%*
No worsening of baseline ejaculation / 22%
No worsening of baseline urinary flow defined by uroflowmetry / 24%
No worsening of baseline prostate symptom score defined by validated questionnaire / 67%
No worsening of baseline continence defined by validated questionnaire and/or # of pads / 63%
Abscence of bowel disfunction defined by validated questionnaire / 41%
Other / 2%
Follow-up modalities - Which modalities should be part of follow-up after focal therapy for prostate cancer? / Yes / No / I don't know
Biopsies / 96%* / 0% / 4%
PSA / 98%* / 0% / 2%
Imaging / 92%* / 2% / 6%
Urinary Symptom Score / 96%* / 2% / 2%
Erectile function score / 96%* / 0% / 4%
QoL questionnaire / 98%* / 0% / 2%
Incontinence Symptom Score / 81%* / 9% / 9%
Assesment of incontinence by # of pads / 71% / 17% / 12%
Bowel symptom score / 59% / 24% / 16%
Ejaculation symptom score / 43% / 41% / 16%

Biopsies:

Should biopsies of the TREATED AREA be performed in follow-up of focal therapy? (combination of options possible)
No / 2%
Yes, once at a certain timepoint after the procedure / 54%
Yes, at regular intervals / 26%
Yes, if suspicious areas are seen on imaging / 80%*
yes, in case of a biochemical recurrence / 41%
At what time-point after focal therapy should follow-up biopsy of the TREATED AREA FIRST be performed?
After 3 months / 2%
After 6 months / 35%
After 1 year / 67%
After 2 years / 2%
In case of a biochemical recurrence / 20%
If suspicious areas are seen on imaging / 33%
After the first biopsy, at what INTERVALS after focal therapy should follow-up biopsy of the TREATED AREA be performed?
At 6 months after treatment / 2%
At 1 year after treatment / 4%
At 2 years after treatment / 13%
When suspicious areas are seen on imaging / 91%*
In case of a biochemical recurrence / 52%
In case of an abnormal DRE / 9%
Other / 2%
Should biopsies of the UNTREATED AREA be performed in follow-up of focal therapy?
No / 2%
Yes, once after treatment / 20%
Yes, at regular intervals / 18%
Yes, if suspicious areas are seen on imaging / 84%*
Yes, in case of a biochemical recurrence / 42%
Other / 2%
At what time-point after focal therapy should follow-up biopsy of the UNTREATED AREA FIRST be performed?
Not / 2%
After 6 months / 11%
After 1 year / 59%
After 2 years / 7%
In case of a biochemical recurrence / 33%
If suspicious areas are seen on imaging / 57%
Other / 7%
At what time-point after focal therapy should follow-up biopsy of the UNTREATED AREA FIRST be performed?
Not / 2%
After 6 months / 11%
After 1 year / 59%
After 2 years / 7%
In case of a biochemical recurrence / 33%
If suspicious areas are seen on imaging / 57%
Other / 7%
After the first biopsy, at what INTERVALS after focal therapy should follow-up biopsy of the UNTREATED AREA be performed?
Every 1 year / 7%
Every 2 years / 7%
When suspicious areas are seen on imaging / 93%*
In case of a biochemical recurrence / 48%
In case of an abnormal DRE / 17%
Other / 2%
What is the MINIMAL biopsy scheme for sufficient follow-up after focal therapy?
Template saturation biopsy / 4%
Systematic TRUS biopsy (12x) / 61%
Targeted biopsy of the treated lesion / 33%
Targeted biopsy of the lesions that are suspicious on imaging / 54%
Other / 4%
What is the OPTIMAL biopsy scheme for follow-up after focal therapy?
Template saturation biopsy / 13%
Systematic TRUS biopsy (12x) / 48%
Targeted biopsy of the treated lesion / 52%
Targeted biopsy of the lesions that are suspicious on imaging / 85%*
What are the MINIMUM requirements for follow-up biopsy guidance of the TREATED LESION?
No biopsy needed / 2%
TRUS biopsy / 43%
Contrast Enhanced Ultrasound (CEUS) biopsy / 4%
"computerized" TRUS/MRI Fusion guided biopsy (e.g. UroNav, Artemis, KOELIS) / 15%
"Cognitive TRUS/MRI fusion" (look at MRI and target the approximate area with TRUS) / 46%
MRI guided biopsy / 4%
Any MRI targeting modality / 11%
Transperineal template mapping biopsy / 4%
What are the OPTIMUM requirements for follow-up biopsy guidance of the TREATED LESION?
"computerized" TRUS/MRI Fusion guided biopsy (e.g. UroNav, Artemis, KOELIS) / 85%*
MRI guided biopsy / 7%
Any MRI targeting modality / 7%
Transperineal template mapping biopsy / 2%
What are the MINIMAL requirements for follow-up biopsy of the UNTREATED AREAS in the prostate?
No biopsy needed / 7%
Systematic TRUS biopsy (12x) / 57%
Targeted biopsy when there is a suspicious area on imaging / 17%
Combination of systematic TRUS biopsy (12x) and targeted biopsy in case of suspicion on imaging / 20%
What are the OPTIMAL requirements for follow-up biopsy of the UNTREATED AREAS in the prostate?
Systematic TRUS biopsy (12x) / 2%
Transperineal template mapping biopsy / 4%
Targeted biopsy when there is a suspicious area on imaging / 28%
Combination of systematic TRUS biopsy (12x) and targeted biopsy in case of suspicion on imaging / 65%
Are there limitations/pitfalls of prostate biopsies after focal therapy, we have to take into account?
Yes / No / I don't know
Erectile dysfunction / 30% / 55% / 15%
Contraction/shrikage of the treated area / 68% / 23% / 9%
Bleeding / 51% / 44% / 4%
Infection / 75%* / 21% / 4%
Distortion of imaging modalities / 72% / 17% / 11%
Under-grading due to sampling errors / 58% / 29% / 13%

Digital Ractal Examination:

Should Digital Rectal Examination be part of the folllow-up after focal therapy?
Yes / 80%*
No / 17%
I don't know / 2%

Prostate Specific Antigen (PSA)

Should PSA be a part of the follow-up after Focal Therapy?
Yes / 98%*
No / 2%
When should the FIRST PSA measurement take place after Focal Therapy?
After 3 months / 91%*
After 6 months / 9%
After the first PSA measurement, at which INTERVALS should PSA values be taken after focal therapy of prostate cancer?
Every 3 months / 11%
Every 6 months / 72%
Every year / 4%
After 3 months, 6 months, 1 year, then yearly / 4%
Every 3 months in the first year, then every 6 months / 4%
Every 6 months for 2 years, then yearly / 4%
How do we define biochemical change after focal therapy that would be a trigger for recommending repeat biopsy?
PSA nadir + 1.2 ng/mL (Stuttgart Criteria) / 11%
PSA nadir + 2 ng/mL (Phoenix Criteria) / 20%
2 successive PSA rises after nadir / 13%
3 successive PSA rises after nadir / 7%
Other / 50%
What, do you think are the most important PSA parameter(s) for the follow-up after Focal therapy?
PSA nadir / 41%
Absolute serum PSA concentration / 22%
PSA doubling time / 70%
PSA density / 2%
PSA velocity / 26%
Other / 4%

Imaging:

Which diagnostic imaging modality can be used as stand alone imaging modality for follow-up after focal therapy?
TRUS / 6%
Contrast Enhanced Ultrasound (CEUS) / 13%
Histoscanning / 2%
Multiparametric MRI / 96%*
Other / 2%
Which diagnostic imaging modality is OPTIMAL as stand alone imaging modality for follow-up after focal therapy?
Contrast Enhanced Ultrasound (CEUS) / 2%
Multiparametric MRI / 96%*
Other / 2%
What are the MINIMAL requirements for MP-MRI after focal therapy / yes / no / I don't know
Field strength 1.5T with endorectal coil / 53% / 42% / 5%
Field strength 1.5T without endorectal coil / 45% / 50% / 5%
Field strength 3T with endorectal coil / 30% / 65% / 5%
Field strength 3T without endorectal coil / 56% / 42% / 2%
T2 weighted imaging / 96%* / 2% / 2%
ADC maps of DWI / 93%* / 2% / 4%
DCE imaging / 91%* / 4% / 4%
MR Spectroscopic imaging (MRSI) / 3% / 87% / 11%
T1 weighted imaging / 61% / 24% / 15%
What are the OPTIMAL requirements for MRI imaging after focal therapy? / yes / no / I don't know
Field strength 1.5T with endorectal coil / 38% / 62% / 0%
Field strength 1.5T without endorectal coil / 15% / 85%* / 0%
Field strength 3T with endorectal coil / 66% / 34% / 0%
Field strength 3T without endorectal coil / 74% / 24% / 2%
T2 weighted imaging / 100%* / 0% / 0%
ADC maps of DWI / 100%* / 0% / 0%
DCE imaging / 100%* / 0% / 0%
MR Spectroscopic imaging (MRSI) / 25% / 68% / 8%
T1 weighted imaging / 65% / 23% / 12%
At which timepoint after focal therapy should imaging FIRST be performed to evaluate the ablated region?
The same day / 4%
Within 1-2 weeks after treatment / 7%
3 months after treatment / 7%
6 months after treatment / 76%*
1 year after treatment / 4%
other / 2%
At which timepoint after focal therapy should imaging FIRST be performed to evaluate recurrence?
3 months after treatment / 2%
6 months after treatment / 87%*
1 year after treatment / 11%
After the first imaging session, at which INTERVALS after focal therapy should imaging be performed?
Every year / 13%
ONLY in case of a biochemical recurrence / 4%
Every year AND in case of a biochemical recurrence / 72%
Every 2 years AND in case of a biochemical recurrence / 9%
other / 2%
At which time point after focal therapy can be reliably decided that there was TREATMENT SUCCES on imaging?
Never, one would always need confirmation by targeted biopsy / 15%
After 6 months / 11%
After 1 year / 65%
After 2 years / 2%
After 5 years / 2%
Never / 2%
Other / 2%
How do we define treatment SUCCESS on imaging after focal therapy? Multiple answers possible
No early focal enhancement on DCE in the treated zone / 89%*
No hypo-intense lesion on T2W imaging in the treated zone / 20%
No focal area with diffusion restriction on ADC maps of DWI / 72%
No focal area with high signal intensity on DWI with b-value > 1000 in the treated zone / 65%
Prostate lesion size < 5mm / 9%
No PI-RADS score 3/4/5 / 22%
No PI-RADS score 4/5 / 35%
Other / 2%
At which time point after focal therapy can be reliably decided that there is suspicion for TREATMENT FAILURE on imaging?
Never, one would always need confirmation by targeted biopsy / 11%
After 3 months / 2%
After 6 months / 74%
After 1 year / 13%
How do we define treatment FAILURE on imaging after focal therapy? Multiple answers possible
Early focal enhancement on DCE in the treated zone / 98%*
Hypo-intense lesion on T2W imaging in the treated zone / 20%
Focal area with diffusion restriction on ADC maps of DWI / 72%
Focal area with high signal intensity on DWI with b-value > 1000 in the treated zone / 67%
Prostate volume increases / 2%
PI-RADS score 3/4/5 / 13%
PI-RADS score 4/5 / 50%
What is the most important sequence(s) for detection of recurrent/residual disease after ablation
ADC-maps of Diffusion Weighted Imaging (DWI) / 2%
DWI with b-value> 1000 / 9%
Dynamic Contrast Enhanced Imaging / 93%*
Other / 2%

Quality of life:

Do we need to assess clinical outcome after focal therapy (Urinary symptoms, Flowmetry, Erections, Quality of life) ? / Yes / No / I don't know
Urinary symptoms / 98%* / 2% / 0%
Erections / 98%* / 2% / 0%
Quality of life / 100%* / 0% / 0%
Urolflowmetry / 71% / 18% / 11%
Rectal Symptoms/complications / 87%* / 9% / 4%
Which is the best questionnaire to assess urinary symptoms?
IPSS (International Prostate Symptom Score) / AUA Score / 74%
Combination of IPSS/ AUA and ICS / 4%
EPIC uninary domain / 4%
I don't know / 17%
At which INTERVALS should Urinary symptoms be assessed?
Every 3 months / 9%
Every 6 months / 83%*
Every 1 year / 2%
Every visit / 4%
Only once / 2%
Which is the best questionnaire to assess erectile function?
IIEF-5 (International Index Erectile Function) - 5 / 83%*
IIEF-15 (International Index Erectile Function) - 15 / 4%
I don't know / 13%
At which intervals should erectile function be assessed after focal therapy?
Every 3 months / 4%
Every 6 months / 89%*
Only once / 7%
Which is the best questionnaire to assess quality of life (QoL)?
Expanded Prostate Cancer Index Composite (EPIC) / 26%
University of California – Los Angeles Prostate Cancer Index (UCLA-PCI) / 2%
EORTC QLQ-30 / 9%
I don't know / 63%
At which intervals should quality of life (QoL) be assessed after focal therapy?
Every 3 months / 4%
Every 6 months / 87%
Every 1 year / 2%
Only once / 7%

Complication registration and data pooling:

Should we register complications/ Adverse Events in the follow-up after focal therapy?
Yes / 100%*
No / 0%
Which system should be used for registration of complications?
Clavien-Dindo / 93%*
NCT- CTC (National Cancer Institute Common Toxicity Criteria / 2%
Other / 4%
Is it important for centers that perform focal therapy, to pool their data in a common database?
Yes / 84%*
No / 10%
I don't know / 6%
What would be the pitfalls/ limitations of such a database? Multiple answers are possible
De-identification / 43%
Publication authorships / 53%
Monitoring/ Auditing / 57%
Quality control / 96%*
Lack of common endpoint / 53%
Selection bias / 53%
Diffent modalities of focal therapy / 60%
Other / 4%