Prostate Cancer

Full Text Guidelines Summary of Changes Scientific Publications & Appendices Pocket Guidelines Archive Panel

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N. Mottet (Chair), R.C.N. van den Bergh, E. Briers (Patient Representative), P. Cornford (Vice-chair), M. De Santis, S. Fanti, S. Gillessen, J. Grummet, A.M. Henry, T.B. Lam, M.D. Mason, T.H. van der Kwast, H.G. van der Poel, O. Rouvière, D. Tilki, T. Wiegel
Guidelines Associates: T. Van den Broeck, M. Cumberbatch, N. Fossati, T. Gross, M. Lardas, M. Liew, L. Moris, I.G. Schoots, P-P.M. Willemse

1.INTRODUCTION

1.1.Aims and scope

The Prostate Cancer (PCa) Guidelines Panel have prepared this guidelines document to assist medical professionals in the evidence-based management of PCa.

It must be emphasised that clinical guidelines present the best evidence available to the experts but following guideline recommendations will not necessarily result in the best outcome. Guidelines can never replace clinical expertise when making treatment decisions for individual patients, but rather help to focus decisions - also taking personal values and preferences/individual circumstances of patients into account. Guidelines are not mandates and do not purport to be a legal standard of care.

1.2.Panel composition

The PCa Guidelines Panel consists of an international multidisciplinary group of urologists, radiation oncologists, medical oncologists, radiologists, a pathologist and a patient representative.

All imaging sections in the text have been developed jointly with the European Society of Urogenital Radiology (ESUR) and the European Association of Nuclear Medicine (EANM). Representatives of the ESUR and the EANM in the PCa Guidelines Panel are (in alphabetical order): Prof.Dr. S. Fanti, Prof.Dr. O Rouvière and
Dr. I.G. Schoots.

All radiotherapy sections have been developed jointly with the European Society for Radiotherapy & Oncology (ESTRO). Representatives of ESTRO in the PCa Guidelines Panel are (in alphabetical order):
Prof.Dr. A.M. Henry, Prof.Dr. M.D. Mason and Prof.Dr. T. Wiegel.

All experts involved in the production of this document have submitted potential conflict of interest statements which can be viewed on the EAU website Uroweb:
http://uroweb.org/guideline/prostate-cancer/?type=panel.

1.2.1.Acknowledgement

The PCa Guidelines Panel gratefully acknowledges the assistance and general guidance provided by Prof.Dr. M. Bolla, honorary member of the PCa Guidelines Panel.

1.3.Available publications

A quick reference document (Pocket guidelines) is available, both in print and as an app for iOS and Android devices. These are abridged versions which may require consultation together with the full text version. Several scientific publications are available [1,2] as are a number of translations of all versions of the PCa Guidelines. All documents can be accessed on the EAU website: http://uroweb.org/guideline/prostate-cancer/.

1.4.Publication history and summary of changes

1.4.1.Publication history

The EAU PCa Guidelines were first published in 2001. This 2019 document presents a full update of the 2018 PCa Guidelines publication.

1.4.2.Summary of changes

The literature for the complete document has been assessed and updated, where relevant. Evidence summaries and recommendations have been amended throughout the current document and several new sections have been added.


  • Section 5.2.4 – The role of multiparametric magnetic resonance imaging (mpMRI) in clinical diagnosis, has been completely revised, also including data from a recent Cochrane review [1]. As a result new recommendations for imaging have been provided throughout these guidelines.

5.2.4.8 Summary of evidence and guidelines for diagnostic imaging

Summary of evidence

LE

Systematic biopsy is an acceptable approach if mpMRI is unavailable.

3

Recommendations for all patients

LE

Strength rating

Do not use mpMRI as an initial screening tool.

3

Strong

Adhere to PI-RADS guidelines for mpMRI acquisition and interpretation.

3

Strong

Recommendations in biopsy-naïve patients

LE

Strength rating

Perform mpMRI before prostate biopsy.

1a

Weak

When mpMRI is positive (i.e. PI-RADS > 3), combine targeted and systematic biopsy.

2a

Strong

When mpMRI is negative (i.e. PI-RADS < 2), and clinical suspicion of prostate cancer is low, omit biopsy based on shared decision making with the patient.

2a

Weak

Recommendations in patients with prior negative biopsy

LE

Strength rating

Perform mpMRI before prostate biopsy.

1a

Strong

When mpMRI is positive (i.e. PI-RADS > 3), perform targeted biopsy only.

2a

Weak

When mpMRI is negative (i.e. PI-RADS < 2), and clinical suspicion of prostate cancer is high, perform systematic biopsy based on shared decision making with the patient.

2a

Strong

5.3.5 Guidelines for staging of prostate cancer

Any risk group staging

LE

Strength rating

Use pre-biopsy mpMRI for staging information.

2a

Weak


  • The literature for Section 5.4 – Evaluation of health status and life expectancy, has been updated, resulting in an additional recommendation.

5.4.5 Guidelines for evaluating health status and life expectancy

Recommendations

Strength rating

Use individual life expectancy, health status, and comorbidity to guide PCa management.

Strong


  • Due to the comprehensive revision of all imaging sections, recommendations for imaging for a number of text sections have been changed, or added to.

6.2.1.1.3.3 Guidelines for imaging in men on active surveillance

Recommendations in men on active surveillance

LE

Strength rating

Perform multiparametric magnetic resonance imaging before a confirmatory prostate biopsy, if not done before the first biopsy.

1a

Strong

Perform the combination of targeted biopsy (of any PI-RADS > 3 lesion) and systematic biopsy at confirmatory biopsy.

2a

Weak

6.2.1.4 Guidelines for the treatment of low-risk disease

Recommendations

Strength rating

Active surveillance (AS)

Perform multiparametric magnetic resonance imaging before a confirmatory biopsy, if not done before the first biopsy.

Strong

Perform the combination of targeted biopsy (of any PI-RADS > 3 lesion) and systematic biopsy at confirmatory biopsy.

Weak

6.2.2.5 Guidelines for the treatment of intermediate-risk disease

Recommendations

Strength rating

Radiotherapeutic treatment

For external-beam radiation therapy (EBRT), use a total dose of 76-78 Gy or moderate hypofractionation (60 Gy/20 fx in four weeks or 70 Gy/28 fx in six weeks), in combination with short-term neoadjuvant plus concomitant androgen deprivation therapy (ADT) (four to six months).

Strong

Other therapeutic options

Do not offer ADT monotherapy to intermediate-risk asymptomatic men unable to receive any local treatment.

Strong


  • A new text Section 6.2.6 - Persistent PSA after radical prostatectomy, has been added.

6.2.6.6 Recommendations for the management of persistent PSA after radical prostatectomy

Recommendations

Strength rating

Offer a prostate-specific membrane antigen positron emission tomography (PSMA PET) scan to men with a persistent PSA > 0.2 ng/mL to exclude metastatic disease.

Weak

Treat men with no evidence of metastatic disease with salvage radiotherapy and additional hormonal therapy.

Weak

6.3.4.4 Guidelines for imaging in patients with biochemical recurrence

Prostate-specific antigen (PSA) recurrence after radical prostatectomy

LE

Strength rating

Perform PSMA PET/CT if the PSA level is > 0.2 ng/mL and if the results will influence subsequent treatment decisions.

2b

Weak

In case PSMA PET/CT is not available, and the PSA level is > 1 ng/mL, perform Fluciclovine PET/CT or Choline PET/CT imaging if the results will influence subsequent treatment decisions.

Weak

PSA recurrence after radiotherapy

Perform prostate multiparametric magnetic resonance imaging to localise abnormal areas and guide biopsies in patients fit for local salvage therapy.

3

Strong

Perform PSMA PET/CT (if available) or fluciclovine PET/CT or choline PET/CT in patients fit for curative salvage treatment.

2b

Strong


  • Section 6.3 - Management of PSA-only recurrence after treatment with curative intent, has been completely revised, introducing the concept of patient stratification into EAU low- and high-risk recurrence groups based on the findings of a systematic review (SR). New recommendations have been provided.

6.3.9 Guidelines for second-line therapy after treatment with curative intent

Local salvage treatment

Strength rating

Recommendations for biochemical recurrence after radical prostatectomy

Offer active surveillance and possibly delayed salvage radiotherapy (SRT) to patients with biochemical recurrence and classified as EAU low-risk group at relapse who may not benefit from intervention.

Strong

Treat patients with a PSA rise from the undetectable range with SRT. Once the decision for SRT has been made, SRT (at least 66 Gy) should be given as soon as possible.

Strong

Offer pN0 patients undergoing SRT hormonal therapy (with bicalutamide 150 mg for two years, or LHRH agonists for up to two years).

Weak

Do not offer hormonal therapy to every pN0 patient treated with SRT.

Strong


  • Based on the complete update of Section 6.4 - Metastatic prostate cancer, new recommendations have been included.

6.4.9 Guidelines for the first-line treatment of metastatic disease

Recommendations

Strength rating

Offer surgery and/or local radiotherapy to any patient with M1 disease and evidence of impending complications such as spinal cord compression or pathological fracture.

Strong

Offer castration combined with prostate radiotherapy to patients whose first presentation is M1 disease and who have low volume of disease by CHAARTED criteria.

Weak

Offer castration alone, with or without an anti-androgen, to patients unfit for, or unwilling to consider, castration combined with docetaxel or abiraterone acetate plus prednisone or prostate radiotherapy.

Strong

6.5.14 Guidelines for non-metastatic castrate-resistant disease

Recommendation

Strength rating

Offer apalutamide or enzalutamide to patients with M0 CRPC and a high risk of developing metastasis (PSA-DT < 10 months) to prolong time to metastases.

Strong

8.3.2.1 Guidelines for quality of life in men undergoing systemic treatments

Recommendations

Strength rating

Advise men on androgen deprivation therapy to maintain a healthy weight and diet, to stop smoking and have yearly screening for diabetes and hypercholesterolemia. Supplementation with vitamin D and calcium is advised.

Strong

Specific sections of the text have been updated based on SR questions prioritised by the Guidelines Panel. These reviews were performed using standard Cochrane SR methodology;
http://www.cochranelibrary.com/about/about-cochrane-systematic-reviews.html:


  • Section 6.3 - Management of PSA-only recurrence after treatment with curative intent [2].