EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer 2020
Summary of changes
The literature for the complete document has been assessed and updated based upon a review of all recommendations and creation of appropriate GRADE forms. Evidence summaries and recommendations have been amended throughout the current document and several new sections have been added.
The following sections have been revised, or were added:
- Section 3.2.1 - Family history/genetics, has been updated resulting in a new recommendation.
5.1.3 Guidelines for screening and early detection
| Recommendation for all patients | LE | Strength rating |
Offer early PSA testing to well-informed men at elevated risk of having PCa: • men carrying BRCA2 mutations > 40 years of age. | 2b
| Strong |
- Chapter 4 - Classification and staging systems, including two recommendations.
4.4 Guideline for classification and staging systems
| Recommendations | Strength rating |
| Use the Tumour, Node, Metastasis (TNM) classification for staging of PCa. | Strong |
| Use the International Society of Urological Pathology (ISUP) 2014 system for grading of PCa. | Strong |
- Section 5.2.4.2.7.3 - The role of risk-stratification, has been revised with the inclusion of a new table (Table 5.2.4.2: Impact of the PSA density on csPCa detection rates in patients with negative mpMRI findings) and amended recommendations.
5.2.4.4 Guidelines for imaging in PCa detection
| Introductory statement | LE |
| Systematic biopsy is an acceptable approach in case mpMRI is unavailable. | 3 |
| Recommendation for all patients | LE | Strength rating |
| Do not use mpMRI as an initial screening tool. | 3 | Strong |
| Adhere to PI-RADS guidelines for multiparametric magnetic resonance imaging (mpMRI) acquisition and interpretation and evaluate mpMRI results in multidisciplinary meetings with pathological feedback. | 3 | Strong |
- Section 5.3.2.3 - Prostate-specific membrane antigen-based PET/CT, has been completely revised.
- Section - 5.2.7.3 Tissue-based prognostic biomarker testing includes the findings of a recently published multidisciplinary Guideline, resulting in one recommendation to be changed from ‘Strong’ to ‘Weak’.
5.2.2.6 Guidelines for risk-assessment of asymptomatic men
| Recommendations | Strength rating |
To avoid unnecessary biopsies, offer further risk-assessment to asymptomatic men with a normal digital rectal examination and a prostate-specific antigen level between 2-10 ng/mL prior to performing a prostate biopsy. Use one of the following tools: • an additional serum or urine-based test. | Weak |
- Chapter 5.2 - Clinical diagnosis, in particular Section 5.2.6 - Prostate biopsy procedure, was amended resulting in a changed recommendation.
5.2.8 Guidelines for the clinical diagnosis of prostate cancer
| Recommendations for all patients | LE | Strength rating |
| Do not offer non-targeted transition zone sampling at initial biopsies due to low detection rates. | 2b | Weak |
- Section 6.1.2 - Radical prostatectomy, has been completely revised.
- Section 6.1.3.1.3 - Hypofractionation, was revised, also including a new table (Table 6.1.8: Selected trials on hypofractionation for intact localised PCa).
- Section 6.2.1 - Treatment of low-risk disease; the findings of an international collaborative multi-stakeholder consensus project addressing the deferred treatment with curative intent for localised have been incorporated, resulting in several changes to the recommendations for this section. New sections 6.2.1.1.3 - Imaging for treatment selection, 6.2.1.1.4 - Monitoring during active surveillance, and 6.2.1.1.5 - Active surveillance, when to change strategy, have been added. Due to the inclusion of new data, new sections and the findings of the international collaborative multi-stakeholder consensus project addressing the deferred treatment with curative intent for localised PCa, a number of recommendations were changed, and new recommendations have been added.
6.2.1.4 Guidelines for the treatment of low-risk disease
| Recommendations | Strength rating |
| Active surveillance (AS) | |
| Offer AS to patients with a life expectancy > 10 years and low-risk disease. | Strong |
| If a patient has had upfront multiparametric magnetic resonance imaging (mpMRI) followed by systematic and targeted biopsies there is no need for confirmatory biopsies. | Weak |
| Patients with intraductal and cribiform histology on biopsy should be excluded from AS. | Strong |
| If required perform mpMRI before a confirmatory biopsy. | Strong |
| Take both targeted biopsy (of any PI-RADS > 3 lesion) and systematic biopsy if a confirmatory biopsy is performed. | Strong |
| Perform serum prostate-specific antigen (PSA) assessment every 6 months. | Strong |
| Perform digital rectal examination (DRE) every 12 months. | Strong |
| Repeat biopsy should be performed if there is evidence of PSA progression, clinical progression on DRE or radiological progression on mpMRI. | Strong |
| During follow-up, if mpMRI is negative (i.e., PI-RADS ≤ 2), and clinical suspicion of prostate cancer progression is low (e.g. low PSA velocity, long PSA doubling time), omit biopsy based on shared decision making with the patient. | Weak |
| Counsel patients about the possibility of needing further treatment in the future. | Strong |
| Other therapeutic options | |
| Only offer whole gland treatment (such as cryotherapy, high-intensity focused ultrasound, etc.) or focal treatment within a clinical trial setting or well-designed prospective cohort study. | Strong |
- 6.2.2.4 - Other options for the primary treatment of intermediate-risk PCa (experimental therapies), has been revised.
- Section 6.2.3 - Treatment of high-risk localised disease; due to the inclusion of new data, a recommendation was revised.
6.2.4.4 Guidelines for radical treatment of high-risk localised disease
| Recommendation | Strength rating |
| Radical Prostatectomy (RP) | |
| Offer RP to selected patients with high-risk localised PCa, as part of potential multimodal therapy. | Strong |
- Section 6.2.4 - Treatment of locally-advanced prostate cancer, has been revised, also including a new section on the treatment of cN1 disease, resulting in a new recommendation:
6.2.4.5 Guidelines for radical treatment of locally-advanced disease
| Recommendations | Strength rating |
| Radiotherapeutic treatments | |
| Offer long-term ADT for at least two years. | Weak |
| Therapeutic options outside surgery and radiotherapy | |
| Only offer ADT monotherapy to those patients unwilling or unable to receive any form of local treatment if they have a prostate-specific antigen (PSA)-doubling time < 12 months, and either a PSA > 50 ng/mL, a poorly-differentiated tumour or troublesome local disease-related symptoms. | Strong |
| Offer patients with cN1 disease a local treatment (either RP or external beam radiation therapy) plus long-term ADT. | Weak |
- Section 6.2.5 - Adjuvant treatment after radical prostatectomy, due to the inclusion of new data, two recommendations were revised.
6.2.5.6 Guidelines for adjuvant treatment options after radical prostatectomy
| Recommendations | Strength rating |
| Offer adjuvant external-beam radiation therapy to the surgical field to highly selected patients. | Strong |
Discuss three management options with patients with pN+ disease after an extended lymph node dissection, based on nodal involvement characteristics: 1. Offer adjuvant ADT; 2. Offer adjuvant ADT with additional radiotherapy; 3. Offer observation (expectant management) to a patient after eLND and ≤ 2 nodes with microscopic involvement, and a PSA < 0.1 ng/mL and absence of extranodal extension. | Weak |
- Section 6.3.4 - The role of imaging in PSA-only recurrence, has been completely revised.
- Due to the inclusion of new data in the second-line treatment modalities, two recommendations have been added.
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 PSA monitoring to patients with biochemical recurrence with low-risk features at relapse who may not benefit from intervention. | Weak
|
| Offer hormonal therapy in addition to SRT to men with biochemical recurrence. | Weak |
- Section 6.4 - Treatment of metastatic prostate cancer, has been considerably revised with additional data (including new Section - 6.4.4.2.2 - Combination with the new hormonal treatments [abiraterone, ezalutamide]) and the inclusion of a new table (Table 6.4.5: Results from the ENZAMET and TITAN studies), necessitating changes to the recommendations.
6.4.9 Guidelines for the first-line treatment of metastatic disease
| Recommendations | Strength rating |
| Offer immediate systemic treatment with androgen deprivation therapy (ADT) to palliate symptoms and reduce the risk for potentially serious sequelae of advanced disease (spinal cord compression, pathological fractures, ureteral obstruction) to M1 symptomatic patients. | Strong |
| Offer luteinising hormone-releasing hormone (LHRH) antagonists, especially to patients with an impending spinal cord compression or bladder outlet obstruction. | Weak |
| 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 immediate systemic treatment to M1 patients asymptomatic from their tumour. | Weak |
| Discuss deferred ADT with well-informed M1 patients asymptomatic from their tumour since it lowers the treatment-related side-effects, provided the patient is closely monitored. | Weak |
| Offer short-term administration of an older generation androgen receptor (AR) antagonist to M1 patients starting LHRH agonist to reduce the risk of the ‘flare-up’ phenomenon. | Weak |
| Do not offer AR antagonists monotherapy to patients with M1 disease. | Strong |
| Offer ADT combined with chemotherapy (docetaxel) to patients whose first presentation is M1 disease and who are fit for docetaxel. | Strong |
| Offer ADT combined with abiraterone acetate plus prednisone or apalutamide or enzalutamide to patients whose first presentation is M1 disease and who are fit for the regimen. | Strong |
| Offer ADT combined with prostate radiotherapy to patients whose first presentation is M1 disease and who have low volume of disease by CHAARTED criteria. | Strong |
| Do not offer ADT combined with any local treatment (radiotherapy/surgery) to patients with high volume (CHAARTED criteria) M1 disease outside of clinical trials (except for symptom control). | Strong |
- Section 6.5 - Treatment; Castration-resistant PCa, has been updated, also including additional information general aspects (Section 6.5.1.2) and sequencing of drugs. New section 6.5.7 - Gallium prostate specific membrane antigen (PSMA) therapy, has been included. Recommendations were changed in sections:
6.5.13 Summary of evidence and guidelines for life-prolonging treatments of castrate-resistant disease
| Recommendation | Strength rating |
Treat patients with mCRPC with life-prolonging agents. Base the choice of first-line treatment on the performance status, symptoms, comorbidities, location and extent of disease, patient preference, and on the previous treatment for hormone-sensitive metastatic PCa (HSPC) (alphabetical order: abiraterone, cabazitaxel, docetaxel, enzalutamide, radium-223, sipuleucel-T). | Strong
|
6.5.15 Guidelines for supportive care of castrate-resistant disease
| Recommendation | Strength rating |
| Monitor serum calcium and offer calcium and vitamin D supplementation when prescribing either denosumab or bisphosphonates. | Strong |
6.5.16 Guidelines for non-metastatic castrate-resistant disease
| Recommendation | Strength rating |
| Offer apalutamide, darolutamide or enzalutamide to patients with M0 CRPC and a high risk of developing metastasis (PSA-DT < 10 months) to prolong time to metastases. | Strong |
- Chapter 7 - Follow-up, aside from revised data, includes new section 7.2.6 - Disease progression during androgen deprivation therapy.
- Due to the inclusion of new publications, new recommendations were added to Chapter 8 - Quality of life outcomes in prostate cancer:
8.3.1.2 Guidelines for quality of life in men undergoing systemic treatments
| Recommendation | 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. Ensure that calcium and vitamin D meet recommended levels. | Strong |
8.3.2.1 Guidelines for quality of life in men undergoing systemic treatments
| Recommendation | Strength rating |
| Offer men starting on long-term androgen deprivation therapy dual emission X-ray absorptiometry (DEXA) scanning to assess bone mineral density. | Strong |
| Use the WHO FRAX tool to guide monitoring and treatment of bone mineral density in men on long term ADT. | Strong |