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 . As a result new recommendations for imaging have been provided throughout these guidelines.
184.108.40.206 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.|
|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
|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.
220.127.116.11.3.3 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.|
|Perform the combination of targeted biopsy (of any PI-RADS ≥ 3 lesion) and systematic biopsy at confirmatory biopsy.||2a||Weak|
18.104.22.168 Guidelines for the treatment of low-risk disease
|Active surveillance (AS)|
|Perform multiparametric magnetic resonance imaging before a confirmatory biopsy, if not done before the first biopsy.|
|Perform the combination of targeted biopsy (of any PI-RADS ≥ 3 lesion) and systematic biopsy at confirmatory biopsy.|
22.214.171.124 Guidelines for the treatment of intermediate-risk disease
|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).|
|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.
126.96.36.199 Recommendations for the management of persistent PSA after radical prostatectomy
|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.|
|Treat men with no evidence of metastatic disease with salvage radiotherapy and additional hormonal therapy.|
188.8.131.52 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.|
|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.|
|PSA recurrence after radiotherapy|
|Perform prostate multiparametric magnetic resonance imaging to localise abnormal areas and guide biopsies in patients fit for local salvage therapy.|
|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.|
|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.|
|Offer pN0 patients undergoing SRT hormonal therapy (with bicalutamide 150 mg for two years, or LHRH agonists for up to two years).|
|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
|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.|
|Offer castration combined with prostate radiotherapy to patients whose first presentation is M1 disease and who have low volume of disease by CHAARTED criteria.|
|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.|
6.5.14 Guidelines for non-metastatic castrate-resistant disease
|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.|
184.108.40.206 Guidelines for quality of life in men undergoing systemic treatments
|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.|
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 .