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. All chapters of the 2022 PCa Guidelines have been updated. New data have been included in the following sections, resulting in new sections, and new and revised recommendations:
- 4.3 Clinically significant prostate cancer
- 4 5.1.2.4. Risk assessment to determine the need for biopsy
- 4 5.2.1.2 Repeat PSA testingTable 5.5: Risk data table of clinically significant prostate cancer (csPCa), related to PI-RADS score and PSA-D categories in biopsy-naive men, clinically suspected of having significant disease
- Section 5.2.7.1.4 Towards ‘extended’ MRI-directed biopsy?
5.2.3.4 Guidelines for risk-assessment of asymptomatic men
Recommendation | Strength rating |
In asymptomatic men with a prostate-specific antigen (PSA) level between 3–10 ng/mL and a normal digital rectal examination, repeat the PSA test prior to further investigations. | Weak
|
5.2.8 Summery of evidence and guidelines for prostate biopsies
Summary of evidence | LE |
Literature review including multiple biopsy schemes suggests that a 10 to 12-core scheme is optimal in the majority of initial and repeat biopsy patients, dependent on prostate size. These biopsy schemes should be heavily weighted towards the lateral aspect and the apex of the prostate to maximize peripheral zone sampling. | 3
|
A systematic review and meta-analysis comparing MRI-targeted transrectal biopsy to MRI-targeted transperineal biopsy, analysing 8 studies, showed a higher sensitivity for detection of csPCa when the transperineal approach was used (86% vs. 73%). | 2
|
Current literature, including systematic reviews and meta-analyses, does not show a clear superiority of one image-guided technique (cognitive guidance, US/MR fusion software or direct in-bore guidance) over the other. | 2
|
Recommendations | Strength rating |
At least 8 systematic biopsies are recommended in prostates with a size of about 30 cc and 10 to 12 core biopsies are recommended in larger prostates, with > 12 cores not being significantly more conclusive. | Strong
|
Transperineal biopsies are preferred over transrectal biopsies. | Strong |
Where MRI has shown a suspicious lesion MR-targeted biopsy can be obtained through cognitive guidance, US/MR fusion software or direct in-bore guidance. | Weak
|
5.2.8.2.1 Recommended terminology for reporting prostate biopsies
Recommendation | Strength rating |
Adenocarcinoma, provide type and subtype, and presence or absence of cribriform pattern. | Strong |
5.3.5 Summary of evidence and guidelines for staging of prostate cancer
Summary of evidence | LE |
PSMA PET/CT is more accurate for staging than CT and bone scan for high-risk disease but to date no outcome data exist to inform subsequent management. | 1b
|
Recommendation | Strength rating |
High-risk localised disease/locally advanced disease | |
When using PSMA PET or whole body MRI to increase sensitivity, be aware of the lack of outcome data of subsequent treatment changes. | Strong
|
- 6.1.4.1.1.3.4. Radiopharmaceutical therapy
6.1.6 General guidelines for the treatment of prostate cancer
Recommendations | Strength rating |
Surgical treatment | |
Do not perform nerve-sparing surgery when there is a risk of ipsilateral extracapsular extension (based on cT stage, ISUP grade, magnetic resonance imaging, or with this information combined into a nomogram). | Weak
|
Radiotherapeutic treatment | |
Offer low-dose rate (LDR) brachytherapy monotherapy to patients with good urinary function and low- or intermediate-risk disease with ISUP grade 2 and ≤ 33% of biopsy cores involved. | Strong
|
Offer LDR or high-dose rate (HDR) brachytherapy boost combined with IMRT/VMAT plus IGRT to patients with good urinary function intermediate-risk disease with ISUP G3 and/or PSA 10-20 ng/mL. | Weak
|
Offer LDR or HDR brachytherapy boost combined with IMRT /VMAT plus IGRT to patients with good urinary function and high-risk and/or locally advanced disease. | Weak
|
- 6.2.1.2.1 ADT monotherapy
6.2.1.3 Summary of evidence and guidelines for the treatment of low-risk disease
Summary of evidence | LE |
Systematic biopsies have been scheduled in AS protocols, the number and frequency of biopsies varied, there is no approved standard. | NR
|
Recommendations | Strength rating |
Active surveillance (AS) | |
Selection of patients | |
If MRI is not available, per-protocol confirmatory prostate biopsies should be performed | Weak |
Follow-up of patients |
|
Repeat biopsies should be performed at least once every 3 years for 10 years. | Weak |
In case of PSA progression or change in DRE or MRI findings, do not progress to active treatment without a repeat biopsy. | Strong
|
Active treatment | |
Radiotherapeutic treatment | |
Offer low-dose rate brachytherapy to patients with low-risk PCa and good urinary function. | Strong |
6.2.2.5 Guidelines for the treatment of intermediate-risk disease
Recommendations | Strength rating |
Active surveillance (AS) | |
Offer AS to highly selected patients with ISUP grade group 2 disease (i.e. < 10% pattern 4, PSA <10 ng/mL, ≤ cT2a, low disease extent on imaging and low biopsy extent [defined as ≤ 3 positive cores and cancer involvement ≤ 50% core involvement [CI]/per core]), or another single element of intermediate-risk disease with low disease extent on imaging and low biopsy extent, accepting the potential increased risk of metastatic progression. | Weak
|
Patients with ISUP grade group 3 disease must be excluded from AS protocols. | Strong |
Re-classify patients with low-volume ISUP grade group 2 disease included in AS protocols, if repeat non-MRI-based systematic biopsies performed during monitoring reveal > 3 positive cores or maximum CI > 50%/core of ISUP 2 disease. | Weak
|
Radiotherapeutic treatment | |
Offer low-dose rate brachytherapy to patients with good urinary function and favourable intermediate-risk disease. | Strong
|
Offer low-dose rate brachytherapy boost combined with IMRT/VMAT plus IGRT to patients with good urinary function and unfavourable intermediate-risk disease, in combination with short-term androgen deprivation therapy (ADT) (4–6 months). | Weak
|
Offer high-dose rate brachytherapy boost combined with IMRT/VMAT plus IGRT to patients with good urinary function and unfavourable intermediate-risk disease, in combination with short-term ADT (4–6 months). | Weak
|
In patients not willing to undergo ADT, use a total dose of IMRT/VMAT plus IGRT (76–78 Gy) or moderate hypofractionation (60 Gy/20 fx in 4 weeks or 70 Gy/28 fx in 6 weeks) or a combination with LDR or HDR brachytherapy boost. | Weak
|
6.2.3.4 Guidelines for radical treatment of high-risk localised disease
Recommendation | Strength rating |
Radiotherapeutic treatment | |
In patients with high-risk localised disease and good urinary function, use IMRT/VMAT plus IGRT with brachytherapy boost (either high-dose rate or low-dose rate), in combination with long-term ADT (2 to 3 years). | Weak
|
6.2.4.5 Guidelines for radical treatment of locally-advanced disease
Recommendation | Strength rating |
Radiotherapeutic treatment |
|
Offer patients with locally advanced disease and good urinary function, IMRT/VMAT plus IGRT with brachytherapy boost (either high-dose rate or low-dose rate), in combination with long-term ADT. | Weak
|
Prescribe 2 years of abiraterone when offering IMRT/VMAT plus IGRT to the prostate plus pelvis (for cN1) in combination with long-term ADT, for M0 patients with cN1 or ≥ 2 high-risk factors (cT3–4, Gleason ≥ 8 or PSA ≥ 40 ng/mL). | Strong
|
6.3.4.4 Summary of evidence and guidelines for imaging in patients with biochemical recurrence
Summary of evidence | LE |
After RP there is no specific PSA threshold defining recurrence. | NR |
6.4.9 Guidelines for the first-line treatment of metastatic disease
Recommendations | Strength rating |
Offer luteinising hormone-releasing hormone (LHRH) antagonists or orchiectomy before starting ADT, especially to patients with impending clinical complications like spinal cord compression or bladder outlet obstruction. | Strong
|
Offer early systemic treatment to M1 patients asymptomatic from their tumour. | Strong |
6.5.15 Guidelines for systematic treatments of castrate-resistant disease
Recommendation | Strength rating |
Novel agents | |
Offer 177Lu-PSMA-617 to pre-treated mCRPC patients with one or more metastatic lesions, highly expressing PSMA (exceeding the uptake in the liver) on the diagnostic radiolabelled PSMA PET/CT scan. | Strong
|