2. Introduction – Prostate Cancer

This guideline is an evidence-based and consensus-based tool to improve the early detection, diagnosis, and treatment of prostate cancer.

Patients and physicians are to be supported by the guideline in the decision-making process for early detection measures. The guideline is intended to help ensure appropriate health care for early detection.

It is also the task of the guideline to offer patients (with suspected or proven prostate cancer) appropriate, scientifically-based, and up-to-date procedures in diagnosis, treatment, and rehabilitation. This applies to localized or locally-advanced disease, as well as the presence of recurrence or distant metastases.

In addition to contributing to appropriate health care, the guideline is also intended to provide the basis for individualized, high-quality therapy. In the medium and long term, this should reduce the morbidity and mortality of patients with prostate cancer and improve their quality of life.

Adverse effetcs of prostate cancer treatment are to be minimized by implementing guideline-based treatment. Short-term and long-term consequences, especially the rate of patients with erectile dysfunction, incontinence, and bowel damage (including proctitis) will be recorded for each primary treatment procedure for prostate cancer. For this purpose, the „expanded prostate cancer index composite“ (EPIC-26) is used to document an internationally comparable functional treatment outcome in patients with prostate cancer.

The guideline (Version 6.2 October 2021) is valid until the next update. Regular modular updates are planned at 3-year intervals.

Comments and suggested changes are welcomed at the following address: 
prostatakarzinom@leitlinienprogramm-onkologie.de.

In the headers of the recommendations and statements, it was noted when they were created or updated, and whether they were modified or newly created. The following categories of labeling are used:

checked = the validity of the recommendation or statement was verified during the update.

modified = changes were made to the content of the recommendation or statement that were formally consented to

new = the recommendation or statement was newly created and formally consented during the update.

To classify the risk of bias of the identified studies, this guideline used the Scottish Intercollegiate Guidelines Network (SIGN) system listed in Table 2 (see here). 

Table 2: SIGN evidence grading scheme

Grade	Description
1++	High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+	Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias
1-	Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2++	High quality systematic reviews of case control or cohort or studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal
2+	Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal
2-	Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal
3	Non-analytic studies, e.g. case reports, case series
4	Expert opinion

The methodology of the German Guideline Program in Oncology provides for an assignment of recommendation grades by the guideline authors within the framework of a formal consensus process. Accordingly, moderated nominal group processes or structured consensus conferences were conducted by the AWMF [AWMF Guidelines Rulebook 2020]. Within these processes, recommendations were formally voted on by the voting mandate holders. The results of the respective votes (consensus strength) are assigned to the recommendations according to the categories in Table 4.

In the guideline, the level of evidence (see 2.2.1) of the underlying studies and, in the case of recommendations, the strength of the recommendation (degree of recommendation) are additionally reported for all evidence-based statements and recommendations. With regard to the strength of the recommendation, this guideline distinguishes between three levels of recommendation (see Table 3), which are also reflected in the specific wording of the recommendations.

 

Table 3: Scheme of recommendation grading

Grade of recommendation	Description	Expression
A	Strong recommendation	shall
B	Recommendation	should
0	Open recommendation	can

 

Table 4: Consensus strength

Consensus Strength	Consensus Percentage
Strong consensus	> 95% of those eligible to vote
Consensus	> 75 – 95% of those eligible to vote
Majority agreement	50 – 75% of those eligible to vote
Dissent	< 50% of those eligible to vote

The German Cancer Aid provided the financial resources through the German Guideline Program in Oncology (GGPO). These funds were used for personnel costs, office materials, literature procurement, and the consensus conferences (room hire, technical facilities, catering, chairpersons' fees, participants' travel expenses). The guideline was prepared with editorial independence from the funding organization. All members provided a written declaration of any conflicts of interest during the guideline process. The disclosed conflicts of interest are listed in the guideline report for this guideline (http://leitlinienprogramm-onkologie.de/Leitlinien.7.0.html).

Participants who did not provide a declaration were excluded from the consensus processes. Statements of interests were to be made as part of a self-declaration. In 2021, the declarations were assessed in an online portal by AWMF and ÄZQ staff.

• Low interests: industry-funded lectures + industry consulting for drugs for which patent protection no longer exists: no consequence for the voting processes
• Moderate interests: Advisory/scientific advisory board or study responsibility funded by the industry for systemic therapy with patent protection and for medical devices and patents/ownership interest: Abstention from the voting processes
• High conflicts of interest: earnings predominantly from the industry

The issue of conflicts of interest was discussed in the guideline group and also addressed during the consensus conferences. Subject matter experts were encouraged to abstain from votes where they had a financial conflict of interest. Abstentions were documented in the transcript. The disclosed relationships and facts are presented in the guideline report in each case.

The risk of undue influence by interests was reduced by the fact that the search, selection, and evaluation of the literature was performed by methodologists (from the ÄZQ) without significant relationships to the industry or interest groups. Formal consensus building and interdisciplinary preparation, as well as the opportunity for public review, provided additional elements that may reduce the risk of bias.

At this point, we would like to thank all collaborators for their exclusively voluntary work on the project.