Provide evidence- and expert-based recommendations for optimal use of imaging in advanced prostate cancer. Due to increases in research and utilization of novel imaging for advanced prostate cancer, this guideline is intended to outline techniques available and provide recommendations on appropriate use of imaging for specified patient subgroups.
Target Patient Population
Men with advanced prostate cancer, including newly diagnosed clinical high-risk disease, suspected or confirmed metastatic disease, recurrent disease, or progressive disease while under treatment
Target Provider Population
Medical oncologists, radiation oncologists, urologists, radiologists, nuclear medicine and molecular imaging
PICO Questions
What is the goal of imaging in advanced prostate cancer?
What imaging techniques are available for imaging advanced prostate cancer?
What are the unmet needs and potential impact of imaging according to different advanced prostate cancer disease states?
ASCO has a rigorous review process for guidelines. After the draft has been approved by the Expert Panel, the guideline is independently reviewed and approved by the Clinical Practice Guideline Oversight Committee (CPGC). Select members of the CPGC are asked to critically review the guideline prior to the next scheduled CPGC meeting. The CPGC members then present the results of their reviews to the full committee, discuss the review with the full committee, and the CPGC votes on whether to approve the guideline (with recusals from members who have relationships with affected companies). Approved ASCO Guidelines are then submitted to the Society’s journal for consideration of publication.
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Description of Public Comment Process
Draft recommendations were released to the public for open comment. Response categories of “Agree as written,” “Agree with suggested modifications,” and “Disagree. See comments” were captured for every proposed recommendation, with 13 submissions received. A total of 100% of the 13 respondents either agreed or agreed with slight modifications to the recommendations, and 0% of the respondents disagreed. Expert Panel members reviewed comments from all sources and determined whether to maintain original draft recommendations, revise with minor language changes, or consider major recommendation revisions. All changes were incorporated prior to CPGC review and approval.
The Protocol specifies the purpose of the guideline product, target patient population, clinical outcomes
of interest, key features of the systematic literature review, and a proposed timeline for completion. ASCO staff,
the Expert Panel Co‐Chairs, and possibly other panel members selected by the Co‐Chairs (the Expert Panel
Steering Committee), will typically draft the protocol for full panel review. A standard protocol worksheet is used for consistency.
Once the Co‐Chairs have approved a first draft of the Protocol, the Protocol will be shared with the full Expert
Panel. At the discretion of the Guidelines Director, the CPGC leadership and/or the CPGC Methodology
Subcommittee may review the Protocol to make suggestions for revision intended to clarify aspects of the plan
for developing the guideline. These suggestions are sent to the Expert Panel Co‐Chairs. Work on the systematic
literature review can proceed upon the sign‐off of the Protocol by the Expert Panel.
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List of Questions
This clinical practice guideline addresses four overarching clinical questions:
What is the goal of imaging in advanced prostate cancer?
What imaging techniques are available for imaging advanced prostate cancer?
What are the unmet needs and potential impact of imaging according to different advanced prostate cancer disease states?
When and what type of imaging is appropriate in each scenario?
The recommendations are framed according to these clinical scenarios:
Newly diagnosed clinically high-risk/very high-risk prostate cancer
Conventional imaging negative
Conventional imaging suspicious/equivocal
Rising PSA after prostatectomy and negative conventional imaging
Initial PSA undetectable with subsequent rise
PSA never nadirs to undetectable
Rising PSA after radiotherapy and negative conventional imaging
Metastatic prostate cancer at initial diagnosis or after treatment, hormone sensitive
Nonmetastatic castration-resistant prostate cancer (CRPC)
Metastatic CRPC
PSA progression
Radiographic progression on conventional imaging
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Description of Study Criteria
Articles were selected for inclusion in the systematic review of the evidence based on the following criteria:
Population: men with advanced prostate cancer
Fully published or recent meeting presentations of English-language systematic reviews with or without meta-analyses, reports of rigorously conducted phase III RCTs that compared two or more imaging modalities, and noncomparative studies that report on the efficacy of a single imaging modality
Reported on a minimum number of patients (> 50)
Articles were excluded from the systematic review if they were (1) meeting abstracts not subsequently published in peer-reviewed journals; (2) editorials, commentaries, letters, news articles, case reports, or narrative reviews; or (3) published in a non-English language.
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Description of Search Strategy
Upon approval of the Protocol, a systematic review of the medical literature is conducted. ASCO staff use
the information entered into the Protocol, including the clinical questions, inclusion/exclusion criteria for
qualified studies, search terms/phrases, and range of study dates, to perform the systematic review. Literature
searches of selected databases, including The Cochrane Library and Medline (via PubMed) are performed. Working with the Expert Panel, ASCO staff complete screening of the abstracts and full text articles to determine
eligibility for inclusion in the systematic review of the evidence.
Unpublished data from meeting abstracts are not generally used as part of normal ASCO guideline development
(“Meeting Data”). However, abstract data from reputable scientific meetings and congresses may be included on
a case‐by‐case basis after review by the CPGC leadership. Expert Panels should present a rationale to support
integration of abstract data into a guideline. The CPGC leadership will consider the following inclusion criteria for
the unpublished scientific meeting data: 1) whether the data were independently peer reviewed in connection
with a reputable scientific meeting or congress; 2) the potential clinical impact of the unpublished data; 3) the
methodological quality and validity of the associated study; 3) the potential harms of not including the data; and
4) the availability of other published data to inform the guideline recommendations.
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Description of Study Selection
Literature search results were reviewed and deemed appropriate for full text review by two ASCO staff reviewers in consultation with the Expert Panel Co-Chairs. Data were extracted by two staff reviewers and subsequently checked for accuracy through an audit of the data by another ASCO staff member. Disagreements were resolved through discussion and consultation with the Co-Chairs if necessary.
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Description of Evidence Analysis Methods
ASCO guideline recommendations are crafted, in part, using the GuideLines Into DEcision Support (GLIDES) methodology. ASCO adopted a five‐step approach to carry out quality appraisal, strength of evidence ratings and strength of recommendations ratings. The ASCO approach was primarily adapted from those developed by the AHRQ,, USPSTF, and GRADE, however with the validation of the GRADE methodology, the sole use of GRADE is being evaluated by the Clinical Practice Guidelines Committee.
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Description of Evidence Grading
High: High confidence that the available evidence reflects the true magnitude and direction of the net effect (i.e., balance of benefits v harms) and that further research is very unlikely to change either the magnitude or direction of this net effect.
Intermediate: Moderate confidence that the available evidence reflects the true magnitude and direction of the net effect. Further research is unlikely to alter the direction of the net effect; however, it might alter the magnitude of the net effect.
Low: Low confidence that the available evidence reflects the true magnitude and direction of the net effect. Further research may change either the magnitude and/or direction this net effect.
Insufficient: Evidence is insufficient to discern the true magnitude and direction of the net effect. Further research may better inform the topic. The use of the consensus opinion of experts is reasonable to inform outcomes related to the topic.
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Description of Recommendation Grading
ASCO uses a formal consensus methodology based on the modified Delphi technique in clinically important areas where there is limited evidence or a lack of high‐quality evidence to inform clinical guidance recommendations.
Evidence Based: There was sufficient evidence from published studies to inform a recommendation to guide clinical practice.
Formal Consensus: The available evidence was deemed insufficient to inform a recommendation to guide clinical practice. Therefore, the Expert Panel used a formal consensus process to reach this recommendation, which is considered the best current guidance for practice. The Panel may choose to provide a rating for the strength of the recommendation (i.e., "strong," "moderate," or "weak"). The results of the formal consensus process are summarized in the guideline and reported in the Data Supplement (see the Supporting Documents" field).
Informal Consensus: The available evidence was deemed insufficient to inform a recommendation to guide clinical practice. The recommendation is considered the best current guidance for practice, based on informal consensus of the Expert Panel. The Panel agreed that a formal consensus process was not necessary for reasons described in the literature review and discussion. The Panel may choose to provide a rating for the strength of the recommendation (i.e., "strong," "moderate," or "weak").
No recommendation: There is insufficient evidence, confidence, or agreement to provide a recommendation to guide clinical practice at this time. The Panel deemed the available evidence as insufficient and concluded it was unlikely that a formal consensus process would achieve the level of agreement needed for a recommendation.
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Description of Funding Source
ASCO provides funding for Guideline Development.
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Company/Author Disclosures
ASCO Conflict of Interest Policy complies with the CMSS Code for Interactions with Companies. ASCO requires disclosure by individuals involved in drafting, reviewing, and approving guideline recommendations.