Table 5 KQ2 eligibility criteria (benefits and harms of additional information following an elevated PSA test)

Population

Individuals with an elevated* PSA test

*definition of elevated to be determined by the included study

Secondary analyses for decision-making:

• PSA thresholds

• Age: <55 years, 55–69 years, ≥70 years

• Race and/or ethnicity

• Obesity, as defined by the study authors

• Family history

Individuals <18 years. Individuals with a history of prostate cancer. Individuals who have had a previous PSA screen are not excluded.

Individuals specifically selected for the presence of another condition or risk factor (e.g., other types of cancer, individuals working with chemicals known to be carcinogenic, individuals with known genetic risk)

Interventions

Additional testing (e.g., risk stratification, MRI)

Tests used alone, sequentially or in combination to determine the need for biopsy, including but not limited to clinical variables (e.g., age, family history of prostate cancer, a previous biopsy), ratio of free to total PSA, blood biomarkers (PSA, MIC1, etc.) or biomarker panels (4K panel, STHLM3 panel), urine biomarkers, genetic markers, DRE, prostate volume, imaging markers/techniques (e.g., mp-MRI), nomograms combining one or more of the above variables or tests.

Any post-biopsy intervention (e.g., MRI that stratifies risk of an already diagnosed cancer)

Comparator

No additional testing (PSA-based screening only (including single threshold PSA test, age-specific thresholds, variable screening intervals))

Usual care

N/A

Outcomes

Potential benefits

1. Reduced prostate cancer mortality

2. Reduced all-cause mortality

3. Reduced incidence of metastatic cancer

Potential harms

4. False positives

5. Overdiagnosis^a

6. Complications due to biopsy

7. Incontinence (urinary or bowel)

8. Erectile dysfunction

Either benefit or harm

9. Quality of life or functioning (overall and disease-specific*)

10. Psychological effects

As defined/reported by the study authors.

*Scales with acceptable measurement properties (e.g., validity, reliability) for use in prostate cancer

N/A

Timing of outcome assessment

Any timing

N/A

Delivery setting

Majority recruited from primary care settings

Settings not generalizable to primary care

Study design

RCTs (including cluster RCTs), observational studies with consecutively enrolled populations

Case reports, case series, systematic reviews^b, narrative reviews, editorials, commentaries, letters, conference proceedings, government reports.

Language

English or French

N/A

Dates of publication

All dates

N/A