List of clinical questions
Guidelines developed in partnership with
This resource has been developed, reviewed or revised more than five years ago. It may no longer reflect current evidence or best practice.
Published: 2015
National Health and Medical Research Council 
These guidelines (recommendations) in the web-version of this guideline were approved by the Chief Executive Officer of the National Health and Medical Research Council (NHMRC) on 2 November 2015 under section 14A of the National Health and Medical Research Council Act 1992 In approving the guidelines (recommendations), NHMRC considers that they meet the NHMRC standard for clinical practice guidelines. This approval is valid for a period of five years. NHMRC is satisfied that the guidelines (recommendations) are systematically derived, based on the identification and synthesis of the best available scientific evidence, and developed for health professionals practising in an Australian health care setting.
This publication reflects the views of the authors and not necessarily the views of the Australian Government.
Appendix 3 List of clinical questions
| Question No. | Clinical Questions | Corresponding PICO Question(s) |
|---|---|---|
| Risk | ||
| 1 | What risk factors can identify Australian men who are at high risk of prostate cancer or death from prostate cancer?
Suggested risk factors include: Family history |
1: For Australian men, has a family history of prostate cancer been shown to be reliably associated with a 2.0-fold or greater increase in risk of occurrence of or death from prostate cancer when compared to men who do not have a family history of prostate cancer? |
| Testing | ||
| 2 | What methods of decision support for men about PSA testing increase men’s capacity to make an informed decision for or against testing? | 2: In men without evidence of prostate cancer does a decision support intervention or decision aid compared with usual care improve knowledge, decisional satisfaction, decision-related distress and decisional uncertainty about PSA testing for early detection of prostate cancer? |
| 3 | In men without a prior history of prostate cancer or symptoms that might indicate prostate cancer, what should be the PSA testing strategies (age to start, level at which to declare a test abnormal and frequency of subsequent testing if the PSA level is normal) for men at average risk of prostate cancer and how should they be modified, if at all, for men at high risk of prostate cancer? | 3.1: For men without a prostate cancer diagnosis or symptoms that might indicate prostate cancer what PSA testing strategies (with or without DRE), compared with no PSA testing or other PSA testing strategies, reduce prostate cancer specific mortality or the incidence of metastases at diagnosis and offer the best balance of benefits to harms of testing?
3.2: For men without a prostate cancer diagnosis or symptoms that might indicate prostate cancer what PSA testing strategies with or without DRE perform best in detecting any prostate cancer or high grade prostate cancer diagnosed in biopsy tissue? 3.3: For men without a prostate cancer diagnosis or symptoms that might indicate prostate cancer does a PSA level measured at a particular age in men assist with determining the recommended interval to the next PSA test? |
| 4 | How best can DRE be used, if at all, in association with PSA testing? | 4: For men without a prostate cancer diagnosis or symptoms that might indicate prostate cancer what is the incremental value of performing a digital rectal examination (DRE) in addition to PSA testing in detecting any prostate cancer? |
| 5 | What age or health status criteria should be used to identify men who would be unlikely to live long enough to benefit from PSA testing and who, in consequence, would not be offered PSA testing? | 5: For men without a prostate cancer diagnosis or symptoms that might indicate prostate cancer, how many years after the start of PSA testing is the benefit of PSA testing apparent? |
| 6 | In men without a prior history of prostate cancer or symptoms that might indicate prostate cancer, what tests for prostate cancer should be offered in addition to a PSA test?
Candidate tests include:
free-to total PSA %
PSA velocity
Prostate health index
|
Free-to-total PSA % 6.1a: For asymptomatic men with an initial total PSA below or equal to 3.0 ng/mL does measuring free-to-total PSA percentage improve the detection of prostate cancer or high-grade prostate cancer without resulting in unacceptable numbers of unnecessary biopsies, when compared with a single total PSA result above 3.0 ng/mL? 6.1b: For asymptomatic men with an initial total PSA above 3.0 ng/mL, does measuring free-to-total PSA percentage improve relative specificity without compromising prostate cancer or high-grade prostate cancer detection, when compared with a single total PSA result above 3.0 ng/mL?
|
| Prostate biopsy and multiparametric MRI | ||
| 7 | What constitutes an adequate prostate biopsy? | 7: For men undergoing an initial prostate biopsy how many biopsy cores, which pattern of biopsy sampling sites and which approach constitute an adequate prostate biopsy? |
| 8 | If prostate cancer is not found in an adequate biopsy what if any additional steps should be taken and what recommendations should be made regarding the strategy for subsequent PSA testing? | 8.1: In men who have been referred with suspected prostate cancer, what are the prognostic factors that determine the need for further investigation following a prior negative biopsy?
8.2: In men with suspected prostate cancer whose initial TRUS biopsy is negative, what should be the next investigation(s)? |
| Active surveillance | ||
| 9 | What should be the criteria for choosing active surveillance in preference to definitive treatment to offer as primary management to men who have a positive prostate biopsy? | 9: For men with biopsy-diagnosed prostate cancer, for which patients (based on diagnostic, clinical and other criteria) does active surveillance achieve equivalent or better outcomes in terms of length and quality of life than definitive treatment? |
| 10 | What is the best monitoring protocol for active surveillance and what should be the criteria for intervention? | 10: For men with biopsy-diagnosed prostate cancer following an active surveillance protocol, which combination of monitoring tests, testing frequency and clinical or other criteria for intervention achieve the best outcomes in terms of length and quality of life? |
| Watchful waiting | ||
| 11 | What should be the criteria for choosing watchful waiting in preference to definitive treatment to offer as primary management to men who have a positive prostate biopsy? | 11: For men with biopsy-diagnosed prostate cancer, for which patients (based on diagnostic, clinical and other criteria) does watchful waiting achieve equivalent or better outcomes in terms of length and quality of life than definitive treatment? |
| 10 | What is the best monitoring protocol for active surveillance and what should be the criteria for intervention? | 10: For men with biopsy-diagnosed prostate cancer following an active surveillance protocol, which combination of monitoring tests, testing frequency and clinical or other criteria for intervention achieve the best outcomes in terms of length and quality of life? |
| 12 | What is the best monitoring protocol for watchful waiting and what should be the criteria for intervention? | 12: For men with biopsy-diagnosed prostate cancer following a watchful waiting protocol, which combination of monitoring tests, testing frequency and clinical or other criteria for intervention achieve the best outcomes in terms of length and quality of life? |