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Gutman SI, Oliansky DM, Belinson S, et al. PCA3 Testing in the Diagnosis and Management of Prostate Cancer: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 98 [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. (Future Research Needs Papers, No. 24.)
PCA3 Testing in the Diagnosis and Management of Prostate Cancer: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 98 [Internet].
Show detailsKey Question 1 and 2: In patients with elevated PSA and/or abnormal DRE who are candidates for biopsy or repeat biopsy what is the comparative effectiveness of PCA3 testing as a replacement for or addition to standard tests?
Table D.1Literature relevant to Key Questions 1 and 2
| Broad Research Needs | Specific Research Needs | Comments from Stakeholders | Primary Studies | Abstracts (published since CER) | Ongoing Clinical Trials |
|---|---|---|---|---|---|
| Diagnostic accuracy of PCA3 | 1. Lack of information on the comparative performance of PCA3 and currently used biomarkers to detect prostate cancer; lack of “matched studies” on comparators 2. Lack of a definition of “clinically significant improvement” in diagnostic accuracy. 3. Potential for comparisons of PCA3 with tPSA to be affected by inadequate clinical characterization of populations studied 4. Lack of information on how demographics impact PCA3 test | Defining diagnostic accuracy is critical to test use; matched studies are needed Consider reaching out to researchers to better synthesize what information is now available Having a target for accuracy is important – a question to answer is how accurate is accurate enough Biopsy is not a perfect gold standard; consider use in context of imaging. Biopsy is not perfect; consider using prostatectomy outcomes to better understand what kinds of tumors are being detected | From CER: Adam 2011 Ankerst 2008 Aubin 2010 de la Taille 2011 Deras 2008 FDA 2012 Haese 2008 Hessels 2010 Mearini 2009 Nyberg 2010 Ochiai 2011 Ouyang 2009 Perdona 2011 Rigau M 2010 Roobol 2010 Schilling 2010 Wang 2009 Updated Literature Search Auprich 2011 Bollito 2012 Ferro 2012 Goode 2012 Pepe 2012 Wu 2012 | Urinary PCA3 as a predictor for prostate cancer in a cohort of 1928 men undergoing initial prostate biopsy, Chevli et al., American Urological Association, May 21, 2012 PROGENSA PCA3 pivotal U.S. clinical study confirms utility for predicting repeat biopsy outcome. Ward et al., American Urological Association, May 21, 2012 The NCI Early Detection Research Network (EDRN) urinary PCA3 validation trial, Wei et al., American Urological Association, May 23, 2012 PCA3 test as an adjunct in diagnosis of prostate cancer, Yutkin et al., American Urological Association, May 23, 2012 | NCT01177426, Prostate Cancer Antigen 3 (PCA-3) Gene Project – recruiting NCT01441687, Expressed Prostatic Secretion and Post Massage Urine Biomarkers in Predicting Biopsy Results in Patients Undergoing Prostate Biopsy -- recruiting |
| Use of PCA3 in Biopsy Decisionmaking | 5. Lack of information on the impact of PCA3 on short term outcomes such as biopsy decisionmaking | Might adjust analytical framework to emphasize desired outcome; decreased biopsies and less overtreatment Consider modeling using what is known about cancer detection to determine the impact of avoiding biopsies Consider how this might relate to current use of imaging technologies | None identified | The appropriateness of active surveillance and the impact of prostate cancer gene 3 (PCA3) in low risk prostate cancer: an analysis of expert opinion, Speakman et al. Urology, 2011 79(3):S320 | None identified |
| Effect of PCA3 on long-term health outcomes | 6. Uncertainty of impact of PCA3 on long-term health outcomes | Needed but how practical; morbidity is already low, PCA3 might have a hard time proving its merits Evaluation of testing should be performed with attention to what is known or not known about value of PSA screening itself and the fact this matter may have not been settled | None identified | None identified | None identified |
Key Question 3: In patients with positive prostate biopsies what is the comparative effectiveness of PCA3 testing as a replacement for or addition to standard tests in treatment decisionmaking (active surveillance versus more aggressive therapy)?
Table D.2Literature relevant to Key Question 3
| Research Need | CER Findings | Stakeholders | Primary Studies | Abstracts (published since CER) | Ongoing Clinical Trials |
|---|---|---|---|---|---|
| Diagnostic accuracy of PCA3 | 7. Lack of clear endpoint to establish performance; when PCA3 disagrees with other inclusion criteria; how do you know which is right? | No comments | From CER: Liss 2011 Nakanishi 2008 Ploussard 2011 Vlaeminck-Guillem 2011 Whitman 2008 Updated Lit Search Durand 2012 Van Poppel 2011 | Longitudinal followup of prostate specific antigen (PSA) and prostate cancer antigen-3 (PCA3 in men with stable disease on active surveillance, Dangle et al., American Urological Association, May 22, 2012 | None identified |
| Use of PCA3 in Treatment Decisionmaking | 8. Lack of studies on how PCA3 actually helps in treatment decisionmaking? | Possible role as a prognostic marker and in making refinements in therapy beyond active surveillance and aggressive therapy | None identified | None identified | None identified |
| Effect of PCA3 on Long-term Health Outcomes | 9. Lack of information on the impact of PCA3 on long-term health outcomes | No comments | None Identified | None identified | None identified |
References for Primary Studies
- 1.
- Adam A, Engelbrecht MJ, Bornman MS, et al. The role of the PCA3 assay in predicting prostate biopsy outcome in a South African setting. BJU Int. 2011 Apr 20 [PubMed: 21507188]
- 2.
- Ankerst DP, Groskopf J, Day JR, et al. Predicting prostate cancer risk through incorporation of prostate cancer gene 3. J Urol. 2008 Oct;180(4):1303–8. discussion 08. [PubMed: 18707724]
- 3.
- Aubin SM, Reid J, Sarno MJ, et al. PCA3 molecular urine test for predicting repeat prostate biopsy outcome in populations at risk: validation in the placebo arm of the dutasteride REDUCE trial. J Urol. 2010 Nov;184(5):1947–52. [PubMed: 20850153]
- 4.
- Auprich M, Haese A, Walz J, et al. External validation of urinary PCA3-based nomograms to individually predict prostate biopsy outcome. Eur Urol. 2010;58(5):727–32. [PubMed: 20619529]
- 5.
- Bollito E, De Luca S, Cicilano M, et al. Prostate cancer gene 3 urine assay cutoff in diagnosis of prostate cancer: A validation study on an Italian patient population undergoing first and repeat biopsy. Anal Quant Cytol Histol. 2012 Apr;34(2):96–104. [PubMed: 22611765]
- 6.
- de la Taille A, Irani J, Graefen M, et al. Clinical evaluation of the PCA3 assay in guiding initial biopsy decisions. J Urol. 2011 Jun;185(6):2119–25. [PubMed: 21496856]
- 7.
- Deras IL, Aubin SM, Blase A, et al. PCA3: a molecular urine assay for predicting prostate biopsy outcome. J Urol. 2008 Apr;179(4):1587–92. [PubMed: 18295257]
- 8.
- Durand X, Xylinas E, Radulescu C, et al. The value of urinary prostate cancer gene 3 (PCA3) scores in predicting pathological features at radical prostatectomy. BJU Int. 2012;110(1):43–9. [PubMed: 22221521]
- 9.
- FDA Summary of Safety and Effectiveness – Progensa PCA3. www
.accessdata.fda.gov /cdrh_docs/pdf10/P100033b.pdf. - 10.
- Ferro M, Bruzzese D, Perdona S, et al. Predicting prostate biopsy outcome: prostate health index (phi) and prostate cancer antigen 3 (PCA3) are useful biomarkers. Int J Clin Chem. [Clinica chimica acta]. 2012;413(15–16):1274–8. [PubMed: 22542564]
- 11.
- Goode RR, Marshall SJ, Duff M, et al. Use of PCA3 in detecting prostate cancer in initial and repeat prostate biopsy patients. Prostate. 2012 [PubMed: 22585386]
- 12.
- Haese A, de la Taille A, van Poppel H, et al. Clinical utility of the PCA3 urine assay in European men scheduled for repeat biopsy. Eur Urol. 2008 Nov;54(5):1081–8. [PubMed: 18602209]
- 13.
- Hessels D, van Gils MP, van Hooij O, et al. Predictive value of PCA3 in urinary sediments in determining clinico-pathological characteristics of prostate cancer. Prostate. 2010 Jan 1;70(1):10–6. [PubMed: 19708043]
- 14.
- Liss MA, Santos R, Osann K, et al. PCA3 molecular urine assay for prostate cancer: association with pathologic features and impact of collection protocols. World J Urol. 2011 Oct;29(5):683–8. [PMC free article: PMC3189407] [PubMed: 21152924]
- 15.
- Mearini E, Antognelli C, Del Buono C, et al. The combination of urine DD3(PCA3) mRNA and PSA mRNA as molecular markers of prostate cancer. Biomarkers. 2009 Jun;14(4):235–43. [PubMed: 19489685]
- 16.
- Nakanishi H, Groskopf J, Fritsche HA, et al. PCA3 molecular urine assay correlates with prostate cancer tumor volume: implication in selecting candidates for active surveillance. J Urol. 2008 May;179(5):1804–9. discussion 09–10. [PubMed: 18353398]
- 17.
- Nyberg M, Ulmert D, Lindgren A, et al. PCA3 as a diagnostic marker for prostate cancer: a validation study on a Swedish patient population. Scand J Urol Nephrol. 2010 Dec;44(6):378–83. [PubMed: 20961267]
- 18.
- Ochiai A, Okihara K, Kamoi K, et al. Prostate cancer gene 3 urine assay for prostate cancer in Japanese men undergoing prostate biopsy. Int J Urol. 2011 Mar;18(3):200–5. [PubMed: 21332814]
- 19.
- Ouyang B, Bracken B, Burke B, et al. A duplex quantitative polymerase chain reaction assay based on quantification of alpha-methylacyl-CoA racemase transcripts and prostate cancer antigen 3 in urine sediments improved diagnostic accuracy for prostate cancer. J Urol. 2009 Jun;181(6):2508–13. discussion 13–4. [PMC free article: PMC4372725] [PubMed: 19371911]
- 20.
- Pepe P, Fraggetta F, Galia A, Aragona F. Is PCA3 score useful in preoperative staging of a single microfocus of prostate cancer diagnosed at saturation biopsy? Urol Int. 2012 Aug 3 [Epub ahead of print] [PubMed: 22868485]
- 21.
- Perdona S, Cavadas V, Di Lorenzo G, et al. Prostate cancer detection in the “grey area” of prostate-specific antigen below 10 ng/ml: head-to-head comparison of the updated PCPT calculator and Chun’s nomogram, two risk estimators incorporating prostate cancer antigen 3. Eur Urol. 2011 Jan;59(1):81–7. [PubMed: 20947244]
- 22.
- Ploussard G, Durand X, Xylinas E, et al. Prostate cancer antigen 3 score accurately predicts tumour volume and might help in selecting prostate cancer patients for active surveillance. Eur Urol. 2011 Mar;59(3):422–9. [PubMed: 21156337]
- 23.
- Rigau M, Morote J, Mir MC, et al. PSGR and PCA3 as biomarkers for the detection of prostate cancer in urine. Prostate. 2010 Dec 1;70(16):1760–7. [PubMed: 20672322]
- 24.
- Roobol MJ, Schroder FH, van Leeuwen P, et al. Performance of the prostate cancer antigen 3 (PCA3) gene and prostate-specific antigen in prescreened men: exploring the value of PCA3 for a first-line diagnostic test. Eur Urol. 2010 Oct;58(4):475–81. [PubMed: 20637539]
- 25.
- Schilling D, Hennenlotter J, Munz M, et al. Interpretation of the prostate cancer gene 3 in reference to the individual clinical background: implications for daily practice. Urol Int. 2010;85(2):159–65. [PubMed: 20424427]
- 26.
- Vlaeminck-Guillem V, Devonec M, Colombel M, et al. Urinary PCA3 score predicts prostate cancer multifocality. J Urol. 2011 Apr;185(4):1234–9. [PubMed: 21334023]
- 27.
- Van Poppel, Haese, Graefen, et al. The relationship between Proostate Cancer gene 3 (PCA3) and prostate cancer significance. BJU Int. 2011 Aug 26;109:360–366. [PubMed: 21883822]
- 28.
- Wang R, Chinnaiyan AM, Dunn RL, et al. Rational approach to implementation of prostate cancer antigen 3 into clinical care. Cancer. 2009 Sep 1;115(17):3879–86. [PMC free article: PMC2746943] [PubMed: 19517474]
- 29.
- Whitman EJ, Groskopf J, Ali A, et al. PCA3 score before radical prostatectomy predicts extracapsular extension and tumor volume. J Urol. 2008 Nov;180(5):1975–8. discussion 78–9. [PubMed: 18801539]
- 30.
- Wu AK, Reese AC, Cooperberg MR, et al. Utility of PCA3 in patients undergoing repeat biopsy for prostate cancer. Prostate Cancer and Prostatic Dis. 2012;15(1):100–5. [PubMed: 22042252]
- Literature Relevant to PCA3 Research Needs - PCA3 Testing in the Diagnosis and M...Literature Relevant to PCA3 Research Needs - PCA3 Testing in the Diagnosis and Management of Prostate Cancer: Future Research Needs
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