Biochemical Recurrence: A Valuable Endpoint?
Clinically relevant outcomes such as distant metastases and death from prostate cancer do not occur for many years after definitive treatment for localized prostate cancer. In view of the long natural history of prostate cancer, the identification and validation of surrogate endpoints that can be measured earlier and correlate with clinical progression or survival are of great utility in clinical cancer research. With the introduction of prostate-specific antigen (PSA) as a marker in the mid-1980s, PSA has become an important tool for monitoring disease progression following definitve treatment of localized prostate cancer and the concept of “biochemical” recurrence, an event that precedes clinical recurrence by many years, has been developed. Biochemical failure has become widely accepted to evaluate the effectiveness of definitive local therapies and is used for both research and clinical purposes. Biochemical recurrence has been investigated as a prognostic factor and as a potential surrogate endpoint in different stages of disease; however, on the basis of conflicting results from previous studies, a consensus on the ability of biochemical failure to act as a reliable surrogate endpoint for clinical progression and survival has not yet been reached.
KeywordsRadical Prostatectomy Localize Prostate Cancer Biochemical Recurrence Biochemical Failure Androgen Suppression
- American Society for Therapeutic Radiology and Oncology Consensus Panel (1997) Consensus statement: guidelines for PSA following radiation therapy. Int J Radiat Oncol Biol Phys 37:1035–1041Google Scholar
- Collette L, Burzykowski T, Caroll KJ et al (2005) PSA is not a valid surrogate endpoint for overall survival in patients with metastatic prostate cancer. A joint research of the European Organisation for Research and Treatment of Cancer, the Limburgs Universitair Centrum and AstraZeneca Pharmaceuticals. J Clin Oncol 23:6139–6148PubMedCrossRefGoogle Scholar
- Cookson MS, Aus G, Burnett AL et al (2007) Variation in the definition of biochemical recurrence in patients treated for localized prostate cancer: the American Urological Association Prostate Guidelines for Localized Prostate Cancer Update Panel report and recommendations for a standard in the reporting of surgical outcomes. J Urol 177:540–545PubMedCrossRefGoogle Scholar
- D’Amico AV, Chen M-H, de Castro M et al (2012) Surrogate endpoints for prostate cancer-specific mortality after radiotherapy and androgen suppression therapy in men with localised or locally advanced prostate cancer: an analysis of two randomised trials. Lancet Oncol 13:189–195PubMedCrossRefGoogle Scholar
- Grimm P, Billiet I, Bostwick D et al (2012) Comparative analysis of prostate-specific antigen free survival outcomes for patients with low, intermediate and high-risk prostate cancer treatment by radical therapy. Results from the Prostate Cancer Results Study Group. BJU Int 109(Suppl 1):22–29PubMedCrossRefGoogle Scholar
- Johnson JR, Williams G, Pazdur R (2003) Endpoints and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 21:1401–1411Google Scholar
- Lamb DS, Denham JW, Joseph D et al (2011) A comparison of the prognostic value of early PSA test-based variables following external beam radiotherapy, with or without preceding androgen deprivation: analysis of data from the Trog96.01 randomized trial. Int J Radiat Oncol Biol Phys 79:385–391PubMedCrossRefGoogle Scholar
- Roach M III, Hanks G, Thames H Jr et al (2006) Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys 65:965–974PubMedCrossRefGoogle Scholar
- Wiegel T, Bottke D, Steiner U et al (2009) Phase III postoperative adjuvant radiotherapy after radical prostatectomy compared with radical prostatectomy alone in pT3 prostate cancer with postoperative undetectable prostate-specific antigen: ARO 96-02/AUO AP 09/95. J Clin Oncol 27:2924–2930PubMedCrossRefGoogle Scholar
- Zietman AL, Bae K, Slater JD et al (2010) Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: Long-term results from Proton Radiation Oncology Group/American College of Radiology 95-09. J Clin Oncol 28:1106–1111PubMedCentralPubMedCrossRefGoogle Scholar