Biochemical Recurrence: Difference between revisions

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=== Definition ===

* '''1996 ASTRO (American Society for Therapeutic Radiology and Oncology) definition: 3 consecutive PSA increases measured 6 months apart and backdating the time of cancer progression to halfway between the PSA nadir and the first rising PSA level'''

* '''<span style="color:#ff0000">1996 ASTRO (American Society for Therapeutic Radiology and Oncology) definition: 3 consecutive PSA increases measured 6 months apart and backdating the time of cancer progression to halfway between the PSA nadir and the first rising PSA level</span>'''

* '''2005 Phoenix definition: PSA nadir + 2 ng/mL; failure is not backdated'''. Thus the time to recurrence is further prolonged after the PSA level begins to rise, and often it takes a considerably longer time for the PSA level to increase by 2 ng/mL

* '''<span style="color:#ff0000">2005 Phoenix definition: PSA nadir + 2 ng/mL; failure is not backdated</span>'''. Thus the time to recurrence is further prolonged after the PSA level begins to rise, and often it takes a considerably longer time for the PSA level to increase by 2 ng/mL

** '''The Phoenix definition of definition of failure is associated with fewer false positives for failure than the ASTRO definition'''

* '''Given the differences in defining failure, it is not possible to make fair comparisons between radical prostatectomy and radiotherapy by use of these outcome measurements; other measurements such as metastasis-free survival or cancer-specific survival are more appropriate comparisons of treatment failure'''

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* '''PSA nadir + 1.2 ng/mL has been described as the most effective at predicting for clinical failure and has been proposed as the definition for biochemical failure after HIFU for prostate cancer.'''

* Salvage radiotherapy and salvage prostatectomy have been described as treatments for HIFU failure

== EMBARK Trial ==

* Population: 1068 patients with high-risk biochemical recurrence (defined as a PSA doubling time of ≤9 months and a PSA level of ≥2 ng per milliliter above nadir after radiation therapy or ≥1 ng per milliliter after radical prostatectomy)

* Randomized to enzalutamide + leuprolide vs. enzalutamide only vs. leuprolide only

* Primary end point: metastasis-free survival in the combination group as compared with the leuprolide-alone group

* Results:

** 5-year metastasis-free survival: absolute risk reduction: 16% (87% combination group vs. 71% leuprolide-alone group, significant); NNT: 6

** 5-year overall survival: absolute risk reduction: 5% (92% combination group vs. 87% leuprolide-alone group, not significant)

**Enzalutamide monotherapy better than leuprolide monotherapy for progression-free survival

***First evidence that second-generation androgen deprivation therapy monotherapy better than first-generation monotherapy

* [https://pubmed.ncbi.nlm.nih.gov/37851874/ Freedland, Stephen J., et al.] "Improved outcomes with enzalutamide in biochemically recurrent prostate cancer." ''New England Journal of Medicine'' 389.16 (2023): 1453-1465.

== UrologySchool.com Summary ==

@@ Line 195: / Line 195: @@
 === Definition ===
-* '''1996 ASTRO (American Society for Therapeutic Radiology and Oncology) definition: 3 consecutive PSA increases measured 6 months apart and backdating the time of cancer progression to halfway between the PSA nadir and the first rising PSA level'''
+* '''<span style="color:#ff0000">1996 ASTRO (American Society for Therapeutic Radiology and Oncology) definition: 3 consecutive PSA increases measured 6 months apart and backdating the time of cancer progression to halfway between the PSA nadir and the first rising PSA level</span>'''
-* '''2005 Phoenix definition: PSA nadir + 2 ng/mL; failure is not backdated'''. Thus the time to recurrence is further prolonged after the PSA level begins to rise, and often it takes a considerably longer time for the PSA level to increase by 2 ng/mL
+* '''<span style="color:#ff0000">2005 Phoenix definition: PSA nadir + 2 ng/mL; failure is not backdated</span>'''. Thus the time to recurrence is further prolonged after the PSA level begins to rise, and often it takes a considerably longer time for the PSA level to increase by 2 ng/mL
 ** '''The Phoenix definition of definition of failure is associated with fewer false positives for failure than the ASTRO definition'''
 * '''Given the differences in defining failure, it is not possible to make fair comparisons between radical prostatectomy and radiotherapy by use of these outcome measurements; other measurements such as metastasis-free survival or cancer-specific survival are more appropriate comparisons of treatment failure'''
@@ Line 416: / Line 416: @@
 * '''PSA nadir + 1.2 ng/mL has been described as the most effective at predicting for clinical failure and has been proposed as the definition for biochemical failure after HIFU for prostate cancer.'''
 * Salvage radiotherapy and salvage prostatectomy have been described as treatments for HIFU failure
+== EMBARK Trial ==
+* Population: 1068 patients with high-risk biochemical recurrence (defined as a PSA doubling time of ≤9 months and a PSA level of ≥2 ng per milliliter above nadir after radiation therapy or ≥1 ng per milliliter after radical prostatectomy)
+* Randomized to enzalutamide + leuprolide vs. enzalutamide only vs. leuprolide only
+* Primary end point: metastasis-free survival in the combination group as compared with the leuprolide-alone group
+* Results:
+** 5-year metastasis-free survival: absolute risk reduction: 16% (87% combination group vs. 71% leuprolide-alone group, significant); NNT: 6
+** 5-year overall survival: absolute risk reduction: 5% (92% combination group vs. 87% leuprolide-alone group, not significant)
+**Enzalutamide monotherapy better than leuprolide monotherapy for progression-free survival
+***First evidence that second-generation androgen deprivation therapy monotherapy better than first-generation monotherapy
+* [https://pubmed.ncbi.nlm.nih.gov/37851874/ Freedland, Stephen J., et al.] "Improved outcomes with enzalutamide in biochemically recurrent prostate cancer." ''New England Journal of Medicine'' 389.16 (2023): 1453-1465.
 == UrologySchool.com Summary ==