METHODS OF DETERMINING A PATIENT'S PROGNOSIS FOR RECURRENCE OF PROSTATE CANCER AND/OR DETERMINING A COURSE OF TREATMENT FOR PROSTATE CANCER FOLLOWING A RADICAL PROSTATECTOMY

• US 20160258959A1
• Filed: 12/09/2015
• Published: 09/08/2016
• Est. Priority Date: 06/09/2011
• Status: Active Application

• Current Assignee: Quanterix Corporation
• Original Assignee: Quanterix Corporation
• Inventors: Okrongly, David, Wilson, David, Duffy, David C., Hanlon, David
• Application Number:
  US14/963,421
• Publication Number:
  US 20160258959A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: C07K 16/3069 Reproductive system, e.g. ovaria, uterus, testes, prostate
• CPC Class Codes: G01N 2333/96455 Kallikrein (3.4.21.34; 3.4.21.35)
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 2800/54 Determining the risk of relapse
• CPC Class Codes: G01N 2800/56 Staging of a disease; Further complications associated with the disease
• CPC Class Codes: G01N 33/57434 of prostate

Abstract

The present invention generally relates, in some embodiments, to methods of determining a patient'"'"'s prognosis for recurrence of prostate cancer and/or determining a course of treatment for prostate cancer following a radical prostatectomy.

Claims

1. A method of determining a patient'"'"'s prognosis for recurrence of prostate cancer and/or determining a course of treatment for prostate cancer, following a radical prostatectomy, comprising:

performing an assay on a sample obtained from the patient following the radical prostatectomy to determine a measure of the concentration of prostate specific antigen (PSA) in the sample, wherein the concentration of PSA in the sample is less than about 50 pg/mL; and

determining the patient'"'"'s prognosis for recurrence of prostate cancer and/or determining a course of treatment for prostate cancer following the radical prostatectomy based at least in part on the measured concentration of PSA in the sample, wherein determining the patient'"'"'s prognosis for recurrence of prostate cancer and/or determining a course of treatment does not require measurement of a change in concentration of PSA measured in multiple patient samples as a function of time elapsed after the radical prostatectomy.

13. The method of claim 1, wherein the at least one sample is a bodily fluid.

14. The method of claim 13, wherein the bodily fluid is blood or a blood component.

15. The method of claim 13, wherein the blood component is plasma or serum.

16. The method of claim 1, wherein 2, samples are obtained from the patient.

17. The method of claim 1, wherein the limit of quantification of the assay is less than about 9 pg/mL.

19. The method of claim 1, wherein measured concentration of PSA in the sample is less than about 40 pg/mL.

28. The method of claim 1, wherein the measured concentration of PSA is the patient'"'"'s nadir PSA.

29. The method of claim 1, wherein the assay comprises:

spatially segregating at least a portion of the PSA molecules into a plurality of separate locations;

addressing at least a portion of the plurality of locations subjected to the spatially segregating step and determining the number of said locations containing a PSA molecules; and

determining a measure of the concentration of PSA in the sample based at least in part on the number of locations determined to contain a PSA molecules.

30. The method of claim 29, further comprising exposing the plurality of PSA molecules to a plurality of binding ligands such that at least some of the PSA molecules associate with a single binding ligand and a statistically significant fraction of the PSA molecules do not associate with any binding ligand;

31. The method of claim 1, wherein the assay comprises:

immobilizing PSA molecules with respect to a plurality of capture objects such that at least some of the capture objects associate with at least one PSA molecule and a statistically significant fraction of the capture objects do not associate with any PSA molecules;

spatially segregating at least a portion of the capture objects subjected to the immobilizing step into a plurality of separate locations;

addressing at least a portion of the plurality of locations subjected to the spatially segregating step and determining the number of said locations containing a PSA molecule; and

determining a measure of the concentration of PSA in the sample based at least in part on the number of locations determined to contain a PSA molecule.

32. The method of claim 1, wherein the assay comprises:

exposing a plurality of capture objects that each include a binding surface having affinity for PSA, to a solution containing or suspected of containing PSA;

immobilizing PSA molecules with respect to the plurality of capture objects such that at least some of the capture objects associate with at least one PSA molecule and a statistically significant fraction of the capture objects do not associate with any PSA molecules;

spatially segregating at least a portion of the capture objects subjected to the immobilizing step into a plurality of separate locations;

addressing at least a portion of the plurality of locations subjected to the spatially segregating step and determining the number of said locations containing a PSA molecule; and

determining a measure of the concentration of PSA in the sample based at least in part on the number of locations determined to contain a PSA molecule.

2-3. -3. (canceled)

4. A method of determining a patient'"'"'s prognosis for recurrence of prostate cancer, and/or determining a course of treatment for prostate cancer following a radical prostatectomy, comprising:

performing an assay on a sample obtained from the patient following the radical prostatectomy to determine a measure of the concentration of prostate specific antigen (PSA) in the sample, wherein the sample is obtained from the patient within 6 months following the radical prostatectomy; and

determining the patient'"'"'s prognosis for recurrence of prostate cancer and/or determining a course of treatment for prostate cancer following a radical prostatectomy based at least in part on the concentration of PSA measured in the sample, wherein determining the patient'"'"'s prognosis for recurrence of prostate cancer and/or determining a course of treatment does not require measurement of a change in concentration of PSA measured in multiple patient samples as a function of time elapsed after the radical prostatectomy.

21. The method of claim 4, wherein measured concentration of PSA in the sample is less than about 100 pg/mL.

22. The method of claim 4, wherein the sample is obtained from the patient within 5 months following the radical prostatectomy.

5-6. -6. (canceled)

7. A method of determining a patient'"'"'s prognosis for recurrence of prostate cancer, and/or determining a course of treatment for prostate cancer following a radical prostatectomy, comprising:

performing an assay on at least one sample obtained from the patient following the radical prostatectomy to determine a measure of the concentration of prostate specific antigen (PSA) in the at least one sample; and

determining the patient'"'"'s prognosis for recurrence of prostate cancer and/or determining a course of treatment for prostate cancer following a radical prostatectomy based at least in part on the concentration of PSA measured in the at least one sample, wherein a measured concentration of PSA in the at least one sample greater than a threshold limit of no greater than about 10 pg/mL indicates a significant likelihood that the patient'"'"'s prostate cancer will reoccur within 5 years.

23. The method of claim 7, wherein the threshold limit is no greater than about 9 pg/mL.

25. The method of claim 7, wherein the at least one following a radical prostatectomy.

26. The method of claim 7, wherein a measured concentration of PSA greater than a threshold limit of no greater than about 10 pg/mL indicates that the patient'"'"'s chance of recurrence of prostate cancer is at greater than about 50% within 5 years.

8-12. -12. (canceled)

18. (canceled)

20. The method of claim, wherein the sample is obtained from the patient at or less than about 2 years following the radical prostatectomy.

24. (canceled)

27. (canceled)

33-49. -49. (canceled)