Compositions and methods for identification, assessment and treatment of cancer patient

A method for use in classifying a prostate cancer biological sample or patient as (i) strong responder (SR), (ii) responder (R), (iii) weak responder (WR) or (iv) non-responder (NR) to radiation treatment, wherein the classification provides guidance for dose escalation, de-escalation or alternate therapy or combination therapy before commencing radiation treatment (RT), comprising,

• (a) detecting expression level of at least two biomarkers selected from a panel of biomarkers CD63, AR, HIF-1α, P21, Integrin, TP53, AKT, CD81, BRCA1, CD9, RAD51, BCL2, Snail, EGFR, PI3, PD-L1
• in the biological sample;
• (b) assigning a pre-treatment Radiation Response Index (RRI) index value using a pre-treatment RRI algorithm based on the relative changes or changes in expression of the at least two biomarkers, where a positive RRI value indicates a radiation sensitive tumor (RS-RRI) and a negative RRI value indicates a radiation resistant tumor (RR-RRI);
• and
• (c) classifying a patient based on the RRI value wherein
• (i) a high RS-RRI value is a strong responder (SR) and a candidate for reduced RT dose;
• (ii) a medium RS-RRI value is a responder (R) and a candidate for the standard RT dose;
• (iii) a medium RR-RRI value is a weak responder (WR) and a candidate for dose escalation;
• (iv) a low RR-RRI value is a non-responder (NR) and a candidate for dose escalation, or for alternate therapy or combination therapy, in an individualized manner.

A method for use in classifying a prostate cancer biological sample or patient as (i) strong responder (SR), (ii) responder (R), (iii) weak responder (WR) or (iv) non-responder (NR) to radiation treatment, wherein the classification provides guidance for dose escalation, de-escalation or alternate therapy or combination therapy during or post radiation treatment (RT) comprising,

• (a) detecting in the biological sample expression level of at least one biomarker selected from a panel of biomarkers PI3, P21, CD81, CD63, AR, TP53, HIFα-1, Integrin, RAD51, Snail, CD9, BRCA1, BCL2, EGFR, PD-L1, AKT, wherein PI3 is at least one of the biomarkers;
• (b) assigning a post-treatment Radiation Response Index (RRI) value using a post-treatment RRI algorithm based on the relative change or change in expression of the biomarkers listed in (a), where a positive RRI value indicates a radiation sensitive tumor (RS-RRI) and a negative RRI value indicates a radiation resistant tumor (RR-RRI);
• and
• (c) classifying a patient based on the RRI value wherein
• (i) a high RS-RRI value is a strong responder (SR) and a candidate for reduced RT dose;
• (ii) a medium RS-RRI value is a responder (R) and a candidate for the standard RT dose;
• (iii) a medium RR-RRI value is a weak responder (WR) and a candidate for dose escalation;
• (iv) a low RR-RRI value is a non-responder (NR) and a candidate for dose escalation, or for alternate therapy or combination therapy, in an individualized manner.

A method for use in classifying a biological sample or a prostate cancer patient receiving radiation as stable or having a likelihood of relapse post radiation treatment, by assessing development of radiation resistance, comprising

• (a) detecting in a biological sample or patient expression level of at least one biomarker selected from a panel of biomarkers PI3, P21, CD81, CD63, AR, TP53, HIFα-1, Integrin, RAD51, Snail, CD9, BRCA1, BCL2, EGFR, PD-L1, AKT, wherein PI3 is at least one of the biomarkers;
• (b) assigning a post-treatment Radiation Response Index (RRI) index value using a post-treatment RRI algorithm based on the relative changes or changes in expression of the biomarkers wherein PI3 is at least one of the biomarkers, where a positive RRI value indicates a radiation sensitive tumor (RS-RRI) and a negative RRI value indicates a radiation resistant tumor (RR-RRI);
• and
• (c) classifying the biological sample or patient based on the post-treatment RRI value in (b) as
• (i) stable when the tumor is classified as radiation sensitive;
• (ii) high likelihood of relapse when the tumor is classified as radiation resistant.