PSA

Patient-based response defined as a decline of serum PSA ≥50% at 12th weeks (after 2 cycles) after treatment initiation.

Number of patients with radiographic progression free survival (rPFS) rate

Target biomarker identification

Assessment of the importance of the imaging test in the screening of significant prostate cancer in asymptomatic men, compared with PSA screening: Proportion of positive MRI findings

PSA-RR

Ability to detect and quantify biomarkers such as PSA in samples using biosensors platform

serum PSA level

Prostate Specific Antigen (PSA) Response Rate

PSA-concentration

Median Time to prostate-specific antigen recurrence

PSA Response Rate, Defined as >= 50% Decline in PSA From Baseline Maintained for at Least 3 Weeks and Measured by the Same Laboratory, and Without Evidence of Other Disease Progression Documented at Time of Confirmatory Values

Number of Participants With Change in PSA Response

Proportion of Patients With PSA Decline by 50% From Baseline

Change in CD8+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies

Biomarker Changes

Total-PSA (tPSA) Levels

PSA antibody levels are compared between baseline and follow-up at 12 weeks, as well as 24 weeks, using Wilcoxon signed-rank test

Parts A and B: Anti-tumour activity by measurement of changes in circulating prostate-specific antigen (PSA)

Prostate-specific antigen (PSA)

DB Phase: Time to Prostate-Specific Antigen Progression (PSA)

Assesment of Serum Zinc/PSA Ratio in Patients With Prostate Cancer and Benign Prostatic Diseases

Percentage of participants achieving Prostate-Specific Antigen (PSA) response up to 12 weeks

Confirmed Prostate-specific Antigen (PSA) Response Rate

Percentage of Patients Who Achieve an Undetectable PSA (=< 0.2 ng/ml)

PSA Response Analyzed Using the PCWG2 Definition

Proportion of subjects who have ≥50% PSA decline at any time on study from the start of treatment with seviteronel.

Percentage of Participants Who Developed Psoriatic Arthritis (PsA)

Proportion of Patients Who Experience a PSA (Prostate-Specific Antigen) Decline of at Least 30%

Serum PSA values at 7 months

PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA

PSA value compare to Choline and Citrate levels as measured with MR-spectroscopic imaging as predictive factor of the response to treatment

PSA Response Rate With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer

Proportion of Patients With PSA Response

Percentage of Participants With Prostate Specific Antigen (PSA) Response

Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level

Number of Patients With a PSA Response

Overall Response Rate as Measured by RECIST Criteria and PSA Criteria