Prostate Cancer Clinical Trial
Official title:
A Study Into the Pharmacodynamic Biomarker Effects of Olaparib (a PARP Inhibitor) ± Degarelix (a GnRH Antagonist) Given Prior to Radical Prostatectomy
Despite recent advances in the treatment of Castrate-Resistant Prostate Cancer (CRPC), there
remains an unmet medical need to identify and optimise additional treatment for those
patients with early prostate cancer who are at greatest risk of relapse following first-line
treatment with curative intent.
This is a phase I study investigating the feasibility and tolerability of a short course of
neoadjuvant treatment with olaparib, either as a monotherapy or in combination with
degarelix) given in the window-of-opportunity prior to radical prostatectomy in men with
early, localised intermediate-/high- risk prostate cancer. Our primary objective is to
determine the pharmacodynamic biomarker effects of olaparib (a PARP inhibitor) in this
patient population.
Participants will receive either single agent olaparib or olaparib in combination with
degarelix (androgen deprivation) for two weeks prior to routine radical prostatectomy. We
will use immunohistochemistry to quantify changes in the levels of biomarkers of PARP
inhibition, e.g. PAR, gamma H2AX, pH2A(s129) and Rad51 foci, using tumour samples taken at
baseline and at the time of radical prostatectomy. An intra-operative prostate biopsy will
permit us to examine biomarker variability between the samples.
The incidence and severity of Adverse Events will be documented and we will assess the number
of trial participants who undergo surgery on schedule. We will assess preliminary evidence of
tumour response, e.g. pathological changes and Prostate Specific Antigen (PSA). We also
intend to investigate changes to the ctDNA profile by comparing blood samples collected
throughout the study.
n/a
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