CaNCaP03 - Cambridge Neoadjuvant Cancer of the Prostate 3
Research type
Research Study
Full title
A Study into the Pharmacodynamic Biomarker Effects of Olaparib (a PARP Inhibitor) ± Degarelix (a GnRH antagonist) given Prior to Radical Prostatectomy.
IRAS ID
166367
Contact name
Simon Christopher Pacey
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge
Eudract number
2014-004417-86
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
In the UK prostate cancer is the fourth most common cause of cancer deaths. At diagnosis around 15% of men with prostate cancer are found to have high risk disease and are significantly more likely to suffer treatment failure from radical therapy, disease progression and mortality. Standard treatment for localised prostate cancer is prostate gland removal surgery (radical prostatectomy) or radiation therapy. Giving treatment in the window between diagnosis and surgery may help delay or prevent relapse in men with high risk prostate cancer.
This study will investigate the action(s) of olaparib (a Poly ADP-Ribose Polymerase (PARP) inhibitor) given alone or in combination with degarelix (a Gonadotropin-releasing hormone(GnRH) antagonist) to patients with prostate cancer prior to radical prostatectomy. The primary objective is the degree of PARP inhibition in prostate tumour tissue samples following treatment with olaparib (± degarelix). Secondary objectives include assessing the feasibility, safety and tolerability of a short course of olaparib (± degarelix) and assessing preliminary evidence of tumour response, e.g. pathological changes. Exploratory endpoints include the measurement of biological effects caused by olaparib (± degarelix) treatment and biomarker changes.
PARP inhibitors are molecules which prevent the repair of damaged DNA (genetic material) within cancer cells. Olaparib is a PARP inhibitor which has an anti-tumour effect in patients with breast and ovarian cancer. Laboratory studies indicate that olaparib may have a similar effect against prostate cancer. Degarelix is a means of chemical castration which causes the growth of prostate cancer cells to slow or stop.
A maximum of twenty men (aged 18-) with intermediate/high risk prostate cancer suitable for radical prostatectomy will be recruited over a period of 18 months. Patients will be treated for two weeks before surgery with olaparib either alone or in combination with degarelix.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0304
Date of REC Opinion
4 Aug 2016
REC opinion
Further Information Favourable Opinion