Abstract 2799
Background
Durable and complete responses following docetaxel chemotherapy in patients with advanced prostate cancer (PC) are uncommon. Most patients will ultimately experience disease progression within 6-months after initial response. Optimal second line therapy in metastatic castration resistant PC (MCRPC) is not well established and several options are possible. Maintenance treatment in tumpurs as non-small cell lung cancer or ovarian cancer has become a standard improving overall survival (OS), and a phase II study in bladder cancer has demonstrated longer progression-free-survival (PFS) after first-line platinum with vinflunine maintenance.Recently PARP-inhibitors have demonstrated improvement in response and PFS in MCRPC with somatic or germline DNA-repair defects (1-4).
Trial design
IMANOL (NCT03434158) is a phase II trial of olaparib (300 mg tablet bid) maintenance in patients with MCRPC and a complete or partial response to docetaxel treatment and germline or somatic mutation studied by a next-generation sequencing panel of homologous recombination repair genes. Primary endopint is to assess the effect of olaparib maintenance on radiologic PFS in these patients (RECIST v1.1). Secondary endpoints are: effect of maintenance treatment on PSA-PFS and clinical PFS, PSA response rate, safety and tolerability. Exploratory objectives are: to determine the frequency of BRCA and other genes mutations and to stablish a correlation between tumour and germline mutation presence. Previous studies showed that one year rPFS was about 10%. To accept treatment efficacy we will assume that the 12 months rPFS with olaparib maintenance will be at least 30%. An overall simple size of 27 patients achieves 80% power at a 0,05 significance level (alpha) to accept the efficacy of this treatment after completion 6-8 cycles of docetaxel. An accrual time of 12 months in 8 SOGUG centres in Spain is planned.
Clinical trial identification
NCT03434158.
Legal entity responsible for the study
SOGUG.
Funding
AstraZeneca.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
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