Hormone Therapy With or Without Definitive Radiotherapy in Metastatic Prostate Cancer
Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
PART I
Hormone therapy with or without definitive radiotherapy in metastatic prostate cancer
The goal of this clinical study PART I is to determine impact of radiotherapy treatment in
combination with standard androgen deprivation therapy comparing with androgen deprivation
therapy alone at controlling metastatic prostate cancer. The primary objective: to determine
disease progression free survival in man with metastatic (M1) prostate cancer (PC) undergoing
androgen deprivation therapy with or without definitive radiotherapy of the primary tumor.The
secondary objective: to determine disease progression (local, bone marrow, visceral) in men
with metastatic prostate cancer (M1PC) undergoing systemic therapy with/without definitive
radiotherapy of the primary tumor, to determine expression in number of genes analysed 8: 2
housekeeping genes; integrin subunits αv, β3, β5, α4β1 ; 3 EMT markers N-cadherin,
E-cadherin, vimentin before radiotherapy, after radiotherapy and at the time of the disease
progression , to determine plasma serotonin (5HT, 5 hydroxytryptamine). Subgroup analysis in
locally advanced prostate cancer (serves as a control group for integrins analysis): to
determine expression in number of genes analysed 8: 2 housekeeping genes; integrin subunits
αv, β3, β5, α4β1 ; 3 epithelial-mesenchymal transition (EMT) markers N-cadherin, E-cadherin,
vimentin before radiotherapy, after radiotherapy and at the time of the disease progression.
PART II
Identification of genetic determinants of disease progression and castrate resistance in
metastatic prostate cancer.
The goal of this clinical study PART II is to assess feasibility of genomic testing in the
multidisciplinary clinical management of metastatic prostate cancer, to gain insight in
specific genomic signature(s) of progressive metastatic prostate cancer in the natural course
of disease spanning from primary tumor to metastases, to test if 'treatment selection' and/or
'treatment adaptation' as means of evolutionary pressures represent the mechanistic models of
castrate resistance and ultimate treatment failure following course of androgen deprivation
therapy (ADT).