Data from Clinicaltrials.gov - Curated by EPG Health - Last updated 28 September 2016

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...

purpose

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).

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hormone Therapy With or Without Definitive Radiotherapy in Metastatic Prostate Cancer
 

Arms Assigned Interventions
Experimental: pelvic radiotherapy
long-term hormonal therapy (LHRH agonist and/or antiandrogens) plus radiotherapy to the pelvis and prostate
Radiation: Radiotherapy to the pelvis
Radiotherapy to the pelvis and prostate
Drug: Hormonal therapy (LHRH agonist and/or antiandrogens)
life-long hormonal therapy (LHRH agonist and/or antiandrogens)
Other Name: medical castration and/or antiandrogens
Active Comparator: No pelvic radiotherapy
long-term hormonal therapy ( LHRH agonist and/or antiandrogens) alone
Drug: Hormonal therapy (LHRH agonist and/or antiandrogens)
life-long hormonal therapy (LHRH agonist and/or antiandrogens)
Other Name: medical castration and/or antiandrogens
Category Value
Date last updated at source 21-Sep-16
Recruiting in Croatia (Hrvatska)
Study type(s) Randomised clinical trial
Expected enrolment 60
Study start date 01-Dec-16
Estimated primary completion date 01-Dec-20

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