Clinical trial

Hormone therapy with or without definitive radiotherapy in metastatic prostate cancer

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Last updated:1st Dec 2016

Identifier: NCT02913859

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	2016-09-21
Study type(s)	Randomised clinical trial
Expected enrolment	60
Study start date	2016-12-01
Estimated primary completion date	2020-12-01

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