Hormone Therapy With or Without Definitive Radiotherapy in Metastatic Prostate Cancer

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital "Sestre Milosrdnice"
• Treatments: Androgen Antagonists; Hormones

Criteria

Inclusion Criteria:

1. Male patients with newly diagnosed metastatic prostate cancer

2. Androgen dependent disease measured by declining PSA

3. ECOG PS 0 or 1

4. Life-expectancy based on comorbid conditions >2 years

5. Ability to understand and willingness to sign informed consent

6. Must be candidate for radiation therapy

Exclusion Criteria:

1. Poor performance status, history of connective tissue disorder

2. Psychiatric or medical conditions which would not allow the patient to undergo the proposed treatment safely

3. Known brain metastasis