Hormone Therapy With or Without Definitive Radiotherapy in Metastatic Prostate Cancer

Uncategorized

Hormone Therapy With or Without Definitive Radiotherapy in Metastatic Prostate Cancer

Condition: Prostate Cancer

Intervention:

  • Radiation: Radiotherapy to the pelvis
  • Drug: Hormonal therapy (LHRH agonist and/or antiandrogens)

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

Clinical Trials Identifier NCT 8-digits: NCT02913859

Sponsor: University Hospital “Sestre Milosrdnice”

Primary Outcome Measures:

  • Measure: Disease progression-free survival
  • Time Frame: 4 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Prostate, bone marrow and viscera progression-free survival
  • Time Frame: 4 years
  • Safety Issue:
  • Measure: Expression of integrins
  • Time Frame: 4 years
  • Safety Issue:

Estimated Enrollment: 60

Study Start Date: September 1, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 80 Years
  • Gender: Male

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

Contact:

  • Ana Fröbe, MD, PhD
  • +38513787111 Ext. 468

Location:

  • Ana Frobe
  • Zagreb 10000 Croatia

View trial on ClinicalTrials.gov

X