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Trial record 74 of 1435 for:    prostate cancer AND radiation

Hormone Therapy With or Without Definitive Radiotherapy in Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02913859
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Ana Frobe, University Hospital "Sestre Milosrdnice"

Brief 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).


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiotherapy to the pelvis Drug: Hormonal therapy (LHRH agonist and/or antiandrogens) Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hormone Therapy With or Without Definitive Radiotherapy in Metastatic Prostate Cancer
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Disease progression-free survival [ Time Frame: 4 years ]
    Time to prostate specific antigen (PSA) progression


Secondary Outcome Measures :
  1. Prostate, bone marrow and viscera progression-free survival [ Time Frame: 4 years ]
    Number of participants with radiographic disease progression in prostate, bone and visceral organs

  2. Expression of integrins [ Time Frame: 4 years ]
    Number of participants with expression of analysed genes : 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913859


Contacts
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Contact: Ana Fröbe, MD, PhD +38513787111 ext 468 afrobe@irb.hr

Locations
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Croatia
Ana Frobe Recruiting
Zagreb, Croatia, 10000
Contact: Ana Frobe, MD    +38513787468    afrobe@irb.hr   
Contact: Marin Prpic, MD    +38513787389    m.prpic@kbcsm.hr   
Sponsors and Collaborators
University Hospital "Sestre Milosrdnice"
Investigators
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Principal Investigator: Ana Fröbe, MD, PhD UHC Sestre Milosrdnice, Department of Oncology and Nuclear Medicine, Vinogradska 29, 10 000 Zagreb, Croatia

Additional Information:
Publications of Results:

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Responsible Party: Ana Frobe, MD, PhD, Prof., University Hospital "Sestre Milosrdnice"
ClinicalTrials.gov Identifier: NCT02913859     History of Changes
Other Study ID Numbers: UHSestre
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Frobe, University Hospital "Sestre Milosrdnice":
prostate cancer
hormone-sensitive
metastasis
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Hormones
Androgen Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormone Antagonists