NCT02913859

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

September 13, 2016

Last Update Submit

October 10, 2018

Conditions

Prostate Cancer

Keywords

prostate cancerhormone-sensitivemetastasis

Outcome Measures

Primary Outcomes (1)

  • Disease progression-free survival

    Time to prostate specific antigen (PSA) progression

    4 years

Secondary Outcomes (2)

  • Prostate, bone marrow and viscera progression-free survival

    4 years

  • Expression of integrins

    4 years

Study Arms (2)

pelvic radiotherapy

EXPERIMENTAL

long-term hormonal therapy (LHRH agonist and/or antiandrogens) plus radiotherapy to the pelvis and prostate

Radiation: Radiotherapy to the pelvisDrug: Hormonal therapy (LHRH agonist and/or antiandrogens)

No pelvic radiotherapy

ACTIVE COMPARATOR

long-term hormonal therapy ( LHRH agonist and/or antiandrogens) alone

Drug: Hormonal therapy (LHRH agonist and/or antiandrogens)

Interventions

Radiotherapy to the pelvisRADIATION

Radiotherapy to the pelvis and prostate

pelvic radiotherapy
Hormonal therapy (LHRH agonist and/or antiandrogens)DRUG

life-long hormonal therapy (LHRH agonist and/or antiandrogens)

Also known as: medical castration and/or antiandrogens
No pelvic radiotherapypelvic radiotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients with newly diagnosed metastatic prostate cancer
  • Androgen dependent disease measured by declining PSA
  • ECOG PS 0 or 1
  • Life-expectancy based on comorbid conditions \>2 years
  • Ability to understand and willingness to sign informed consent
  • Must be candidate for radiation therapy

You may not qualify if:

  • Poor performance status, history of connective tissue disorder
  • Psychiatric or medical conditions which would not allow the patient to undergo the proposed treatment safely
  • Known brain metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ana Frobe

Zagreb, 10000, Croatia

RECRUITING

Related Publications (9)

  • Culp SH, Schellhammer PF, Williams MB. Might men diagnosed with metastatic prostate cancer benefit from definitive treatment of the primary tumor? A SEER-based study. Eur Urol. 2014 Jun;65(6):1058-66. doi: 10.1016/j.eururo.2013.11.012. Epub 2013 Nov 20.

    PMID: 24290503RESULT

  • Fossati N, Trinh QD, Sammon J, Sood A, Larcher A, Sun M, Karakiewicz P, Guazzoni G, Montorsi F, Briganti A, Menon M, Abdollah F. Identifying optimal candidates for local treatment of the primary tumor among patients diagnosed with metastatic prostate cancer: a SEER-based study. Eur Urol. 2015 Jan;67(1):3-6. doi: 10.1016/j.eururo.2014.08.056. Epub 2014 Sep 10.

    PMID: 25217422RESULT

  • Gratzke C, Engel J, Stief CG. Role of radical prostatectomy in metastatic prostate cancer: data from the Munich Cancer Registry. Eur Urol. 2014 Sep;66(3):602-3. doi: 10.1016/j.eururo.2014.04.009. Epub 2014 May 10. No abstract available.

    PMID: 24821581RESULT

  • Psaila B, Lyden D. The metastatic niche: adapting the foreign soil. Nat Rev Cancer. 2009 Apr;9(4):285-93. doi: 10.1038/nrc2621.

    PMID: 19308068RESULT

  • Ganguly SS, Li X, Miranti CK. The host microenvironment influences prostate cancer invasion, systemic spread, bone colonization, and osteoblastic metastasis. Front Oncol. 2014 Dec 15;4:364. doi: 10.3389/fonc.2014.00364. eCollection 2014.

    PMID: 25566502RESULT

  • Shinka T, Onodera D, Tanaka T, Shoji N, Miyazaki T, Moriuchi T, Fukumoto T. Serotonin synthesis and metabolism-related molecules in a human prostate cancer cell line. Oncol Lett. 2011 Mar;2(2):211-215. doi: 10.3892/ol.2011.244. Epub 2011 Jan 20.

    PMID: 22866066RESULT

  • Dizeyi N, Bjartell A, Nilsson E, Hansson J, Gadaleanu V, Cross N, Abrahamsson PA. Expression of serotonin receptors and role of serotonin in human prostate cancer tissue and cell lines. Prostate. 2004 May 15;59(3):328-36. doi: 10.1002/pros.10374.

    PMID: 15042609RESULT

  • Widmark A, Klepp O, Solberg A, Damber JE, Angelsen A, Fransson P, Lund JA, Tasdemir I, Hoyer M, Wiklund F, Fossa SD; Scandinavian Prostate Cancer Group Study 7; Swedish Association for Urological Oncology 3. Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial. Lancet. 2009 Jan 24;373(9660):301-8. doi: 10.1016/S0140-6736(08)61815-2. Epub 2008 Dec 16.

    PMID: 19091394RESULT

  • Warde P, Mason M, Ding K, Kirkbride P, Brundage M, Cowan R, Gospodarowicz M, Sanders K, Kostashuk E, Swanson G, Barber J, Hiltz A, Parmar MK, Sathya J, Anderson J, Hayter C, Hetherington J, Sydes MR, Parulekar W; NCIC CTG PR.3/MRC UK PR07 investigators. Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial. Lancet. 2011 Dec 17;378(9809):2104-11. doi: 10.1016/S0140-6736(11)61095-7. Epub 2011 Nov 2.

    PMID: 22056152RESULT

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ana Fröbe, MD, PhD

    UHC Sestre Milosrdnice, Department of Oncology and Nuclear Medicine, Vinogradska 29, 10 000 Zagreb, Croatia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Fröbe, MD, PhD

CONTACT

+38513787111afrobe@irb.hr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Prof.

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 26, 2016

Study Start

September 1, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

Locations

CR(1)