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Prostate CancerFeel+NCT02440802

Evaluation and Predictive Value of Genetic Polymorphisms in the Management of Hormonal Treatment of Prostate Cancer

An observational study of Prostate Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 20 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Androgen deprivation therapy (ADT) by surgical castration or administration of LHRH agonists or antagonists is the gold-standard systemic treatment of Prostate Cancer. The efficacy, severity and frequency of side effects of ADT vary from a patient to another. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Saliva sample collection for genetic analyses
How many people
250 participants
Where
20 sitesBelgium
Study dates
Apr 2013to Sep 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Prostate cancer patients for which reimbursed androgen deprivation therapy with a gonadoliberin antagonist is indicated, for aperiod of at least 6 months.

Who may be able to join

  • Prostate cancer patients for which reimbursed ADT with a gonadoliberin antagonist is indicated, for a period of at least 6 months.

Who cannot join

  • Prostate cancer patients who are already receiving ADT with a gonadoliberin antagonist.

Trial locations and contacts

20 sites in 1 country.

Bertrand TOMBAL, MD, PhD contact

003227641409

bertrand.tombal@uclouvain.be

Valentina BUTOESCU, PharmD contact

003227643546

valentina.butoescu@uclouvain.be

20 sites in 1 country

Belgium20 sites, 18 recruiting

  • ASZ Aalst

    Aalst, 9300

    Bernard RAPPE, MD

    Recruiting

  • OLV Aalst

    Aalst, 9300

    Peter SCHATTEMAN, MD, peter.schatteman@olvz-aalst.be

    Recruiting

  • ZNA Middelheim

    Antwerp, 2020

    Tibaut DEBACKER, MD, tibaut.debacker@zna.be

    Recruiting

  • CHu Saint Pierre

    Brussels, 1000

    Kim Entezari, MD

    Recruiting

  • Hopital Erasme

    Brussels, 1070

    Thierry ROUMEGUERE, MD, Thierry.Roumeguere@erasme.ulb.ac.be

    Recruiting

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

    Bertrand TOMBAL, MD, PhD, 003227641409, bertrand.tombal@uclouvain.be

    Valentina BUTOESCU, PharmD, 003227643546, valentina.butoescu@uclouvain.be

    Recruiting

  • AZ Sint Blasius

    Dendermonde, 9200

    Dieter OST, MD, dieter.ost@azsintblasius.be

    Recruiting

  • JESSA Ziekenhuis

    Hasselt, 3500

    Kris VEKEMANS, MD, kris.vekemans@jessazh.be

    Recruiting

  • Jan Ypermanziekenhuis

    Ieper, 8900

    Withdrawn

  • CHU Tivoli

    La Louvière, 7100

    Thierry WILDSCHUTZ, MD, thierry.wildschutz@chu-tivoli.be

    Recruiting

  • CHR Citadelle

    Liège, 4000

    Hubert NICOLAS, MD, hubert.nicolas@chrcitadelle.be

    Recruiting

  • AZ Sint Jozef

    Malle, 2390

    Withdrawn

  • ZNA Jan Palfijn

    Merksem, 2170

    Peter DE JONGE, MD, peter.dejonge@zna.be

    Recruiting

  • CH Mouscron

    Mouscron, 7700

    Philippe FRANCOIS, MD, philippe.francois@chmouscron.be

    Recruiting

  • Clinique Saint Luc Bouge

    Namur, 5004

    Luc DE VISSCHER, MD, luc.devischher@slbo.be

    Recruiting

  • AZ Damiaan

    Ostend, 8400

    Pieter MATTELAER, MD, pmattelaer@azdamiaan.be

    Recruiting

  • AZ Delta

    Roeselare, 8800

    Lieven GOEMAN, MD

    Recruiting

  • AZ St Jozef

    Turnhout, 2300

    Koen Ackaert, MD, koen.ackaert@azturnhout.be

    Recruiting

  • AZ Jan Portaels

    Vilvoorde, 1800

    Geert Martens, MD, geert@urovil.eu

    Recruiting

  • CHU Mont-Godinne

    Yvoir, 5530

    Francis LORGE, MD, francis.lorge@uclouvain.be

    Recruiting

Other trials in Belgium

About this study

Androgen deprivation therapy (ADT) by surgical castration or administration of LHRH agonists or antagonists is the gold-standard systemic treatment of Prostate Cancer. The efficacy, severity and frequency of side effects of ADT vary from a patient to another. The exact cause of this variability is not known, however certain genetic polymorphisms affecting enzymes implicated in the synthesis and metabolism of sex-steroids seem to be involved in these processes.

To perform a longitudinal study to evaluate the prevalence of various genetic polymorphisms affecting genes in the sex-steroid synthesis and metabolism pathway (CYP1A1, CYP1B1, CYP19A1, 17HSD, HSD3B1, AR, ESR1, ESRRG, IL6, TNF-alpha) in men with Prostate Cancer receiving ADT and the possible association between polymorphisms and frequency and severity of side-effects of ADT.

Read the detailed description

Prostate cancer patients for which reimbursed ADT with a gonadoliberin antagonist is indicated, for a period of at least 6 months will lbe enrolled. At 0, 3 months and 6 months of ADT, Aging Males' Symptoms (AMS), EQ-5D (EuroQoL), and hot flashes intensity and frequency (Moyad scale) will be collected, as well as routine assessments: vital signs (blood pressure, heart rate), weight, waist perimeter, fat percentage, Body Mass Index (BMI) and routine laboratory assessments. Determine genotypes of polymorphisms of interest by pyrosequencing. Determine the prevalence of the polymorphisms of interest in the studied population. Perform initial assessment of the association between genetic polymorphisms and questionnaire results.

Conditions
Prostate Cancer
Being tested
Saliva sample collection for genetic analyses
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saliva sample collection for genetic analysesGenetic

    Patients with Prostate cancer receiving androgen deprivation treatment with a GnRH antagonist will be followed-up for 6 months for quality of life. At Baseline, 3 months and 6 months of treatment QoL data will be collected, as well as body parameters. At Baseline, once, a saliva sample will be collected for genetic analyses.

Study groups in NCT02440802
Study groupRoleWhat they receive
Gonadoliberin antagonist treatmentSingle arm study, all patients are treated the same way. Saliva sample collection for genetic analyses.
Receives: Genetic: Saliva sample collection for genetic analyses

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aging Males Symptoms questionnaire

    Measured: 0 months

  2. Aging Males Symptoms questionnaire

    Measured: 3 months

  3. Aging Males Symptoms questionnaire

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study startApr 2013
  3. Primary completionSep 2017 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02440802
Sponsor's protocol ID
B403201317385
Acronym
Feel+
Status last verified
Oct 2016
First submitted
30 Apr 2015
Last updated
18 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Mottet N, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Schmid HP, Van der Kwast T, Wiegel T, Zattoni F, Heidenreich A. EAU guidelines on prostate cancer. Part II: Treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur Urol. 2011 Apr;59(4):572-83. doi: 10.1016/j.eururo.2011.01.025. Epub 2011 Jan 25.

    PubMed 21315502

  • Mohile SG, Mustian K, Bylow K, Hall W, Dale W. Management of complications of androgen deprivation therapy in the older man. Crit Rev Oncol Hematol. 2009 Jun;70(3):235-55. doi: 10.1016/j.critrevonc.2008.09.004. Epub 2008 Oct 25.

    PubMed 18952456

  • Allain TJ. Prostate cancer, osteoporosis and fracture risk. Gerontology. 2006;52(2):107-10. doi: 10.1159/000090956.

    PubMed 16508318

  • Benton MJ, White A. Osteoporosis: recommendations for resistance exercise and supplementation with calcium and vitamin D to promote bone health. J Community Health Nurs. 2006 Winter;23(4):201-11. doi: 10.1207/s15327655jchn2304_1.

    PubMed 17064230

  • Diamond TH, Higano CS, Smith MR, Guise TA, Singer FR. Osteoporosis in men with prostate carcinoma receiving androgen-deprivation therapy: recommendations for diagnosis and therapies. Cancer. 2004 Mar 1;100(5):892-9. doi: 10.1002/cncr.20056.

    PubMed 14983482

  • McGrath SA, Diamond T. Osteoporosis as a complication of orchiectomy in 2 elderly men with prostatic cancer. J Urol. 1995 Aug;154(2 Pt 1):535-6. doi: 10.1097/00005392-199508000-00057. No abstract available.

    PubMed 7609129

  • Oefelein MG, Ricchuiti V, Conrad W, Seftel A, Bodner D, Goldman H, Resnick M. Skeletal fracture associated with androgen suppression induced osteoporosis: the clinical incidence and risk factors for patients with prostate cancer. J Urol. 2001 Nov;166(5):1724-8. doi: 10.1016/s0022-5347(05)65661-3.

    PubMed 11586210

  • Braga-Basaria M, Dobs AS, Muller DC, Carducci MA, John M, Egan J, Basaria S. Metabolic syndrome in men with prostate cancer undergoing long-term androgen-deprivation therapy. J Clin Oncol. 2006 Aug 20;24(24):3979-83. doi: 10.1200/JCO.2006.05.9741.

    PubMed 16921050

  • Galvao DA, Spry NA, Taaffe DR, Newton RU, Stanley J, Shannon T, Rowling C, Prince R. Changes in muscle, fat and bone mass after 36 weeks of maximal androgen blockade for prostate cancer. BJU Int. 2008 Jul;102(1):44-7. doi: 10.1111/j.1464-410X.2008.07539.x. Epub 2008 Mar 11.

    PubMed 18336606

  • Galvao DA, Taaffe DR, Spry N, Joseph D, Turner D, Newton RU. Reduced muscle strength and functional performance in men with prostate cancer undergoing androgen suppression: a comprehensive cross-sectional investigation. Prostate Cancer Prostatic Dis. 2009;12(2):198-203. doi: 10.1038/pcan.2008.51. Epub 2008 Oct 14.

    PubMed 18852703

  • Smith MR, Lee H, McGovern F, Fallon MA, Goode M, Zietman AL, Finkelstein JS. Metabolic changes during gonadotropin-releasing hormone agonist therapy for prostate cancer: differences from the classic metabolic syndrome. Cancer. 2008 May 15;112(10):2188-94. doi: 10.1002/cncr.23440.

    PubMed 18348297

  • Smith MR, O'Malley AJ, Keating NL. Gonadotrophin-releasing hormone agonists, diabetes and cardiovascular disease in men with prostate cancer: which metabolic syndrome? BJU Int. 2008 Jun;101(11):1335-6. doi: 10.1111/j.1464-410X.2008.07707.x. No abstract available.

    PubMed 18454791

  • D'Amico AV, Denham JW, Bolla M, Collette L, Lamb DS, Tai KH, Steigler A, Chen MH. Short- vs long-term androgen suppression plus external beam radiation therapy and survival in men of advanced age with node-negative high-risk adenocarcinoma of the prostate. Cancer. 2007 May 15;109(10):2004-10. doi: 10.1002/cncr.22628.

    PubMed 17397033

  • D'Amico AV, Denham JW, Crook J, Chen MH, Goldhaber SZ, Lamb DS, Joseph D, Tai KH, Malone S, Ludgate C, Steigler A, Kantoff PW. Influence of androgen suppression therapy for prostate cancer on the frequency and timing of fatal myocardial infarctions. J Clin Oncol. 2007 Jun 10;25(17):2420-5. doi: 10.1200/JCO.2006.09.3369.

    PubMed 17557956

  • D'Amico AV, Loffredo M, Renshaw AA, Loffredo B, Chen MH. Six-month androgen suppression plus radiation therapy compared with radiation therapy alone for men with prostate cancer and a rapidly increasing pretreatment prostate-specific antigen level. J Clin Oncol. 2006 Sep 1;24(25):4190-5. doi: 10.1200/JCO.2006.06.8239.

    PubMed 16943536

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 20 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bertrand TOMBAL, MD, PhD (003227641409, bertrand.tombal@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aging Males Symptoms questionnaire (time frame: 0 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02440802, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.

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Feel+ Clinical Trial NCT02440802 | AzTrials