Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation

NCT01729676 | Completed

• 1 other identifier: 000059
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

French epidemiological data have shown a heterogeneous distribution of the risk of mortality from prostate cancer according to region. The main objective is to describe the distribution of prostate cancer stages when first line hormonal therapy is introduced (overall and by region).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Estimated percentage of different prostate cancer stages (overall and by region)

  The stages of prostate cancer are classified as locally advanced, metastatic and biological recurrence.

  During a single consultation when first-line prostate cancer hormone therapy is started

Secondary Outcomes (2)

• The characteristics of the patients with prostate cancer by region

  During a single consultation when first-line prostate cancer hormone therapy is started

• The influence of regional factors on staging of prostate cancer

  During a single consultation when first-line prostate cancer hormone therapy is started

Study Arms (1)

Group A

Degarelix or gonadotrophin releasing hormone (GnRH) agonist for treatment of prostate cancer according to physicians current practice

Drug: Degarelix or GnRH agonist

Interventions

Degarelix or GnRH agonist DRUG

Degarelix or GnRH agonist for treatment of prostate cancer according to physicians current practice

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men never previously treated with hormononal therapy for prostate cancer

You may qualify if:

• Patients with histologically demonstrated prostatic adenocarcinoma.
• Patients never previously treated with hormonal therapy for prostate cancer.
• Patients eligible for hormonal therapy after initial consultation (alone or in combination with curative treatment).
• Patients agreeing to the collection of personal health data for the purposes of the study.
• Patients with locally advanced or metastatic prostatic cancer tumours or a biological recurrence after curative treatment.

You may not qualify if:

• Patients having received or currently receiving hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor antagonists, antiandrogens, oestrogens, 5 alpha reductase inhibitors).

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Hôpital Robert Boulin

Libourne, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: November 20, 2012
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

FR (1)