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Open Registry Measuring Impact of Genomic Testing on Treatment of Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT01954004
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : June 2, 2015
Sponsor:
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

Brief Summary:
This registry is intended to evaluate the impact of genomic test results towards selecting a first-line therapy option for newly diagnosed localized prostate cancer patients.

Condition or disease
Prostate Cancer

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1270 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients
Study Start Date : April 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option implemented following results of genomic risk assessment testing (Prolaris®). [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following review of the genomic test results (prior to patient consultation) [ Time Frame: 1 month ]
  2. Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient. [ Time Frame: 2 months ]

Other Outcome Measures:
  1. • The mean change in the physician's likelihood of recommending non-interventional therapy (watchful waiting or active surveillance) post-genomic testing compared to pre-genomic testing. [ Time Frame: 4 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer
Criteria

Inclusion Criteria:

  • Newly diagnosed (≤6 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics.
  • Clinically localized (no evidence on clinical or imaging studies of advanced disease).
  • No hormonal therapy including LHRH (luteinizing hormone-releasing hormone) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.
  • Sufficient amount of tissue remains from biopsy to perform genomic testing.

Exclusion Criteria:

  • Patients with a known history of hypogonadism

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): NCT01954004


Locations
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United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Myriad Genetic Laboratories, Inc.
Investigators
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Study Director: Richard Wenstrup, MD Myriad Genetic Laboratories, Inc.

Additional Information:

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Responsible Party: Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01954004     History of Changes
Other Study ID Numbers: PROCEDE-1000
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases