CompletedNot Applicable

Study In Urology Practices Looking At Impact Of OncotypeDX GPS Test On Men Choosing And Remaining On Active Surveillance

489 participantsStarted 2014-07-01

Plain-language summary

Genomic Health's OncotypeDX® Prostate Cancer Assay is a commercially available laboratory test that measures the activity of certain genes in prostate cancer. The purpose of this study is to better understand how the use of this test result impacts or affects treatment decisions for men newly diagnosed with low risk prostate cancer, their confidence in the treatment decision, and the effects and side effects of the treatment chosen on certain aspects of Quality of Life. This study will also determine what percentage of men choosing an active monitoring program as prescribed by their doctor remain on Active Surveillance and have avoided any treatment at one year after diagnosis after receiving the assay result.

Who can participate

Age range50 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical stage T1c/T2 * PSA ≤ 20ng/mL * Biopsy GS ≤ 6 with any number of cores positive, or Biopsy GS 3+4 disease with ≤3 positive cores or ≤ 33% positive cores * The patient must be ≥ 50 years of age * The patient must have a life expectancy of \> 10 years * Patient must be able to give consent in English or Spanish Exclusion Criteria: * Clinical stage T3a or above * PSA \> 20ng/mL * Biopsy GS 4+3 or \> 8 * Known metastatic prostate cancer * Positive biopsy for prostate cancer \> 3 months ago * Treatment decision has already been made * Insufficient tumor in prostate biopsy tissue to perform the assay * Treatment with androgen deprivation therapy (ADT) prior to prostate biopsy * Diagnosis made by transurethral resection of prostate (TURP) shavings * Any psychiatric or psychological conditions * Contraindications to primary treatment according to physician's judgment

What they're measuring

Rate of persistence on Active Surveillance at 1 and 2 years after receiving the OncotypeDX Genomic Prostate Score (GPS)

Timeframe: The analysis will estimate the absolute magnitude of the rates of persistence at these two time points (1 and 2 years after receiving GPS)

Trial details

NCT IDNCT03502213

SponsorGenomic Health®, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-06-30