N/A
Completed N=356
Genomics in Michigan Impacting Observation or Radiation
Source: ClinicalTrials.gov NCT02783950 ↗Enrolled (actual)
356
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy) — 19; 12 Participants — p=0.27
Summary
To determine the impact of Decipher test results on adjuvant treatment decisions of high-risk post-RP patients with undetectable post-op prostate specific antigen (PSA) compared to clinical factors alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy) |
19; 12 | 0.27 |
| SECONDARY Time (From Randomization) to Adjuvant Treatment Administration |
259; 233.5 | 0.70 |
| SECONDARY Time (From Randomization) to Salvage Treatment Administration |
— | — |
| SECONDARY Time (From Randomization) to Biochemical Recurrence (BCR) |
— | — |
| SECONDARY Time (From Randomization) to Metastatic Disease (Regional or Distant) |
— | — |
| SECONDARY Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Prostate cancer patients who have undergone radical prostatectomy
- PSA < 0.1 ng/ml at enrollment
- At least one of the following:
- pT3 (seminal vesicle invasion or extraprostatic extension), or
- Positive surgical margins
- Radical prostatectomy within one year of enrollment
Exclusion Criteria
- Individuals who have any of the following will not be eligible to participate:
- Have regional or distant metastatic disease
- Received any radiation or hormone therapy (neo-adjuvant, adjuvant, or salvage)
- Node positive
Data sourced from ClinicalTrials.gov (NCT02783950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.