Clinical trial NCT02783950: Genomics in Michigan Impacting Observation or Radiation
Official title: Genomics in Michigan Impacting Observation or Radiation (G-MINOR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Genomics
Adjuvant Treatment
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Michigan Urological Surgery Improvement Collaborative (MUSIC)
name: GenomeDx Biosciences Corp
First posted: 2016-05-26
Enrollment: 356
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: This prospective, randomized trial will compare the receipt of adjuvant therapy for high-risk radical prostatectomy (RP) patients who undergo Decipher testing to those who do not. 350 subjects from within the statewide Michigan Urological Surgery Improvement Collaborative (MUSIC) will be randomized to either a Genomic Classifier (Decipher) or Usual-Care-Based (UC) strategy for a period of three months. If enrolled during the Genomic Classifier period, both subjects and their treating physician will be provided Decipher results and CAPRA-S scores. In the UC periods, CAPRA-S scores but not Decipher results will be provided.

The enrollment goal, initially and throughout the study, was to enroll 350 evaluable patients. During the study, the target accrual goal was raised to 550 patients to allow more flexibility among sites to achieve the enrollment goal of 350 evaluable patients.

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

Primary outcomes:
measure: Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy)
timeFrame: within 18 months of radical prostatectomy
Secondary outcomes:
measure: Time (From Randomization) to Adjuvant Treatment Administration
timeFrame: Up to 18 months post randomization
measure: Time (From Randomization) to Salvage Treatment Administration
timeFrame: Up to 5 years post randomization
measure: Time (From Randomization) to Biochemical Recurrence (BCR)
timeFrame: Up to 5 years post randomization
measure: Time (From Randomization) to Metastatic Disease (Regional or Distant)
timeFrame: Up to 5 years post randomization
measure: Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO)
timeFrame: Up to 24 months post radical prostatectomy
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital and Health Systems
state: Michigan
city: Detroit
country: United States
facility: Wayne State University/Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Urologic Consultants
state: Michigan
city: Grand Rapids
country: United States
facility: Urology Associates of Grand Rapids
state: Michigan
city: Grand Rapids
country: United States
facility: Michigan Urological Clinic
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group- Urology
state: Michigan
city: Grand Rapids
country: United States
facility: Urology Surgeons, PC
state: Michigan
city: Royal Oak
country: United States
facility: Comprehensive Medical Center, PLLC
state: Michigan
city: Saginaw
country: United States
facility: Tri-City Urology
state: Michigan
city: Traverse City
country: United States
facility: Bay Area Urology Associates, PC
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology-Town Center
state: Michigan
city: Ypsilanti
country: United States
facility: IHA Urology at St. Joe's Ann Arbor
state: Michigan
Study officials:
affiliation: University of Michigan
name: Todd Morgan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Michael Cher, MD
role: PRINCIPAL_INVESTIGATOR
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